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Effect of Quetiapine on Marijuana Withdrawal and Relapse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743366
First Posted: August 28, 2008
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
August 26, 2008
August 28, 2008
October 20, 2016
July 12, 2017
August 18, 2017
August 2008
March 2009   (Final data collection date for primary outcome measure)
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.

  • Marijuana's direct effects
  • Marijuana withdrawal symptoms
  • Marijuana relapse
Complete list of historical versions of study NCT00743366 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Marijuana Smoking
  • Drug: Marijuana
    0,6.2% THC
    Other Name: cannabis
  • Drug: Quetiapine
    200 mg/day
    Other Name: seroquel
  • Drug: Placebo oral capsule
    Other Name: Riboflavin
  • 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.

    Interventions:
    • Drug: Marijuana
    • Drug: Quetiapine
  • 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.
    Interventions:
    • Drug: Marijuana
    • Drug: Placebo oral capsule
Cooper ZD, Foltin RW, Hart CL, Vosburg SK, Comer SD, Haney M. A human laboratory study investigating the effects of quetiapine on marijuana withdrawal and relapse in daily marijuana smokers. Addict Biol. 2013 Nov;18(6):993-1002. doi: 10.1111/j.1369-1600.2012.00461.x. Epub 2012 Jun 28.

*   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
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00743366
5685
5P50DA009236 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
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
July 2017

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