Trial record 16 of 127 for:    marijuana | Open Studies | United States

Quetiapine Pharmacotherapy for Cannabis Dependence (QUEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01697709
First received: September 28, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

Despite a benign public perception, marijuana use disorders represent a significant public health problem. The development of safe and effective pharmacotherapies for marijuana dependence is an important unmet public health need. Quetiapine, an effective atypical antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1, and adrenergic receptors, is a promising treatment for substance use disorders. In animal models, quetiapine blocks the enhancement of reward by cocaine, which is likely due to its actions on both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine have shown benefit for the treatment of alcohol and cocaine use disorders.

Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis, mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the treatment of marijuana dependence conducted by our research group determined that quetiapine was well-tolerated and associated with reductions in marijuana use indicating that it is a promising agent deserving of further study in marijuana-dependent outpatients.

The proposed research project is a randomized double-blind placebo-controlled clinical trial to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a 12-week period. All participants will receive Medical Management, a medication adherence focused psychosocial intervention that facilitates compliance with study medication and other study procedures, promotes abstinence from marijuana and other substances, and encourages mutual-support group attendance. All participants will receive voucher incentives for compliance with study visit attendance, returning study medication bottles, and completing other study procedures, with the objective of achieving a highly compliant sample. The goal of this phase II clinical trial is to build on our promising open-label pilot study results and examine the efficacy of quetiapine on participants' marijuana consumption under placebo-controlled double-blind conditions using an abstinence-initiation model, where participants will be using marijuana regularly at study entry, reduce their use, and then achieve abstinence. The specific aims of the projects are to determine whether quetiapine is superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.


Condition Intervention Phase
Cannabis Dependence
Drug: Quetiapine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quetiapine Pharmacotherapy for Cannabis Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Marijuana Use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The daily dollar value of marijuana used averaged over a one-week period as recorded by the Timeline Followback method and confirmed by creatinine-normalized quantitative urine THC levels.


Secondary Outcome Measures:
  • Marijuana Abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The number of abstinent days per week as recorded by the Timeline Followback method and confirmed by creatinine-normalized quantitative urine THC levels

  • Urine toxicology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Twice weekly urine toxicology samples negative for cannabinoids - dichotomous longitudinal

  • Marijuana withdrawal symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured by weekly Marijuana Withdrawal Checklist (MWC) - continuous longitudinal

  • Marijuana craving [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured by weekly Marijuana Craving Questionnaire (MCQ) - continuous longitudinal

  • Sleep disturbance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured by the Medical Outcomes Study—Sleep Scale (MOS-SS) - continuous longitudinal


Other Outcome Measures:
  • Retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Study drop out will be recorded.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo medication
Drug: Placebo
Experimental: quetiapine
Quetiapine treatment
Drug: Quetiapine
Quetiapine pharmacotherapy for cannabis dependence
Other Name: Seroquel

Detailed Description:

In a 12-week randomized double-blind placebo-controlled clinical trial, we will evaluate the efficacy of quetiapine for the treatment of marijuana dependence in 150 outpatients. Participants will be randomly assigned to treatment under double-blind conditions with either a fixed dosing schedule of quetiapine or placebo. All participants will receive Medical Management, a medication adherence focused psychosocial intervention that facilitates compliance with study medication and other study procedures, and promotes abstinence from marijuana and other substances. All participants will receive progressive voucher incentives for compliance with study visit attendance and completing other study procedures, with the objective of achieving a highly compliant sample.

The results of a dose-finding pilot study of quetiapine for the treatment of marijuana dependence (see Preliminary Studies) suggests that the ideal dosing for the proposed project is a single 300 mg dose every evening, achieved after a gradual three-week titration. Clinical experience with this medication for treatment of marijuana dependence indicates that a gradual upward titration of dose is advisable to maximize tolerability and that morning dosing was poorly tolerated. Quetiapine (immediate release formulation) will be administered in 25 and 100 mg capsules; placebo capsules will appear identical to the quetiapine capsules. Participants in both treatment arms will take the same number of pills on the same schedule. Study medication will be dispensed on a weekly basis starting with the baseline visit. Quetiapine will be titrated over a three-week period to the target dose of 300 mg or the maximum tolerated dose. The research psychiatrist will make dose reductions for tolerability if necessary.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Meets DSM-IV-TR criteria for
  2. Reports using marijuana an average of 5 days per week over the past 28 days
  3. Between the ages of 18 and 60
  4. Able to provide informed consent and comply with study procedures
  5. Seeking treatment for cannabis dependence

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 investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study.
  3. Patients currently taking prescribed psychotropic medications.
  4. History of allergic reaction, 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 hypertension (>140/90 mm Hg), which might make participation hazardous.
  7. 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)
  8. Current DSM-IV diagnosis of an alcohol or substance use disorder (abuse or dependence) other than marijuana or nicotine dependence.
  9. Positive confirmed result on urine toxicology screen.
  10. Are legally mandated to participate in a substance use disorder treatment program.
  11. Increased risk for suicide.
  12. QTc prolongation (screening electrocardiogram with Qtc > 450 msec for men, QTc > 470 msec for women) or history of QTc prolongation or using concomitant medications which prolong QTc interval.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697709

Contacts
Contact: John J Mariani, MD 2129233031 jm2330@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: John J Mariani, MD    212-923-3031    jm2330@columbia.edu   
Principal Investigator: John J Mariani, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: John J Mariani, MD Columbia University/NYSPI
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01697709     History of Changes
Other Study ID Numbers: 6623, 1R01DA031826
Study First Received: September 28, 2012
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
cannabis
marijuana
pharmacotherapy

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014