Effect of Quetiapine on Marijuana Withdrawal and Relapse

Study Overview
=================
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.

Official Title
-----------------
Effect of Quetiapine on Marijuana Withdrawal and Relapse

Conditions
-----------------
Marijuana Smoking

Intervention / Treatment
-----------------
* Drug: Marijuana
* Drug: Quetiapine
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)<br>Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day ((1100 and 2300 hours). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. | Drug: Marijuana<br>* 0,6.2% THC<br>* Other names: cannabis;Drug: Quetiapine<br>* 200 mg/day<br>* Other names: seroquel;|
| Placebo Comparator: Placebo, Marijuana (6.2%, 0.0%)<br>Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. | Drug: Marijuana<br>* 0,6.2% THC<br>* Other names: cannabis;Drug: Placebo oral capsule<br> <br> * Other names: Riboflavin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Days 1-3 (Baseline) and Days 6-8 (Relapse Phase) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quetiapine, smoked marijuana, marijuana use