Effect of Quetiapine on Marijuana Withdrawal and Relapse

NCT00743366 | Completed Phase 2 Results

• 2 other identifiers: 56855P50DA009236
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Smoking

Keywords

quetiapine; smoked marijuana; marijuana use

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Marijuana; Drug: Quetiapine

Placebo, Marijuana (6.2%, 0.0%)

PLACEBO COMPARATOR

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.

Drug: Marijuana; Drug: Placebo oral capsule

Interventions

Marijuana DRUG

0,6.2% THC

Also known as: cannabis

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

Quetiapine DRUG

200 mg/day

Also known as: seroquel

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

Placebo oral capsule DRUG

Also known as: Riboflavin

Placebo, Marijuana (6.2%, 0.0%)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years of age
• Women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, IUD)
• Normal body weight

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Research Foundation for Mental Hygiene, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 22741619 RESULT

MeSH Terms

Conditions

Marijuana Smoking; Marijuana Use

Interventions

nabiximols; Quetiapine Fumarate; Riboflavin

Condition Hierarchy (Ancestors)

Behavior; Smoking, Non-Tobacco Products; Smoking; Substance-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Ziva Cooper
• Organization: New York State Psychiatric Institute

reslabsurc@gmail.com

646-774-6129

Study Officials

• Margaret Haney, Ph.D

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 18, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-07

Locations

US (1)