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Behavioral Effects of Pregabalin and Cannabis

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ClinicalTrials.gov Identifier: NCT01511640
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : September 10, 2021
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Cannabis-use Disorders
Interventions Drug: Pregabalin
Drug: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
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
Hide 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: Washout (6-10 Days)
Started 5 8 7 7
Completed 5 8 7 6
Not Completed 0 0 0 1
Period Title: Third Intervention (11-15 Days)
Started 5 8 7 6
Completed 4 7 7 6
Not Completed 1 1 0 0
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
Hide 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 Number of Baseline Participants 7 8 7 8 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 7 participants 8 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
8
 100.0%
7
 100.0%
8
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 7 participants 8 participants 30 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 7 participants 8 participants 30 participants
Hispanic or Latino
1
  14.3%
0
   0.0%
0
   0.0%
1
  12.5%
2
   6.7%
Not Hispanic or Latino
6
  85.7%
8
 100.0%
6
  85.7%
7
  87.5%
27
  90.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 7 participants 8 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
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
   0.0%
0
   0.0%
Black or African American
1
  14.3%
3
  37.5%
1
  14.3%
1
  12.5%
6
  20.0%
White
6
  85.7%
5
  62.5%
3
  42.9%
7
  87.5%
21
  70.0%
More than one race
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
2
   6.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
   3.3%
1.Primary Outcome
Title Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
Hide 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.
Hide Outcome Measure Data
Hide 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)
Hide 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)
Overall Number of Participants Analyzed 12 12 13 14
Mean (Standard Error)
Unit of Measure: Cannabis puffs
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)
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 [Not Specified]
 
Arm/Group Title 300 mg/Day Pregabalin 0 mg/Day Pregabalin (Placebo 1) 450 mg/Day PregabalinPregabalin 0 mg/Day Pregabalin (Placebo 2)
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/13 (0.00%)      0/13 (0.00%)      0/14 (0.00%)    
Hide 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 (0.00%)      0/13 (0.00%)      0/13 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (8.33%)      1/13 (7.69%)      0/13 (0.00%)      0/14 (0.00%)    
Gastrointestinal disorders         
nausea/vomiting * [1]  0/12 (0.00%)  0 1/13 (7.69%)  1 /13  /14 
Musculoskeletal and connective tissue disorders         
chest pain * [2]  1/12 (8.33%)  1 0/13 (0.00%)  0 /13  /14 
*
Indicates events were collected by non-systematic assessment
[1]
associated with consumption of spoiled food
[2]
associated with injury sustained during excessive use of alcohol
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Joshua Lile, Ph.D., Professor
Organization: University of Kentucky College of Medicine
Phone: 8593236034
EMail: jalile2@uky.edu
Layout table for additonal information
Responsible Party: Joshua A. Lile, Ph.D., University of Kentucky
ClinicalTrials.gov Identifier: NCT01511640    
Other Study ID Numbers: R01DA036550 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2012
First Posted: January 18, 2012
Results First Submitted: April 13, 2021
Results First Posted: September 10, 2021
Last Update Posted: September 10, 2021