TDS: Individual Differences in the Response to Drugs
Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT02485158
Collaborator
(none)
28
2
5
Study Details
Study Description
Brief Summary
The purpose of this study is to examine whether individual differences in acute responses to drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who experience greater rewarding effects from one drug will also experience more rewarding effects from the other drugs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
Here, the investigators aim to investigate whether individuals exhibit similar responses to three different drugs from different classes. This study used a within-subjects design (total N = 24). All subjects received alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC) in a double-blind, double-dummy fashion. Subjects completed six sessions wherein they received either alcohol, amphetamine, or THC, or corresponding placebos, on separate days. Subjects completed questionnaires about mood, general drug effects, and specific drug effects.
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol
Study Start Date
:
Jul 1, 2013
Actual Primary Completion Date
:
Dec 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMP, ALC, THC or Placebo 1 All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions. |
Drug: THC
This is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Other Names:
Drug: AMP
This is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Other Names:
Drug: ALC
This is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Other Names:
Drug: Placebo capsules
This is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC.
Other Names:
Drug: Placebo beverage
This is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.
|
| Experimental: AMP, ALC, THC or Placebo 2 All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions. |
Drug: THC
This is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Other Names:
Drug: AMP
This is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Other Names:
Drug: ALC
This is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Other Names:
Drug: Placebo capsules
This is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC.
Other Names:
Drug: Placebo beverage
This is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.
|
Outcome Measures
Primary Outcome Measures
- Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration [Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion [Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.]
Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration [Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 30 minutes after drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 90 minutes after drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 120 minutes after drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 150 minutes after drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 180 minutes after drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
- Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration [Measured 15 minutes prior to capsule administration and 210 minutes after drink administration]
Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
