Study of Quetiapine Treatment for Cannabis Dependence

NCT00954681 | Completed Phase 2 Results DMC

• 2 other identifiers: 5911K23DA021209
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Marijuana is the most commonly used illicit drug in the United States. However, the treatment options for cannabis dependence are limited; notably, no effective pharmacotherapy has been developed. Conceptually, the ideal medication treatment for cannabis dependence would:

1. 1.be safe when administered to patients actively using cannabis
2. 2.reduce cannabis intake and promote abstinence
3. 3.treat the symptoms of cannabis withdrawal
4. 4.reduce craving and relapse risk
5. 5.have a low abuse liability.

Conditions

Cannabis Dependence

Keywords

Cannabis; quetiapine

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Quetiapine

  Mean maximum tolerated dose of quetiapine

  assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

Study Arms (1)

quetiapine treatment

EXPERIMENTAL

Open label treatment with quetiapine

Drug: quetiapine

Interventions

quetiapine DRUG

Quetiapine treatment from 25 mg daily to 300 mg twice daily

Also known as: Seroquel

quetiapine treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65
• Meets DSM-IV criteria for current cannabis dependence
• Seeking treatment for cannabis dependence
• Reports using cannabis an average of five days per week over the past 28 days
• Capable of giving informed consent and complying with study procedures

You may not qualify if:

• Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
• Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study
• Receiving prescribed psychotropic medication
• Known history of allergy, intolerance, or hypersensitivity to quetiapine
• Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men
• Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous
• Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence
• Are legally mandated to participate in a substance use disorder treatment program
• Increased risk for suicide
• Diabetes (whether controlled or not), hyperglycemia (fasting glucose \> 100 mg/dl), obesity (BMI \> 30) and elevated lipids (cholesterol \> 200 mg/dl; triglycerides \> 150 mg/dl).

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Substance Treatment Research Service (STARS) of Columbia University

New York, New York, 10032, United States

Location

Related Links

• Substance Treatment Research Service (STARS) of Columbia University

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: John J. Mariani
• Organization: NYSPI/Columbia University

john.mariani@nyspi.columbia.edu

6467746140

Study Officials

• John J Mariani, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 24, 2019
• Results First Posted: September 6, 2017

Record last verified: 2019-04

Locations

US (1)