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Effect of Quetiapine on Marijuana Withdrawal and Relapse

Primary Purpose

Marijuana Smoking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Marijuana
Quetiapine
Placebo oral capsule
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Marijuana Smoking focused on measuring quetiapine, smoked marijuana, marijuana use

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)

Placebo, Marijuana (6.2%, 0.0%)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measure of Relapse: Change in Puffs Chosen Between Baseline and 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.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2008
Last Updated
July 17, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00743366
Brief Title
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Official Title
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Smoking
Keywords
quetiapine, smoked marijuana, marijuana use

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, Marijuana (6.2%, 0.0%)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Marijuana
Other Intervention Name(s)
cannabis
Intervention Description
0,6.2% THC
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
seroquel
Intervention Description
200 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Riboflavin
Primary Outcome Measure Information:
Title
Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
Description
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.
Time Frame
Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, Ph.D
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22741619
Citation
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.
Results Reference
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Effect of Quetiapine on Marijuana Withdrawal and Relapse

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