English fluency
-
High school education
-
BMI between 19 and 26
-
Individuals who report drinking at least 4 alcoholic drinks on one occasion in the past month
Exclusion Criteria:
-
individuals with a medical condition contraindicating study participation, as determined by our physician
-
individuals regularly using any contraindicated medications
-
individuals with current dependence on any drug or past dependence on alcohol, marijuana or stimulants
-
individuals with a past year DSM-IV Axis I mood, anxiety, eating, or psychotic disorder
-
women who are pregnant, nursing, or planning to become pregnant in the next 3 months
-
individuals who drink more than 10 alcoholic drinks per week
-
individuals who currently use i) any illicit drug weekly or more frequently, ii) stimulant prescription drugs, iii) more than 10 cigarettes per week, and iv) more than 3 cups of coffee per day
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Chicago
Investigators
- Principal Investigator: Harriet de Wit, PhD, University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT02485158
Other Study ID Numbers:
- IRB13-0534
First Posted:
Jun 30, 2015
Last Update Posted:
Nov 29, 2016
Last Verified:
Oct 1, 2016
Keywords provided by University of Chicago
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Healthy social drinkers were recruited from the Chicago area through flyers and online advertisements, from June 2013 through February 2014. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Healthy Adult Volunteers |
|---|---|
| Arm/Group Description | 24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo. |
| Period Title: Overall Study | |
| STARTED | 28 |
| COMPLETED | 24 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Healthy Adult Volunteers |
|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo. |
| Overall Participants | 28 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
24.6
(2.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
16
57.1%
|
| Male |
12
42.9%
|
Outcome Measures
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
4.79
(7.22)
|
12.83
(18.78)
|
11.08
(21.09)
|
12.17
(19.90)
|
9.38
(11.12)
|
4.5
(13.16)
|
| DEQ Like |
16.08
(27.47)
|
18.67
(28.81)
|
11.75
(21.84)
|
9.0
(18.42)
|
10.04
(17.90)
|
9.67
(24.14)
|
| DEQ Dislike |
4.21
(9.43)
|
11.71
(20.35)
|
12.38
(23.77)
|
10.71
(18.75)
|
11.0
(20.60)
|
0.83
(2.24)
|
| DEQ High |
3.29
(6.06)
|
8.83
(16.31)
|
10.58
(21.85)
|
6.96
(18.44)
|
5.5
(10.43)
|
3.67
(9.40)
|
| DEQ More |
14.21
(25.26)
|
13.5
(25.24)
|
6.54
(13.71)
|
5.63
(12.59)
|
3.71
(7.66)
|
11.0
(25.32)
|
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 30 minutes after drink administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
43.42
(29.53)
|
76.83
(20.01)
|
38.25
(33.45)
|
21.58
(19.52)
|
17.83
(22.56)
|
18.63
(20.69)
|
| DEQ Like |
53.88
(34.49)
|
45.08
(28.43)
|
28.75
(30.05)
|
16.63
(22.89)
|
14.38
(20.78)
|
25.29
(28.76)
|
| DEQ Dislike |
15.71
(22.76)
|
43.96
(28.96)
|
25.63
(35.03)
|
17.71
(23.32)
|
16.68
(26.83)
|
15.79
(20.66)
|
| DEQ High |
30.5
(27.78)
|
50.38
(32.15)
|
31.75
(35.00)
|
12.54
(18.09)
|
11.5
(21.80)
|
12.96
(20.22)
|
| DEQ More |
42.17
(35.27)
|
24.75
(32.67)
|
17.46
(25.18)
|
10.96
(19.14)
