Behavioral Effects of Pregabalin and Cannabis
Sponsor
Joshua A. Lile, Ph.D. (Other)
Overall Status
Completed
CT.gov ID
NCT01511640
Collaborator
(none)
30
1
4
37.4
0.8
Study Details
Study Description
Brief Summary
Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Behavioral Effects of Drugs (Outpatient)(43)
Actual Study Start Date
:
Feb 1, 2017
Actual Primary Completion Date
:
Mar 15, 2020
Actual Study Completion Date
:
Mar 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pregabalin 1 Dose 1 |
Drug: Pregabalin
pregabalin 2x daily for duration of study
|
| Placebo Comparator: Placebo 1 Placebo 1 |
Drug: Placebo
placebo 2x daily for duration of study
|
| Experimental: Pregabalin 2 Dose 2 |
Drug: Pregabalin
pregabalin 2x daily for duration of study
|
| Placebo Comparator: Placebo 2 Placebo 2 |
Drug: Placebo
placebo 2x daily for duration of study
|
Outcome Measures
Primary Outcome Measures
- Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions [9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.]
The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
regular cannabis use
-
good health other than cannabis use
-
willingness to attempt abstinence
-
effective form of birth control in female subjects
-
available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each
-
located in close proximity to University of Kentucky
Exclusion Criteria:
-
medical screening outcomes outside normal ranges or deemed clinically insignificant
-
medical history that would contraindicate pregabalin administration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratory of Human Behavioral Pharmacology | Lexington | Kentucky | United States | 40536-0086 |
Sponsors and Collaborators
- Joshua A. Lile, Ph.D.
Investigators
- Principal Investigator: Joshua A. Lile, Ph.D., University of Kentucky
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Joshua A. Lile, Ph.D.,
Associate Professor of Behavioral Science,
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01511640
Other Study ID Numbers:
- R01DA036550
First Posted:
Jan 18, 2012
Last Update Posted:
Sep 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joshua A. Lile, Ph.D.,
Associate Professor of Behavioral Science,
University of Kentucky
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 300 mg/Day Pregabalin, Then Placebo | Placebo, Then 300 mg/Day Pregabalin | 450 mg/Day Pregabalin, Then Placebo | Placebo, Then 450 mg/Day Pregabalin |
|---|---|---|---|---|
| Arm/Group Description | 300 mg/day Pregabalin, then Placebo 150 mg then 0 mg 2x daily for duration of treatment phase | Placebo, then 300 mg/day Pregabalin 0 mg then 150 mg 2x daily for duration of treatment phase | 450 mg/day Pregabalin, then Placebo 225 mg then 0 mg 2x daily for duration of treatment phase | Placebo, then 450 mg/day Pregabalin 0 mg then 225 mg 2x daily for duration of treatment phase |
| Period Title: First Intervention (11-15 Days) | ||||
| STARTED | 7 | 8 | 7 | 8 |
| COMPLETED | 5 | 8 | 7 | 7 |
| NOT COMPLETED | 2 | 0 | 0 | 1 |
| Period Title: First Intervention (11-15 Days) | ||||
| STARTED | 5 | 8 | 7 | 7 |
| COMPLETED | 5 | 8 | 7 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 1 |
| Period Title: First Intervention (11-15 Days) | ||||
| STARTED | 5 | 8 | 7 | 6 |
| COMPLETED | 4 | 7 | 7 | 6 |
| NOT COMPLETED | 1 | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 300 mg/Day Pregabalin, Then Placebo | Placebo, Then 300 mg/Day Pregabalin | 450 mg/Day Pregabalin, Then Placebo | Placebo, Then 450 mg/Day Pregabalin | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 300 mg/day Pregabalin, then Placebo 150 mg then 0 mg 2x daily for duration of treatment phase | Placebo, then 300 mg/day Pregabalin 0 mg then 150 mg 2x daily for duration of treatment phase | 450 mg/day Pregabalin, then Placebo 225 mg then 0 mg 2x daily for duration of treatment phase | Placebo, then 450 mg/day Pregabalin 0 mg then 225 mg 2x daily for duration of treatment phase | Total of all reporting groups |
