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Clozapine for Cannabis Use in Schizophrenia

NCT01639872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-05-05

Study results available
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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.

Conditions

  • Schizophrenia
  • Cannabis Abuse
  • Cannabis Dependence
  • Dual Diagnosis

Interventions

DRUG

Clozapine

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

DRUG

Risperidone

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

Sponsors & Collaborators

  • University of South Carolina

    collaborator OTHER

  • Michigan State University

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Alan I Green, MD · Dartmouth College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-01
Primary Completion
2017-03-29
Completion
2017-03-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639872 on ClinicalTrials.gov