Marijuana Smoking
Conditions
Keywords
quetiapine, smoked marijuana, marijuana use
Brief summary
The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.
Detailed description
The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.
Interventions
DRUGMarijuana
0,6.2% THC
DRUGQuetiapine
200 mg/day
DRUGPlacebo oral capsule
Sponsors
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per week for the past 4 weeks * Able to perform study procedures * 21-45 years of age * Women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, IUD) * Normal body weight
Exclusion criteria
* Current, repeated illicit drug use (other than marijuana) * Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant abnormalities) * History of heart disease or current conduction system disease as indicated by QRS duration \> 0.11 * Request for drug treatment * Current parole or probation * Pregnancy or current lactation * Recent history of significant violent behavior * Major current Axis I psychopathology (major depressive disorder, bipolar disorder, suicide risk, schizophrenia) * Current use of any prescription or over-the-counter medication * Prior allergic or otherwise serious adverse reaction to quetiapine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase | Days 1-3 (Baseline) and Days 6-8 (Relapse Phase) | This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value. |
Countries
United States
Participant flow
Pre-assignment details
14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.
Participants by arm
| Arm | Count |
|---|---|
| Overall Number of Baseline Participants | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intervention 1 (8 Days) | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Overall Number of Baseline Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.
Time frame: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine, Marijuana | Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase | 2.5 Puffs | Standard Error 0.6 |
| Placebo, Marijuana | Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase | 1.5 Puffs | Standard Error 1.1 |