| Overall Participants | 7 | 8 | 7 | 8 | 30 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
7
100%
|
8
100%
|
7
100%
|
8
100%
|
30
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
14.3%
|
1
12.5%
|
2
28.6%
|
1
12.5%
|
5
16.7%
|
| Male |
6
85.7%
|
7
87.5%
|
5
71.4%
|
7
87.5%
|
25
83.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
1
14.3%
|
0
0%
|
0
0%
|
1
12.5%
|
2
6.7%
|
| Not Hispanic or Latino |
6
85.7%
|
8
100%
|
6
85.7%
|
7
87.5%
|
27
90%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
1
3.3%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
14.3%
|
3
37.5%
|
1
14.3%
|
1
12.5%
|
6
20%
|
| White |
6
85.7%
|
5
62.5%
|
3
42.9%
|
7
87.5%
|
21
70%
|
| More than one race |
0
0%
|
0
0%
|
2
28.6%
|
0
0%
|
2
6.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
1
3.3%
|
Outcome Measures
| Title | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions |
|---|---|
| Description | The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance. |
| Time Frame | 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 300 mg/Day Pregabalin | 0 mg/Day Pregabalin (Placebo 1) | 450 mg/Day Pregabalin | 0 mg/Day Pregabalin (Placebo 2) |
|---|---|---|---|---|
| Arm/Group Description | Cannabis choice during 300 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 300 mg/day | Cannabis choice during 0 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 0 mg/day (comparator for 300 mg/day) | Cannabis choice during 450 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 450 mg/day | Cannabis choice during 0 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 0 mg/day (comparator for 450 mg/day) |
| Measure Participants | 12 | 12 | 13 | 14 |
| 0% placebo Cannabis |
2.00
(0.92)
|
2.67
(0.92)
|
3.60
(1.15)
|
4.00
(0.88)
|
| 5.9% active Cannabis |
5.75
(0.95)
|
5.67
(0.77)
|
5.40
(0.85)
|
4.80
(0.76)
|
Adverse Events
| Time Frame | 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 300 mg/Day Pregabalin | 0 mg/Day Pregabalin (Placebo 1) | 450 mg/Day PregabalinPregabalin | 0 mg/Day Pregabalin (Placebo 2) | ||||
| Arm/Group Description | Cannabis choice during 300 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis | Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 300 mg/day group) Placebo (0% THC) and Active (5.9% THC) Cannabis | Cannabis choice during 450 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis | Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 450 mg/day group) Placebo (0% THC) and Active (5.9% THC) Cannabis | ||||
All Cause Mortality |
||||||||
| 300 mg/Day Pregabalin | 0 mg/Day Pregabalin (Placebo 1) | 450 mg/Day PregabalinPregabalin | 0 mg/Day Pregabalin (Placebo 2) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/13 (0%) | 0/13 (0%) | 0/14 (0%) | ||||
Serious Adverse Events |
||||||||
| 300 mg/Day Pregabalin | 0 mg/Day Pregabalin (Placebo 1) | 450 mg/Day PregabalinPregabalin | 0 mg/Day Pregabalin (Placebo 2) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/13 (0%) | 0/13 (0%) | 0/14 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 300 mg/Day Pregabalin | 0 mg/Day Pregabalin (Placebo 1) | 450 mg/Day PregabalinPregabalin | 0 mg/Day Pregabalin (Placebo 2) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/12 (8.3%) | 1/13 (7.7%) | 0/13 (0%) | 0/14 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| nausea/vomiting | 0/12 (0%) | 0 | 1/13 (7.7%) | 1 | 1/13 (7.7%) | 1 | 1/14 (7.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| chest pain | 1/12 (8.3%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
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 | Joshua Lile, Ph.D., Professor |
|---|---|
| Organization | University of Kentucky College of Medicine |
| Phone | 8593236034 |
| jalile2@uky.edu |
Responsible Party:
Joshua A. Lile, Ph.D.,
Associate Professor of Behavioral Science,
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01511640
Other Study ID Numbers:
- R01DA036550
First Posted:
Jan 18, 2012
Last Update Posted:
Sep 10, 2021
Last Verified:
Aug 1, 2021