Caffeine and Cocaine
Study Details
Study Description
Brief Summary
This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Specific Aims:
Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects.
Hypotheses related to Aim 1:
-
Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.
-
Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Caffeine 150 mg Caffeine 150 mg |
Drug: Caffeine 150 MG
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Other Names:
|
Placebo Comparator: 2 Placebo Placebo |
Drug: Placebo
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
|
Experimental: 3 Amphetamine Amphetamine |
Drug: Amphetamine
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
|
Experimental: 4 Caffeine 300 mg Caffeine 300 mg |
Drug: Caffeine 300 MG
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Visual Analog Scale Subjective Rating of Drug Effects [Immediately after dose]
Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.
- Systolic and Diastolic Blood Pressure [Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours]
Sitting Blood Pressure
- Heart Rate [Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours]
Sitting heart rate
- Addiction Research Center Inventory Subjective Rating of Drug Effects [Immediately after dose]
Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items. Includes the following subscales: Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy)
- Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects [Immediately after dose]
Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.
Secondary Outcome Measures
- Probabalistic Feedback Selection Task [75 minutes after dose]
Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.
- Saliva Caffeine and Paraxanthine Levels [30 minutes prior to dose, 30/90/150 minutes post dose.]
Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects. Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls
-
At least one cocaine positive urine during screening.
-
Current regular consumption of caffeine.
-
Female subjects: a negative pregnancy test.
Exclusion Criteria:
-
Current or past DSM-IV Axis I disorder other than substance abuse/ dependence
-
Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine
-
Substance dependence other than cocaine within the last 3 months.
-
Positive breath alcohol.
-
Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing
-
For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.
-
Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.
-
HIV positive.
-
I.Q. below 70.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The University of Texas Health Science Center, Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Institute on Drug Abuse (NIDA)
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Frederick G Moeller, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DA09262
- P50DA009262
- DPMCDA
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cocaine Users | Control Participants |
---|---|---|
Arm/Group Description | Cocaine users were allocated to different sequence orders for the 5 interventions Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | Control participants were allocated to different sequence orders for the 5 interventions Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion |
Period Title: Overall Study | ||
STARTED | 13 | 10 |
COMPLETED | 13 | 10 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Cocaine Users | Control Participants | Total |
---|---|---|---|
Arm/Group Description | Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | Total of all reporting groups |
Overall Participants | 13 | 10 | 23 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
13
100%
|
10
100%
|
23
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
23.1%
|
5
50%
|
8
34.8%
|
Male |
10
76.9%
|
5
50%
|
15
65.2%
|
Region of Enrollment (participants) [Number] | |||
United States |
