Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual

This study has been completed.
Sponsor:
Collaborators:
University of Missouri, Kansas City
VA Medical Center-West Los Angeles
University of South Carolina
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00498550
First received: July 6, 2007
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Dual Diagnosis
Schizoaffective Disorder
Psychotic Disorder
Cannabis Abuse
Drug: Clozapine
Drug: Treatment as usual
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabis and Schizophrenia: Effects of Clozapine

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Days of Cannabis Use as Measured by the Timeline Followback [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study utilized the 24 item BPRS. Each item is rated a 0 (not present) to 6 (severe) scale. The minimum score for this assessment is 0 and the maximum score is 144.


Enrollment: 31
Study Start Date: October 2000
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clozapine
Clozapine, Clozaril
Drug: Clozapine
Clozapine up to 550mg per day
Other Name: Clozaril
Active Comparator: Treatment as usual
Treatment as usual with any antipsychotic other than Clozapine.
Drug: Treatment as usual
Remain on pre-study antipsychotic treatment

Detailed Description:

Individuals with schizophrenia have a high risk of becoming addicted to drugs; between 13 to 42% of schizophrenics are addicted to marijuana. These individuals often have difficulties adhering to a substance abuse treatment program, and have an increased chance of marijuana relapse. Marijuana use by schizophrenics has also been associated with clinical exacerbations, noncompliance with antipsychotic medications, poor global functioning, and increased rehospitalization rates. While antipsychotic medications are often effective in controlling symptoms of schizophrenia, they are not always effective in preventing substance abuse. Clozapine, an atypical antipsychotic drug, is currently used to treat schizophrenia. Preliminary research has shown that clozapine is more successful at reducing drug relapse rates in individuals with schizophrenia, as compared to other antipsychotic medications, including olanzapine and risperidone. The purpose of this study is to compare the effectiveness of clozapine as compared to other oral antipsychotic treatment, including combinations of up to two antipsychotics, in reducing marijuana use in schizophrenic individuals.

This study will enroll individuals with schizophrenia who are currently taking any oral antipsychotic other than clozapine, including those taking up to two oral antipsychotic, and who are also addicted to marijuana. The study will begin with a 1-week assessment phase, during which all participants will continue taking olanzapine or risperidone. Participants will undergo a physical examination and have blood drawn for laboratory tests. Information pertaining to their medical, psychiatric, and substance use history will also be collected. Urine tests and breathalyzers will be used to screen for the presence of alcohol and drugs. Following the assessment phase, participants will be randomly assigned to switch to clozapine or remain on their prestudy antipsychotic for 12 weeks. Participants remaining on their prestudy antipsychotic treatment will continue to receive the same dose for the entire study. Participants taking clozapine will initially receive a daily dose of 12.5 mg, which will be increased to a maximum of 400 mg per day, as tolerated. Study visits will take place once a week. At each visit, medication side effects, physical and psychological symptoms, substance use, treatment services received, and living situation will be assessed. Blood will be drawn for laboratory tests. Drug and alcohol levels will be monitored three times a week through urine and breathalyzer tests. Quality of life questionnaires will be administered once a month.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498550

Locations
United States, California
West LA VAHCS
Los Angeles, California, United States, 90073
United States, Missouri
University Missouri
Kansas City, Missouri, United States, 64108
United States, New Hampshire
Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States, 03101
United States, South Carolina
University South Carolina
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
University of Missouri, Kansas City
VA Medical Center-West Los Angeles
University of South Carolina
Investigators
Principal Investigator: Alan Green, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00498550     History of Changes
Obsolete Identifiers: NCT00149955
Other Study ID Numbers: NCT00149955, R01DA013196, R01 DA013196, DPMCDA
Study First Received: July 6, 2007
Results First Received: September 28, 2011
Last Updated: December 15, 2011
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
Clozapine
Schizophrenia
Dual Diagnosis
Substance Abuse
Cannabis Abuse

Additional relevant MeSH terms:
Disease
Marijuana Abuse
Mental Disorders
Psychotic Disorders
Schizophrenia
Chemically-Induced Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Substance-Related Disorders
Clozapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014