Phase 4
N=31
Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
Schizophrenia · Dual Diagnosis · Schizoaffective Disorder · Psychotic Disorder · Cannabis Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00498550 ↗Enrolled (actual)
31
Serious AEs
25.8%
Results posted
Jan 2012
Primary outcome: Primary: Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) — 0.02; 4.56 Joints per week — p=.088
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clozapine (Drug); Treatment as usual (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) |
0.02; 4.56 | .088 |
Summary
Many individuals with schizophrenia also suffer from marijuana addiction. Clozapine, an atypical antipsychotic medication, may prove useful at preventing drug relapse in schizophrenic individuals who are seeking treatment for marijuana addiction. The purpose of this study is to compare the effectiveness of clozapine, vs. treatment-as-usual with other oral antipsychotics at reducing marijuana use in schizophrenic individuals.
Eligibility Criteria
Inclusion Criteria
- Meets Diagnostic and Statical Manual of Mental Disorders IV (DSM-IV) diagnostic criteria for schizophrenia or schizoaffective disorder
- Meets diagnostic criteria for marijuana use disorder, as determined by a rating of 3 or higher on the Drug Use Scale (Abuse or Dependence)
- Used marijuana on 5 or more days during the 3 weeks prior to study entry
- Taking any oral antipsychotic other than clozapine in the month prior to study entry. (Patients may take a second oral antipsychotic medication, if approved by the Medication Adjustment Group)
- If female, willing to use effective contraception throughout the study
Exclusion Criteria
- Unable to take clozapine for medical reasons, including previous clozapine-induced granulocytopenia, myeloproliferative disorder, white blood cell count less than 3500/mm3, or history of seizures
- Currently taking clozapine
- Currently taking other psychotropic medications for the treatment of substance use (e.g., disulfiram, naltrexone, acamprosate, inderol, tegretol, topiramate, and pramipexole)
- Participated in a clinical trial of an investigational drug within 30 days of study entry
- Currently participating in a psychosocial intervention clinical trial
- Has medical or legal problems that may entail a jail or hospital stay during the study
- Has a developmental disability that would make study participation difficult
- Currently enrolled in a live-in treatment program for substance use disorders
- Pregnant or plans to become pregnant during the study
Data sourced from ClinicalTrials.gov (NCT00498550). 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.