search
Back to results

Study of Quetiapine Treatment for Cannabis Dependence (STUC)

Primary Purpose

Cannabis Dependence

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

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Cannabis, quetiapine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Substance Treatment Research Service (STARS) of Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

quetiapine treatment

Arm Description

Open label treatment with quetiapine

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose of Quetiapine
Mean maximum tolerated dose of quetiapine

Secondary Outcome Measures

Full Information

First Posted
August 5, 2009
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00954681
Brief Title
Study of Quetiapine Treatment for Cannabis Dependence
Acronym
STUC
Official Title
Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
Cannabis, quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quetiapine treatment
Arm Type
Experimental
Arm Description
Open label treatment with quetiapine
Intervention Type
Drug
Intervention Name(s)
quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Quetiapine treatment from 25 mg daily to 300 mg twice daily
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Mariani, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Treatment Research Service (STARS) of Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stars.columbia.edu
Description
Substance Treatment Research Service (STARS) of Columbia University

Learn more about this trial

Study of Quetiapine Treatment for Cannabis Dependence

We'll reach out to this number within 24 hrs