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Effect of Quetiapine on Marijuana Withdrawal and Relapse

This study has been completed.
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00743366
First received: August 26, 2008
Last updated: July 17, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Marijuana Smoking Drug: Marijuana Drug: Quetiapine Drug: Placebo oral capsule Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Quetiapine on Marijuana Withdrawal and Relapse

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase [ Time Frame: 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.



Enrollment: 20
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)

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
0,6.2% THC
Other Name: cannabis
Drug: Quetiapine
200 mg/day
Other Name: seroquel
Placebo Comparator: Placebo, Marijuana (6.2%, 0.0%)
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
0,6.2% THC
Other Name: cannabis
Drug: Placebo oral capsule
Other Name: Riboflavin

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.
  Eligibility

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743366

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743366     History of Changes
Other Study ID Numbers: 5685
5P50DA009236 ( U.S. NIH Grant/Contract )
Study First Received: August 26, 2008
Results First Received: October 20, 2016
Last Updated: July 17, 2017

Keywords provided by New York State Psychiatric Institute:
quetiapine
smoked marijuana
marijuana use

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Quetiapine Fumarate
Riboflavin
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 19, 2017