Commonwealth Research Center

Clozapine, Cannabis and First Episode Schizophrenia

Funding: National Institute of Mental Health (NIMH)

Principle Investigator: Alan I. Green, MD

Co-Principle Investigators: Robert E. Drake, M.D., Ph.D. and Suzanna V. Zimmet, M.D.

Co-Investigators and Study Staff: Theo Manschreck, M.D., Larry Seidman, Ph.D., Carl Salzman, M.D., Brina Caplan, Ph.D., Ree Dawson, Ph.D., Martha Schinagle, M.D., Joanne Wojcik, R.N., M.S., Raquelle Mesholam, Ph.D., Wilson Woo, Ph.D., Haley Milner, B.S., Leontyne Goodwin, M.A., Meg Harrison, M.A.

This research project investigates the comparative effects of clozapine and risperidone in patients within their first episode of schizophrenia who are comorbid for Cannabis Use Disorder, which is a common comorbid condition in first episode patients with schizophrenia. Comorbid Cannabis Use Disorder in patients with schizophrenia is associated with a poor outcome, particularly if cannabis use is continued after the initiation of antipsychotic medication. Preliminary data shows that clozapine decreases cannabis use in patients with schizophrenia and is clinically efficacious in first episode patients for psychosis.

The overarching hypothesis of this 52-week intent-to-treat study is that clozapine, compared to risperidone, will limit cannabis use and will also improve the outcome of first episode patients with schizophrenia who are comborbid for Cannabis Use Disorder. In addition, we will be able to test the hypothesis that patients treated with clozapine will have better short-term and long-term outcomes than patients treated with risperidone as assessed by cannabis and other drug use (including abstinence, days of use, intensity of use, and global severity of use), global functioning, clinical symptoms, quality of life, and neurocognitive function.

Patients enrolled in this study will receive free study medication, regular contact with health care professionals and other members of the research team, a brief physical exam, an electrocardiogram, and weekly monitoring of blood pressure, pulse, temperature, and weight. Weekly blood tests will be completed during the study to assess white blood count, as well as weekly blood tests of Troponin I for the first six weeks of the study and blood tests of blood glucose levels once a month for the first four months and then every three months. Patients will also have the opportunity to participate in group therapy, which focuses on understanding the illness and its treatment, stress reduction, maintenance of self-esteem, and peer support. The clinical implication of this study is that clozapine may have a clear therapeutic advantage for patients in their first episode of schizophrenia who are comorbid for Cannabis Use Disorder and may well be considered the drug of choice for them.

If you would like further information on this study, please contact Meg Harrison, M.A., Director of Recruitment, at (617) 626-9634, pager # (617) 339-2496, or email at [email protected].