Effect of Quetiapine on Marijuana Withdrawal and Relapse

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Marijuana Smoking

Treatments: Drug: Placebo oral capsule; Drug: Marijuana; Drug: Quetiapine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00743366

5685

5P50DA009236 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)

Experimental group

Description:

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.

Treatment:

Drug: Quetiapine

Drug: Marijuana

Placebo, Marijuana (6.2%, 0.0%)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Marijuana

Drug: Placebo oral capsule