|
10.0
(18.32)
|
18.96
(28.97)
|
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 90 minutes after drink administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
34.92
(24.75)
|
61.21
(24.02)
|
31.54
(31.41)
|
16.46
(18.97)
|
12.75
(18.74)
|
13.17
(19.05)
|
| DEQ Like |
55.67
(31.45)
|
29.92
(28.57)
|
20.08
(26.32)
|
10.42
(18.22)
|
11.38
(19.35)
|
13.25
(22.87)
|
| DEQ Dislike |
16.54
(21.60)
|
50.46
(26.47)
|
23.25
(29.72)
|
17.54
(26.16)
|
15.33
(24.85)
|
15.96
(24.91)
|
| DEQ High |
27.92
(24.57)
|
41.83
(30.74)
|
29.21
(32.78)
|
6.83
(12.47)
|
7.25
(13.50)
|
7.58
(12.65)
|
| DEQ More |
50.21
(36.06)
|
25.88
(35.11)
|
16.54
(23.69)
|
6.54
(15.33)
|
7.71
(16.59)
|
12.88
(21.88)
|
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 120 minutes after drink administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
27.08
(22.38)
|
43.92
(24.18)
|
24.08
(29.28)
|
11.92
(14.26)
|
7.96
(14.08)
|
7.88
(14.65)
|
| DEQ Like |
43.75
(36.08)
|
23.79
(25.61)
|
18
(27.26)
|
7.04
(13.90)
|
4.83
(11.49)
|
8.67
(16.86)
|
| DEQ Dislike |
11.92
(19.56)
|
44.92
(31.37)
|
19.63
(27.21)
|
13.38
(22.39)
|
11.08
(23.89)
|
8.88
(18.69)
|
| DEQ High |
18.88
(21.43)
|
29.38
(25.77)
|
21.96
(30.06)
|
5.04
(8.12)
|
5.08
(11.20)
|
4.83
(10.45)
|
| DEQ More |
45.38
(34.86)
|
17.5
(27.95)
|
9.92
(18.06)
|
3.13
(5.53)
|
6.54
(15.59)
|
9.88
(19.63)
|
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 150 minutes after drink administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
19.79
(17.72)
|
30.83
(22.52)
|
18.63
(25.28)
|
5.83
(10.72)
|
4.63
(10.48)
|
4.63
(7.80)
|
| DEQ Like |
39.5
(34.58)
|
21.33
(24.74)
|
11.71
(19.22)
|
6.74
(14.88)
|
2.42
(6.76)
|
4.96
(14.48)
|
| DEQ Dislike |
11.25
(20.64)
|
40.75
(32.31)
|
17.79
(26.78)
|
8.09
(21.80)
|
4.29
(13.84)
|
6.42
(15.69)
|
| DEQ High |
16.33
(18.68)
|
20.46
(23.70)
|
14.75
(20.27)
|
2.87
(4.48)
|
2.13
(4.83)
|
1.96
(4.56)
|
| DEQ More |
44.08
(34.63)
|
12.58
(24.39)
|
9.38
(18.95)
|
2.87
(10.55)
|
5.04
(12.75)
|
6.21
(15.19)
|
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 180 minutes after drink administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
16.13
(17.06)
|
22.21
(19.71)
|
15.67
(24.63)
|
3.5
(8.548)
|
2.08
(5.01)
|
2.54
(4.59)
|
| DEQ Like |
31.08
(34.86)
|
9.04
(14.29)
|
7.33
(15.82)
|
2.54
(11.23)
|
1.75
(7.56)
|
4.0
(12.47)
|
| DEQ Dislike |
11.54
(25.17)
|
29.5
(34.28)
|
16.13
(28.42)
|
4.25
(17.24)
|
4.29
(16.80)
|
4.63
(13.65)
|
| DEQ High |
11.67
(15.29)
|
14.13
(19.36)
|
11.79
(18.36)
|
1.63
(4.92)
|
1.25
(3.30)
|
1.04
(3.30)
|
| DEQ More |
38.38
(34.54)
|
7.0
(19.77)
|
10.04
(18.61)
|
2.46
(10.99)
|
4.04
(12.22)
|
5.04
(12.89)
|
| Title | Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration |
|---|---|
| Description | Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 210 minutes after drink administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| DEQ Feel |
11.08
(16.71)
|
12.88
(15.88)
|
5.79
(10.91)
|
2.17
(5.74)
|
0.96
(2.74)
|
1.08
(2.75)
|
| DEQ Like |
18.38
(31.38)
|
7.33
(14.62)
|
4.88
(10.41)
|
1.96
(7.04)
|
0.25
(0.74)
|
4.38
(13.73)
|
| DEQ Dislike |
8.54
(24.16)
|
22.71
(30.79)
|
6.83
(15.46)
|
7.46
(23.16)
|
1.29
(3.82)
|
4.54
(15.14)
|
| DEQ High |
