Cannabis-use Disorders
Conditions
Keywords
marijuana, addiction, treatment, pharmacotherapy, cannabinoid
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.
Interventions
DRUGPregabalin
pregabalin 2x daily for duration of study
DRUGPlacebo
placebo 2x daily for duration of study
Sponsors
Joshua A. Lile, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 300 mg/Day Pregabalin, Then Placebo 300 mg/day Pregabalin, then Placebo
150 mg then 0 mg 2x daily for duration of treatment phase | 7 |
| Placebo, Then 300 mg/Day Pregabalin Placebo, then 300 mg/day Pregabalin
0 mg then 150 mg 2x daily for duration of treatment phase | 8 |
| 450 mg/Day Pregabalin, Then Placebo 450 mg/day Pregabalin, then Placebo
225 mg then 0 mg 2x daily for duration of treatment phase | 7 |
| Placebo, Then 450 mg/Day Pregabalin Placebo, then 450 mg/day Pregabalin
0 mg then 225 mg 2x daily for duration of treatment phase | 8 |
| Total | 30 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 8 Participants | 6 Participants | 7 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 5 Participants | 3 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 5 Participants | 7 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 1 / 12 | 1 / 13 | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 14 |
Outcome results
Primary
Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 300 mg/Day Pregabalin | 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 |
| 300 mg/Day Pregabalin | 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 |
| 0 mg/Day Pregabalin (Placebo 1) | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0% placebo Cannabis | 2.67 Cannabis puffs | Standard Error 0.92 |
| 0 mg/Day Pregabalin (Placebo 1) | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 5.9% active Cannabis | 5.67 Cannabis puffs | Standard Error 0.77 |
| 450 mg/Day Pregabalin | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 5.9% active Cannabis | 5.40 Cannabis puffs | Standard Error 0.85 |
| 450 mg/Day Pregabalin | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0% placebo Cannabis | 3.60 Cannabis puffs | Standard Error 1.15 |
| 0 mg/Day Pregabalin (Placebo 2) | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0% placebo Cannabis | 4.00 Cannabis puffs | Standard Error 0.88 |
| 0 mg/Day Pregabalin (Placebo 2) | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 5.9% active Cannabis | 4.80 Cannabis puffs | Standard Error 0.76 |