Clozapine for Cannabis Use in Schizophrenia



Status:Completed
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:May 1, 2013
End Date:March 29, 2017

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Clozapine for Cannabis Use Disorder in Schizophrenia

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.

Cannabis use disorder (CUD), which is up to ten times more common in patients with
schizophrenia (SCZ) than in the general population, worsens the course of this severe
psychiatric disorder. Since SCZ occurs in 1% of the population, the co-occurrence of CUD in
13% to 42% of people with this disorder presents society with an important public health
problem. Unfortunately, most antipsychotics available for treatment of patients with SCZ do
not appear to limit their cannabis use. Moreover, the one antipsychotic that preliminary data
suggest may well limit cannabis use in these patients, clozapine (CLOZ), is not used for this
purpose; it is reserved for patients whose psychosis is treatment resistant.

The overarching idea behind this proposal, however, is that CLOZ's use is being unreasonably
restricted and should be made more widely available for patients with SCZ who have a
co-occurring CUD but whose psychosis is not necessarily treatment resistant. This notion is
supported by our preliminary clinical and animal data on the effects of CLOZ, as well as our
neurobiological model of the basis of cannabis use in patients with SCZ that provides a
pharmacologic rationale for this effect of CLOZ.

Even given all the arguments favoring the potential benefits of CLOZ in patients with SCZ and
CUD, however, its side effect profile will likely limit its use until a fully powered study
demonstrates its ability to decrease cannabis use in patients with SCZ. This proposal aims to
launch such a study. If, as we hypothesize, this study confirms and extends our previous
preliminary data of the effects of CLOZ in patients with SCZ and CUD, it will provide a
strong impetus to expand the use of CLOZ in this population.

In the proposed study, 132 patients who are comorbid for both SCZ and CUD will be randomized
to a 12-week treatment course with either CLOZ or risperidone (RISP) to test the hypothesis
that patients treated with CLOZ will have decreased cannabis use as compared to patients
treated with RISP. In addition, the study will determine whether patients treated with CLOZ
will have improvements in psychiatric symptoms, quality of life neuropsychological functions
as compared to those taking RISP. We will also explore whether patients taking CLOZ show
improved reward responsiveness as compared to those taking RISP. Finally, this study will
explore whether those patients with the val/val genotype at the COMT Val158Met locus are more
likely to decrease cannabis use during CLOZ treatment than are those without the val/val COMT
genotype.

Should this study indicate that CLOZ will lessen cannabis use in patients with SCZ more than
RISP, it will provide evidence needed to begin to shift clinical practice toward its use in
these patients.

Inclusion Criteria:

- Clinical diagnosis of schizophrenia

- Clinical diagnosis of a cannabis use disorder (abuse or dependence)

Exclusion Criteria:

- Pregnant,trying to become pregnant or nursing

- History of a seizure disorder

- Current treatment with clozapine or risperidone

- Contraindication to treatment with clozapine or risperidone
We found this trial at
9
sites
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Philip Harvey, Ph.D.
Phone: 305-355-8186
University of Miami A private research university with more than 15,000 students from around the...
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Columbia, South Carolina 29208
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12772 Valley View Street
Garden Grove, California 92845
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Grand Rapids, Michigan 49503
Principal Investigator: Eric Achtyes, MD
Phone: 616-965-8200
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Alan I Green, MD
Phone: 603-271-7642
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Oakland, California 94612
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Raleigh, North Carolina 27610
Principal Investigator: Fred Jarskog, MD
Phone: 919-966-3915
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Raleigh, NC
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Rutland, Vermont 05701
Principal Investigator: Gordon Frankle, MD
Phone: 603-653-1802
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Worcester, Massachusetts 01605
Principal Investigator: Xiaoduo Fan, M.D.
Phone: 508-856-8323
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Worcester, MA
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