CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
Clozapine +1 moredrug
Likely dose
Clozapine 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01639872
NCT01639872Phase 4Completed

Clozapine for Cannabis Use Disorder in Schizophrenia

Dartmouth-Hitchcock Medical Center·interventional·Posted Jul 13, 2012·Updated May 5, 2020

In Brief

A Phase 4 clinical trial evaluating Clozapine and Risperidone for Schizophrenia and 3 related conditions. Completed, enrolled 49 participants across 9 sites.

Detailed Summary

Many individuals with schizophrenia also suffer from marijuana addiction that worsens their problems related to schizophrenia. Most of the medications prescribed for schizophrenia have no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not commonly used due to its side effects and is reserved for people who do not respond to other antipsychotic medications. In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a cannabis use disorder will be randomized to a 12-week treatment course with either clozapine or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis that patient treated with clozapine will have decreased cannabis use as compared to patients treated with risperidone. Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with schizophrenia more than risperidone, it will provide evidence needed to begin to shift clinical practice toward its use in this population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2012
Enrollment StartMay 1, 2013
Primary CompletionMar 29, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.0 years ago

Interventions

Clozapinedrug

Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day

Risperidonedrug

Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day