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)
15
Enrollment
1
Location
1
Arm
12
Duration (Months)
1.3
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Substance Treatment Research Service (STARS) of Columbia UniversityNew YorkNew YorkUnited States10032

    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:

    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleQuetiapine Treatment
    Arm/Group DescriptionOpen label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
    Period Title: Overall Study
    STARTED15
    COMPLETED10
    NOT COMPLETED5

    Baseline Characteristics

    Arm/Group TitleQuetiapine Treatment
    Arm/Group DescriptionOpen label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
    Overall Participants15
    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
    TitleMaximum Tolerated Dose of Quetiapine
    DescriptionMean maximum tolerated dose of quetiapine
    Time Frameassesssed 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 TitleOpen-Label Quetiapine Treatment
    Arm/Group DescriptionParticipants receiving quetiapine under open-label conditions.
    Measure Participants15
    Mean (Full Range) [milligrams]
    197

    Adverse Events

    Time Frame8 weeks
    Adverse Event Reporting Description
    Arm/Group TitleQuetiapine Treatment
    Arm/Group DescriptionOpen 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
    Total0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Quetiapine Treatment
    Affected / at Risk (%)# Events
    Total12/15 (80%)
    Nervous system disorders
    fatigue12/15 (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.

    Results Point of Contact

    Name/TitleJohn J. Mariani
    OrganizationNYSPI/Columbia University
    Phone6467746140 ext 646
    Emailjohn.mariani@nyspi.columbia.edu
    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