6.25
(9.88)
|
9.21
(15.84)
|
4.96
(11.02)
|
0.33
(1.05)
|
0.83
(1.76)
|
0.42
(1.32)
|
| DEQ More |
32.5
(31.84)
|
4.54
(17.72)
|
8.79
(17.04)
|
2.25
(8.19)
|
3.83
(12.09)
|
6.17
(14.65)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
-0.17
(0.92)
|
0.25
(1.33)
|
-0.04
(1.16)
|
-0.25
(0.61)
|
-0.17
(1.2)
|
0.54
(0.88)
|
| ARC MBG |
-0.58
(1.44)
|
-0.29
(1.27)
|
-0.71
(1.88)
|
-0.58
(0.65)
|
-0.67
(1.46)
|
0.33
(1.37)
|
| ARC LSD |
0.13
(0.85)
|
0.33
(0.82)
|
0.38
(1.69)
|
0.13
(0.99)
|
0.08
(0.97)
|
-0.17
(0.64)
|
| ARC BG |
-0.46
(1.02)
|
-0.75
(1.67)
|
-0.79
(2.0)
|
-1.17
(1.52)
|
-0.92
(1.21)
|
0.25
(1.03)
|
| ARC PCAG |
0.58
(1.21)
|
1.29
(2.39)
|
2.92
(2.73)
|
1.96
(2.44)
|
0.92
(1.61)
|
0.42
(1.02)
|
| ARC M |
0.08
(1.06)
|
0.83
(1.81)
|
0.42
(1.32)
|
0.5
(1.25)
|
0.33
(1.05)
|
0.42
(1.18)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 30 minutes after drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
2.88
(2.80)
|
1.92
(2.64)
|
0.17
(0.96)
|
0
(0.93)
|
-0.33
(1.61)
|
0.71
(1.40)
|
| ARC MBG |
3.71
(4.59)
|
1.38
(4.79)
|
-0.54
(3.04)
|
0
(1.77)
|
-1.17
(2.75)
|
0.88
(3.26)
|
| ARC LSD |
1.13
(2.03)
|
2.63
(2.32)
|
1.54
(2.47)
|
0.33
(1.09)
|
0.29
(1.12)
|
0.13
(1.23)
|
| ARC BG |
1.63
(2.28)
|
-0.88
(3.00)
|
-1.38
(1.64)
|
-0.83
(1.31)
|
-0.96
(1.99)
|
0.04
(1.46)
|
| ARC PCAG |
-1
(1.89)
|
3.71
(4.29)
|
2.96
(3.33)
|
2.25
(3.55)
|
1.54
(3.24)
|
1.13
(2.35)
|
| ARC M |
3.21
(2.73)
|
3.42
(2.22)
|
2.04
(2.56)
|
0.42
(0.93)
|
0.29
(1.16)
|
0.96
(1.78)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 90 minutes after drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
2.96
(2.49)
|
0.29
(2.44)
|
0
(1.22)
|
-0.33
(0.76)
|
-0.58
(1.28)
|
-0.08
(1.02)
|
| ARC MBG |
3.67
(4.86)
|
-0.38
(2.45)
|
-0.83
(2.55)
|
-0.29
(0.86)
|
-1.29
(2.93)
|
-0.13
(0.95)
|
| ARC LSD |
1.08
(1.89)
|
1.79
(1.93)
|
1.42
(2.69)
|
-0.04
(0.95)
|
0.29
(1.12)
|
0.08
(0.93)
|
| ARC BG |
2.17
(2.39)
|
-2.54
(2.40)
|
-1.71
(2.03)
|
-1.29
(1.63)
|
-1.13
(1.57)
|
-0.67
(1.46)
|
| ARC PCAG |
-1.21
(2.17)
|
6.21
(2.92)
|
3.54
(3.68)
|
2.67
(2.96)
|
1.92
(3.22)
|
1.58
(1.91)
|
| ARC M |
2.63
(2.46)
|
2.25
(2.51)
|
2.04
(2.63)
|
0.42
(0.97)
|
0.13
(0.80)
|
0.29
(0.62)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 120 minutes after drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
2.17
(2.06)
|
-0.33
(1.34)
|
-0.08
(1.21)
|
-0.17
(0.70)
|
-0.71
(1.37)
|
-0.04
(0.86)
|
| ARC MBG |
3.33
(4.35)
|
-1.13
(2.13)
|
-0.96
(2.60)
|
-0.125
(0.85)
|
-1.29
(2.97)
|
-0.08
(0.65)
|
| ARC LSD |
0.38
(1.93)
|
0.79
(1.28)
|
1
(2.83)
|
-0.13
(1.15)
|
0.04
(1.16)
|
-0.08
(0.93)
|
| ARC BG |
1.67
(2.12)
|
-2.04
(1.73)
|
-1.54
(1.64)
|
-1
(1.35)
|
-0.83
(1.55)
|
-0.38
(1.58)
|
| ARC PCAG |
-1.08
(2.02)
|
5.46
(2.93)
|
2.88
(3.49)
|
1.71
(2.65)
|
1.63
(2.76)
|
1.08
(1.98)
|
| ARC M |
1.83
(2.46)
|
1.08
(1.56)
|
1.42
(2.04)
|
0.25
(0.85)
|
-0.04
(0.86)
|
0.17
(0.56)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 150 minutes after drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
2.29
(2.61)
|
-0.54
(1.14)
|
-0.17
(1.63)
|
-0.13
(0.69)
|
-0.54
(1.47)
|
-0.08
(0.83)
|
| ARC MBG |
2.96
(4.39)
|
-1.54
(1.96)
|
-0.96
(2.39)
|
0.13
(0.76)
|
-1.25
(2.88)
|
-0.08
(0.88)
|
