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Effect of Quetiapine on Marijuana Withdrawal and Relapse
This study is currently recruiting participants.
Verified by New York State Psychiatric Institute, August 2008
Sponsors and Collaborators: New York State Psychiatric Institute
Research Foundation for Mental Hygiene
National Institute on Drug Abuse (NIDA)
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743366
  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. It is hypothesized that quetiapine will decrease marijuana withdrawal and relapse. Primary outcome measures will be

  1. marijuana's direct effects
  2. marijuana withdrawal syndromes
  3. marijuana relapse. It is also hypothesized that marijuana withdrawal will be associated with increased levels of stress hormones. A secondary measure will be salivary cortisol.

Condition Intervention Phase
Marijuana Smoking
Drug: Marijuana
Drug: Quetiapine
Phase II

MedlinePlus related topics: Marijuana Smoking
Drug Information available for: Quetiapine Quetiapine fumarate Cannabis GW-1000
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Efficacy Study
Official Title: Effect of Quetiapine on Marijuana Withdrawal and Relapse

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

Primary Outcome Measures:
  • Marijuana's direct effects [ Designated as safety issue: No ]
  • Marijuana withdrawal symptoms [ Designated as safety issue: No ]
  • Marijuana relapse [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Intervention Details:
    Drug: Marijuana
    0,6.9% THC
    Drug: Quetiapine
    0, 200 mg/day
Detailed Description:

Quetiapine improves sleep and reduces anxiety and irritability, which are symptoms of marijuana withdrawal. Further, there are case reports showing that marijuana-dependent schizophrenics maintained on quetiapine had a 97.3% reduction in marijuana use. Thus, the purpose of this study is to determine if quetiapine decreases marijuana's direct effects, symptoms of marijuana withdrawal and marijuana relapse in the laboratory. The study will utilize and 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 or active marijuana 6 times per 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743366

Contacts
Contact: Margaret Haney, Ph.D 212-543-5175

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene
Investigators
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
  More Information

Study ID Numbers: 5685
Study First Received: August 26, 2008
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00743366  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Smoking
Quetiapine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Marijuana Smoking
Marijuana Abuse

Additional relevant MeSH terms:
Habits
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009