Trial Outcomes & Findings for Behavioral Effects of Pregabalin and Cannabis (NCT NCT01511640)
NCT ID: NCT01511640
Last Updated: 2021-09-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
30 participants
Primary outcome timeframe
9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.
Results posted on
2021-09-10
Participant Flow
Participant milestones
| Measure |
300 mg/Day Pregabalin, Then Placebo
300 mg/day Pregabalin, then Placebo
150 mg then 0 mg 2x daily for duration of treatment phase
|
Placebo, Then 300 mg/Day Pregabalin
Placebo, then 300 mg/day Pregabalin
0 mg then 150 mg 2x daily for duration of treatment phase
|
450 mg/Day Pregabalin, Then Placebo
450 mg/day Pregabalin, then Placebo
225 mg then 0 mg 2x daily for duration of treatment phase
|
Placebo, Then 450 mg/Day Pregabalin
Placebo, then 450 mg/day Pregabalin
0 mg then 225 mg 2x daily for duration of treatment phase
|
|---|---|---|---|---|
|
First Intervention (11-15 Days)
STARTED
|
7
|
8
|
7
|
8
|
|
First Intervention (11-15 Days)
COMPLETED
|
5
|
8
|
7
|
7
|
|
First Intervention (11-15 Days)
NOT COMPLETED
|
2
|
0
|
0
|
1
|
|
Washout (6-10 Days)
STARTED
|
5
|
8
|
7
|
7
|
|
Washout (6-10 Days)
COMPLETED
|
5
|
8
|
7
|
6
|
|
Washout (6-10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Third Intervention (11-15 Days)
STARTED
|
5
|
8
|
7
|
6
|
|
Third Intervention (11-15 Days)
COMPLETED
|
4
|
7
|
7
|
6
|
|
Third Intervention (11-15 Days)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Effects of Pregabalin and Cannabis
Baseline characteristics by cohort
| Measure |
300 mg/Day Pregabalin, Then Placebo
n=7 Participants
300 mg/day Pregabalin, then Placebo
150 mg then 0 mg 2x daily for duration of treatment phase
|
Placebo, Then 300 mg/Day Pregabalin
n=8 Participants
Placebo, then 300 mg/day Pregabalin
0 mg then 150 mg 2x daily for duration of treatment phase
|
450 mg/Day Pregabalin, Then Placebo
n=7 Participants
450 mg/day Pregabalin, then Placebo
225 mg then 0 mg 2x daily for duration of treatment phase
|
Placebo, Then 450 mg/Day Pregabalin
n=8 Participants
Placebo, then 450 mg/day Pregabalin
0 mg then 225 mg 2x daily for duration of treatment phase
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
300 mg/Day Pregabalin
n=12 Participants
Cannabis choice during 300 mg/day Pregabalin maintenance
Placebo (0% THC) and Active (5.9% THC) Cannabis
Pregabalin 300 mg/day
|
0 mg/Day Pregabalin (Placebo 1)
n=12 Participants
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)
|
450 mg/Day Pregabalin
n=13 Participants
Cannabis choice during 450 mg/day Pregabalin maintenance
Placebo (0% THC) and Active (5.9% THC) Cannabis
Pregabalin 450 mg/day
|
0 mg/Day Pregabalin (Placebo 2)
n=14 Participants
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)
|
|---|---|---|---|---|
|
Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
0% placebo Cannabis
|
2.00 Cannabis puffs
Standard Error 0.92
|
2.67 Cannabis puffs
Standard Error 0.92
|
3.60 Cannabis puffs
Standard Error 1.15
|
4.00 Cannabis puffs
Standard Error 0.88
|
|
Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
5.9% active Cannabis
|
5.75 Cannabis puffs
Standard Error 0.95
|
5.67 Cannabis puffs
Standard Error 0.77
|
5.40 Cannabis puffs
Standard Error 0.85
|
4.80 Cannabis puffs
Standard Error 0.76
|
Adverse Events
300 mg/Day Pregabalin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0 mg/Day Pregabalin (Placebo 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
450 mg/Day PregabalinPregabalin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0 mg/Day Pregabalin (Placebo 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
300 mg/Day Pregabalin
n=12 participants at risk
Cannabis choice during 300 mg/day Pregabalin maintenance
Placebo (0% THC) and Active (5.9% THC) Cannabis
|
0 mg/Day Pregabalin (Placebo 1)
n=13 participants at risk
Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 300 mg/day group)
Placebo (0% THC) and Active (5.9% THC) Cannabis
|
450 mg/Day PregabalinPregabalin
n=13 participants at risk
Cannabis choice during 450 mg/day Pregabalin maintenance
Placebo (0% THC) and Active (5.9% THC) Cannabis
|
0 mg/Day Pregabalin (Placebo 2)
n=14 participants at risk
Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 450 mg/day group)
Placebo (0% THC) and Active (5.9% THC) Cannabis
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea/vomiting
|
0.00%
0/12 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
7.7%
1/13 • Number of events 1 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
0.00%
0/13 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
0.00%
0/14 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
8.3%
1/12 • Number of events 1 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
0.00%
0/13 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
0.00%
0/13 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
0.00%
0/14 • 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
|
Additional Information
Joshua Lile, Ph.D., Professor
University of Kentucky College of Medicine
Phone: 8593236034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place