Effect of Quetiapine on Marijuana Withdrawal and Relapse

This study has been completed.
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00743366
First received: August 26, 2008
Last updated: February 4, 2013
Last verified: February 2013

August 26, 2008
February 4, 2013
August 2008
March 2009   (final data collection date for primary outcome measure)
Marijuana relapse [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Marijuana relapse [ Designated as safety issue: No ]
  • Marijuana's direct effects [ Designated as safety issue: No ]
  • Marijuana withdrawal symptoms [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00743366 on ClinicalTrials.gov Archive Site
Marijuana Withdrawal [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Not Provided
marijuana's direct effects [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Not Provided
 
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Effect of Quetiapine on Marijuana Withdrawal and Relapse

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Marijuana Smoking
  • Drug: Marijuana
    0,6.9% THC
    Other Name: cannabis
  • Drug: Quetiapine
    0, 200 mg/day
    Other Name: seroquel
Experimental: quetiapine, marijuana
quetiapine's effects on marijuana withdrawal and relapse
Interventions:
  • Drug: Marijuana
  • Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00743366
5685, 5P50DA009236
No
New York State Psychiatric Institute
New York State Psychiatric Institute
  • Research Foundation for Mental Hygiene, Inc.
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
New York State Psychiatric Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP