Effect of Quetiapine on Marijuana Withdrawal and Relapse

Phase 2

Completed

• Conditions: Marijuana Smoking
• Interventions: Drug: Marijuana; Drug: Placebo oral capsule; Drug: Quetiapine

• Registration Number: NCT00743366
• Lead Sponsor: New York State Psychiatric Institute

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-28
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2016-10-20
• Results First Submitted QC: 2017-06-12
• Status Verified: 2017-07
• Results First Posted: 2017-07-12
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo, Marijuana (6.2%, 0.0%)	Marijuana	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.
Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)	Marijuana	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.
Placebo, Marijuana (6.2%, 0.0%)	Placebo oral capsule	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.
Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)	Quetiapine	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States