13
100%
|
10
100%
|
23
100%
|
Outcome Measures
Title | Visual Analog Scale Subjective Rating of Drug Effects |
---|---|
Description | Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated. |
Time Frame | Immediately after dose |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20 mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300 mg | Amphetamine 20 mg |
Measure Participants | 23 | 23 | 23 | 23 |
Elation: Control (N=10) |
8.65
(5.33)
|
9.85
(5.32)
|
13.65
(6.1)
|
10.43
(4.48)
|
Elation: Cocaine (N=13) |
25.99
(6.01)
|
32.54
(7.62)
|
21.65
(5.68)
|
25.71
(6.42)
|
Anxious: Control (N=10) |
10.15
(5.31)
|
10.45
(5.69)
|
8.50
(4.91)
|
11.68
(4.62)
|
Anxious: Cocaine (N=13) |
19.64
(6.17)
|
21.35
(6.01)
|
25.27
(7.12)
|
21.71
(5.43)
|
Vigor: Control (N=10) |
8.25
(2.06)
|
8.50
(1.92)
|
9.78
(1.98)
|
8.28
(2.01)
|
Vigor: Cocaine (N=13) |
10.42
(1.54)
|
10.85
(1.59)
|
9.27
(1.60)
|
10.31
(1.33)
|
Tension: Control (N=10) |
1.05
(0.38)
|
1.60
(0.53)
|
1.62
(0.60)
|
1.53
(0.48)
|
Tension: Cocaine (N=13) |
1.63
(0.62)
|
0.96
(0.57)
|
2.38
(0.94)
|
1.88
(0.61)
|
Fatigue: Control (N=10) |
3.85
(1.37)
|
3.00
(1.48)
|
3.44
(1.64)
|
3.60
(1.07)
|
Fatigue: Cocaine (N=13) |
0.68
(0.32)
|
0.54
(0.25)
|
1.69
(0.71)
|
1.17
(0.36)
|
Depression: Control (N=10) |
0.10
(0.10)
|
0.10
(0.10)
|
0.41
(0.30)
|
0.10
(0.06)
|
Depression: Cocaine (N=13) |
1.05
(0.54)
|
0.62
(0.47)
|
1.96
(1.12)
|
1.10
(0.51)
|
Title | Systolic and Diastolic Blood Pressure |
---|---|
Description | Sitting Blood Pressure |
Time Frame | Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300mg | Amphetamine 20mg |
Measure Participants | 23 | 23 | 23 | 23 |
SBP Control (N=10) |
115.64
(3.41)
|
115.9
(4.07)
|
117.36
(4.2)
|
119.27
(2.13)
|
SBP Cocaine (N=13) |
120.18
(1.40)
|
122.10
(1.81)
|
123.84
(2.18)
|
120.30
(1.58)
|
DBP Control (N=10) |
74.82
(2.78)
|
75.33
(2.72)
|
77.94
(1.42)
|
77.83
(1.45)
|
DBP Cocaine (N=13) |
79.66
(3.01)
|
79.98
(1.79)
|
82.81
(1.74)
|
78.16
(1.56)
|
Title | Heart Rate |
---|---|
Description | Sitting heart rate |
Time Frame | Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300mg | Amphetamine 20mg |
Measure Participants | 23 | 23 | 23 | 23 |
Control (N=10) |
66.10
(1.88)
|
62.47
(2.09)
|
61.33
(1.67)
|
65.55
(1.23)
|
Cocaine (N=13) |
63.08
(2.11)
|
62.60
(3.00)
|
61.57
(1.40)
|
63.51
(2.99)
|
Title | Addiction Research Center Inventory Subjective Rating of Drug Effects |
---|---|
Description | Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items. Includes the following subscales: Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy) |
Time Frame | Immediately after dose |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20 mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300 mg | Amphetamine 20 mg |
Measure Participants | 23 | 23 | 23 | 23 |
PCAG: Control (N=10) |
3.87
(0.82)
|
3.62
(0.83)
|
3.52
(0.79)
|
3.64
(0.71)
|
PCAG: Cocaine (N=13) |
1.95
(0.58)
|
1.83
(0.68)
|
2.95
(0.82)
|
2.43
(0.67)
|
A: Control (N=10) |
3.20
(0.51)
|
3.60
(0.68)
|
3.80
(0.59)
|
3.22
(0.38)
|
A: Cocaine (N=13) |
3.30
(0.51)
|
3.39
(0.54)
|
3.19
(0.44)
|
3.69
(0.45)
|
BG: Control (N=10) |
6.00
(0.39)
|
6.35
(0.56)
|
6.05
(0.57)
|
5.83
(0.36)
|
BG: Cocaine (N=13) |
5.69
(0.34)
|
5.77
(0.37)
|
5.07
(0.61)
|
5.57
(0.51)
|
MGB: Control (N=10) |
4.09
(1.26)
|
4.34
(1.31)
|
5.14
(1.37)
|
4.04
(1.28)
|
MGB: Cocaine (N=13) |
5.29
(1.13)
|
5.62
(1.23)
|
4.31
(0.96)
|
5.18
(1.00)
|
LSD: Control (N=10) |
1.78
(0.44)
|
2.43
(0.56)
|
1.23
(0.41)
|
1.70
(0.41)
|
LSD: Cocaine (N=13) |
0.89
(0.47)
|
0.48
(0.49)
|
1.05
(0.49)
|
0.98
(0.45)
|
Title | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects |
---|---|
Description | Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale. |
Time Frame | Immediately after dose |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20 mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300 mg | Amphetamine 20 mg |