| ARC LSD |
0.5
(1.59)
|
0.79
(1.35)
|
0.58
(2.22)
|
0.09
(1.08)
|
-0.13
(1.03)
|
-0.17
(0.82)
|
| ARC BG |
1.75
(2.31)
|
-2.04
(1.65)
|
-1.29
(1.86)
|
-0.43
(1.31)
|
-0.67
(1.24)
|
-0.42
(1.28)
|
| ARC PCAG |
-1
(1.64)
|
5.46
(2.95)
|
2.58
(3.16)
|
0.65
(2.17)
|
1.58
(2.96)
|
0.79
(1.79)
|
| ARC M |
1.54
(1.91)
|
0.75
(1.33)
|
0.83
(1.83)
|
0.22
(0.74)
|
-0.21
(0.78)
|
0.08
(0.41)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 180 minutes after drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
1.58
(2.26)
|
-0.75
(1.19)
|
-0.21
(1.44)
|
-0.04
(0.91)
|
-0.33
(1.69)
|
-0.17
(1.13)
|
| ARC MBG |
1.92
(4.03)
|
-1.29
(1.88)
|
-0.67
(2.37)
|
0.33
(1.24)
|
-1.08
(3.01)
|
-0.17
(0.82)
|
| ARC LSD |
0.46
(1.91)
|
0.54
(1.02)
|
0.54
(1.82)
|
0.04
(1.04)
|
-0.04
(0.81)
|
0.04
(0.95)
|
| ARC BG |
1.13
(2.15)
|
-1.5
(1.47)
|
-1.29
(1.78)
|
-0.33
(1.13)
|
-0.38
(1.41)
|
-0.29
(1.20)
|
| ARC PCAG |
-0.46
(1.93)
|
3.63
(3.01)
|
2.13
(3.43)
|
0.21
(2.50)
|
0.71
(2.73)
|
0.42
(1.59)
|
| ARC M |
1.21
(1.59)
|
0.08
(1.02)
|
0.71
(1.94)
|
0.13
(0.68)
|
-0.13
(0.74)
|
-0.08
(0.28)
|
| Title | Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration |
|---|---|
| Description | Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration. |
| Time Frame | Measured 15 minutes prior to capsule administration and 210 minutes after drink administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed all sessions |
| Arm/Group Title | AMP Arm | ALC Arm | THC Arm | AMP Placebo Arm | ALC Placebo Arm | THC Placebo Arm |
|---|---|---|---|---|---|---|
| Arm/Group Description | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage. | All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 24 |
| ARC A |
1.0
(1.93)
|
-0.71
(1.20)
|
-0.46
(1.06)
|
-0.17
(0.82)
|
-0.54
(1.50)
|
0.08
(1.21)
|
| ARC MBG |
1.38
(3.31)
|
-1.17
(2.08)
|
-0.88
(1.92)
|
0.13
(1.15)
|
-0.79
(2.95)
|
0.04
(0.86)
|
| ARC LSD |
0.63
(1.79)
|
0.33
(0.92)
|
0.54
(1.22)
|
0.25
(0.90)
|
1.67
(0.87)
|
0.04
(1.04)
|
| ARC BG |
0.83
(1.61)
|
-1.25
(1.39)
|
-0.83
(1.40)
|
-0.17
(0.82)
|
-0.38
(1.06)
|
-0.13
(1.48)
|
| ARC PCAG |
-0.29
(2.10)
|
3.17
(3.17)
|
1.04
(1.76)
|
-0.29
(1.43)
|
0.21
(2.55)
|
0.13
(1.68)
|
| ARC M |
0.96
(1.97)
|
0.08
(0.97)
|
0.21
(0.72)
|
0
(0.42)
|
-0.17
(0.70)
|
-0.08
(0.28)
|
Adverse Events
| Time Frame | During study only (1 Day) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Healthy Adult Volunteers | |
| Arm/Group Description | 24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo. | |
All Cause Mortality |
||
| Healthy Adult Volunteers | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Healthy Adult Volunteers | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Healthy Adult Volunteers | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/28 (3.6%) | |
| Gastrointestinal disorders | ||
| vomiting from alcohol dose | 1/28 (3.6%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Harriet de Wit |
|---|---|
| Organization | University of Chicago |
| Phone | 773-702-1537 |
| hdew@uchicago.edu |
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT02485158
Other Study ID Numbers:
- IRB13-0534
First Posted:
Jun 30, 2015
Last Update Posted:
Nov 29, 2016
Last Verified:
Oct 1, 2016