Phase 2
N=15
Study of Quetiapine Treatment for Cannabis Dependence
Cannabis Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00954681 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Maximum Tolerated Dose of Quetiapine — 197 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- quetiapine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Quetiapine |
197 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT00954681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.