STUC: Study of Quetiapine Treatment for Cannabis Dependence

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00954681
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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. be safe when administered to patients actively using cannabis

2. reduce cannabis intake and promote abstinence

3. treat the symptoms of cannabis withdrawal

4. reduce craving and relapse risk

5. have a low abuse liability.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Dependence	Drug: quetiapine	Phase 2

Detailed Description

Conceptually, the pharmacodynamic and clinical actions of quetiapine suggest that it may be useful for cannabis dependence. By antagonizing dopamine, quetiapine may interfere with the reinforcing effects of cannabis, while serotonin type 2A, histamine type 1, and adrenergic receptor antagonism may reduce cannabis withdrawal symptoms, primarily by sedating and anxiolytic effects. The proposed research project is an open-label pilot study to evaluate the tolerability and ideal target dosing range for quetiapine treatment of cannabis dependence over an eight-week period. The purpose of this pilot study is to obtain preliminary data regarding the potential efficacy, tolerability and safety of quetiapine treatment of cannabis dependence before conducting a larger double-blind trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: quetiapine treatment Open label treatment with quetiapine	Drug: quetiapine; Quetiapine treatment from 25 mg daily to 300 mg twice daily; Other Names: Seroquel

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose of Quetiapine [assesssed daily during 8 weeks of study, mean maximum tolerated dose reported]

   Mean maximum tolerated dose of quetiapine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Between the ages of 18-65

2. Meets DSM-IV criteria for current cannabis dependence

3. Seeking treatment for cannabis dependence

4. Reports using cannabis an average of five days per week over the past 28 days

5. Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

1. Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder

2. 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

3. Receiving prescribed psychotropic medication

4. Known history of allergy, intolerance, or hypersensitivity to quetiapine

5. Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men

6. Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous

7. Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence

8. Are legally mandated to participate in a substance use disorder treatment program

9. Increased risk for suicide

10. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Substance Treatment Research Service (STARS) of Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

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

Investigators

• Principal Investigator: John J Mariani, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Substance Treatment Research Service (STARS) of Columbia University

Publications

None provided.

• Responsible Party: John Mariani MD, research psychiatrist, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00954681
• Other Study ID Numbers: 5911; K23DA021209
• First Posted: Aug 7, 2009
• Last Update Posted: Apr 24, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by John Mariani MD, research psychiatrist, New York State Psychiatric Institute: Cannabis; quetiapine
• Additional relevant MeSH terms: Marijuana Abuse; Quetiapine Fumarate

Study Results

Participant Flow

Arm/Group Title	Quetiapine Treatment
Arm/Group Description	Open label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Period Title: Overall Study
STARTED	15
COMPLETED	10
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Quetiapine Treatment
Arm/Group Description	Open label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Overall Participants	15
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	28.2
Sex: Female, Male (Count of Participants)
Female	4 26.7%
Male	11 73.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 20%
Not Hispanic or Latino	12 80%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 46.7%
White	3 20%
More than one race	0 0%
Unknown or Not Reported	5 33.3%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose of Quetiapine
Description	Mean maximum tolerated dose of quetiapine
Time Frame	assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

Outcome Measure Data

Analysis Population Description

Mean maximum dose of quetipaine achieved

Arm/Group Title	Open-Label Quetiapine Treatment
Arm/Group Description	Participants receiving quetiapine under open-label conditions.
Measure Participants	15
Mean (Full Range) [milligrams]	197

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Quetiapine Treatment
Arm/Group Description	Open label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
All Cause Mortality
	Quetiapine Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Quetiapine Treatment
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Quetiapine Treatment
	Affected / at Risk (%)	# Events
Total	12/15 (80%)
Nervous system disorders
fatigue	12/15 (80%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.