Measure Participants | 23 | 23 | 23 | 23 |
Feel effects:Control (N=10) |
16.75
(7.58)
|
20.25
(6.31)
|
9.45
(4.97)
|
11.37
(4.93)
|
Feel effects:Cocaine (N=13) |
17.30
(5.80)
|
20.73
(5.95)
|
17.62
(5.91)
|
18.68
(6.08)
|
Like effects:Control (N=10) |
39.92
(6.82)
|
35.62
(6.89)
|
52.17
(6.95)
|
42.25
(5.74)
|
Like effects:Cocaine (N=13) |
37.18
(9.74)
|
39.94
(10.55)
|
43.75
(7.21)
|
32.04
(8.63)
|
High:Control (N=10) |
10.77
(5.23)
|
12.17
(5.59)
|
7.17
(4.16)
|
7.17
(3.95)
|
High:Cocaine (N=13) |
14.35
(5.45)
|
16.14
(5.67)
|
15.87
(5.78)
|
14.64
(5.44)
|
Like more:Control (N=10) |
25.77
(7.20)
|
25.62
(6.54)
|
32.92
(7.01)
|
25.65
(6.08)
|
Like more:Cocaine (N=13) |
25.96
(9.18)
|
25.68
(8.99)
|
28.71
(8.48)
|
26.16
(8.69)
|
Title | Probabalistic Feedback Selection Task |
---|---|
Description | Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy. |
Time Frame | 75 minutes after dose |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300mg | Amphetamine 20mg |
Measure Participants | 23 | 23 | 23 | 23 |
Control (N=10) |
0.56
(0.02)
|
0.55
(0.03)
|
0.56
(0.02)
|
0.61
(0.02)
|
Cocaine (N=13) |
0.54
(0.01)
|
0.56
(0.02)
|
0.58
(0.02)
|
0.56
(0.02)
|
Title | Saliva Caffeine and Paraxanthine Levels |
---|---|
Description | Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects. Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls. |
Time Frame | 30 minutes prior to dose, 30/90/150 minutes post dose. |
Outcome Measure Data
Analysis Population Description |
---|
Assessment was not performed for amphetamine intervention |
Arm/Group Title | Placebo | Caffeine 150 Mg | Caffeine 300 mg | Amphetamine 20mg |
---|---|---|---|---|
Arm/Group Description | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 150 MG of Caffeine | Caffeine 300mg | Amphetamine 20mg |
Measure Participants | 21 | 21 | 21 | 0 |
Caffeine -30 min Control (N=10) |
1000
(490)
|
510
(470)
|
335
(110)
|
|
Caffeine 30 min Control (N=10) |
983
(440)
|
2715
(1110)
|
2895
(998)
|
|
Caffeine 90 min Control (N=10) |
984
(445)
|
2225
(995)
|
3510
(1001)
|
|
Caffeine 150 min Control (N=10) |
984
(601)
|
1910
(898)
|
3270
(901)
|
|
Caffeine -30 min Cocaine (N=11) |
990
(920)
|
998
(820)
|
1201
(997)
|
|
Caffeine 30 min Cocaine (N=11) |
780
(510)
|
2125
(1001)
|
3510
(1220)
|
|
Caffeine 90 min Cocaine (N=11) |
625
(410)
|
2077
(874)
|
3720
(911)
|
|
Caffeine 150 min Cocaine (N=11) |
510
(322)
|
1909
(605)
|
3205
(697)
|
|
Parathanxine -30 min Control (N=10) |
440
(155)
|
274
(140)
|
198
(92)
|
|
Parathanxine 30 min Control (N=10) |
410
(240)
|
301
(238)
|
202
(101)
|
|
Parathanxine 90 min Control (N=10) |
411
(219)
|
402
(155)
|
397
(110)
|
|
Parathanxine 150 min Control (N=10) |
410
(143)
|
411
(145)
|
462
(215)
|
|
Parathanxine -30 min Cocaine (N=11) |
334
(205)
|
401
(197)
|
408
(240)
|
|
Parathanxine 30 min Cocaine (N=11) |
320
(275)
|
465
(185)
|
656
(280)
|
|
Parathanxine 90 min Cocaine (N=11) |
321
(248)
|
601
(233)
|
985
(245)
|
|
Parathanxine 150 min Cocaine (N=11) |
296
(252)
|
605
(247)
|
1014
(255)
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | 1 Caffeine | 2 Placebo | 3 Amphetamine | |||
Arm/Group Description | Caffeine Caffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | Placebo Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | |||
All Cause Mortality |
||||||
1 Caffeine | 2 Placebo | 3 Amphetamine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
1 Caffeine | 2 Placebo | 3 Amphetamine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
1 Caffeine | 2 Placebo | 3 Amphetamine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
Limitations/Caveats
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 | F. Gerard Moeller |
---|---|
Organization | Virginia Commonwealth University |
Phone | 804-828-4134 |
fgmoeller@vcu.edu |
- DA09262
- P50DA009262
- DPMCDA