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
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:
  • Marijuana relapse [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Marijuana Withdrawal [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • marijuana's direct effects [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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, marijuana
quetiapine's effects on marijuana withdrawal and relapse
Drug: Marijuana
0,6.9% THC
Other Name: cannabis
Drug: Quetiapine
0, 200 mg/day
Other Name: seroquel

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
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.
Investigators
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743366     History of Changes
Other Study ID Numbers: 5685, 5P50DA009236
Study First Received: August 26, 2008
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Marijuana Abuse
Marijuana Smoking
Smoking
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Food Habits
Habits
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014