SchizophreniaPhase 4NCT00169026
Alcoholism and Schizophrenia: Effects of Clozapine
A Phase 4 study testing Clozapine versus typical (conventional) and atypical antipsychotic medications in people with Schizophrenia and Dual Diagnosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Schizophrenia, Dual Diagnosis, Schizoaffective Disorder
- What is being tested?
- Clozapine versus typical (conventional) and atypical antipsychotic medications
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Jan 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- Current diagnosis of an alcohol use disorder with active use in the last 30 days.
- The participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent.
- Ages 19-65.
- Taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization
- If taking depot medication, at least 3 injection cycles since the last injection prior to study randomization.
Who cannot join
- Contraindication to clozapine
- Women who are currently pregnant or who desire to become pregnant during the course of the study.
- Current and past treatment with clozapine
- Current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium).
- Meets DSM-IV criteria for current dependence of substances other than alcohol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Commonwealth Research Center
Jamaica Plain, Massachusetts, 02130
About this study
The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.
- Conditions
- Schizophrenia, Dual Diagnosis, Schizoaffective Disorder, Psychotic Disorder, Substance Abuse, Alcohol Abuse
- Being tested
- Clozapine versus typical (conventional) and atypical antipsychotic medications
- Keywords
- Clozapine, Atypical Antipsychotic, Conventional antipsychotic, Schizophrenia, Dual Diagnosis, Substance Abuse, Alcohol Abuse
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clozapine versus typical (conventional) and atypical antipsychotic medicationsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.
Secondary outcomes (1)
Clinical Measures: Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms; and Clinical Global Impression; neurological side affects, cognitive assessment and quality of life measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 1999
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Harvard Medical School (HMS and HSDM), Commonwealth Research Center, Massachusetts, Novartis
- Responsible party
- Principal investigator, Alan Green, Dartmouth-Hitchcock Medical Center
- Investigators
- Alan I Green, MD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169026
- Sponsor's protocol ID
- AA11904
- Status last verified
- Mar 2018
- First submitted
- 10 Sep 2005
- Last updated
- 14 Mar 2018
- Results posted
- No
Publications
Green AI, Zimmet SV, Strous RD, Schildkraut JJ. Clozapine for comorbid substance use disorder and schizophrenia: do patients with schizophrenia have a reward-deficiency syndrome that can be ameliorated by clozapine? Harv Rev Psychiatry. 1999 Mar-Apr;6(6):287-96. doi: 10.3109/10673229909017206.
PubMed 10370435
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcoholism and Schizophrenia: Effects of Clozapine
- ClinicalTrials.gov ID
- NCT00169026
- Acronym / sponsor ID
- AA11904
- Conditions
- Schizophrenia, Dual Diagnosis, Schizoaffective Disorder, Psychotic Disorder, Substance Abuse, Alcohol Abuse
- Keywords
- Clozapine, Atypical Antipsychotic, Conventional antipsychotic, Schizophrenia, Dual Diagnosis, Substance Abuse, Alcohol Abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 64 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Harvard Medical School (HMS and HSDM), Commonwealth Research Center, Massachusetts, Novartis
- Study start
- May 1999
- Study completion
- Jan 2004
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- Current diagnosis of an alcohol use disorder with active use in the last 30 days.
- The participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent.
- Ages 19-65.
- Taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization
Key exclusion criteria (5 listed)
- Contraindication to clozapine
- Women who are currently pregnant or who desire to become pregnant during the course of the study.
- Current and past treatment with clozapine
- Current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium).
- Meets DSM-IV criteria for current dependence of substances other than alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clozapine versus typical (conventional) and atypical antipsychotic medications | Drug | – |
Primary outcome
Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.
1 secondary outcome
Clinical Measures: Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms; and Clinical Global Impression; neurological side affects, cognitive assessment and quality of life measure.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Background: PubMed 10370435Green AI, Zimmet SV, Strous RD, Schildkraut JJ. Clozapine for comorbid substance use disorder and schizophrenia: do patients with schizophrenia have a reward-deficiency syndrome that can be ameliorated by clozapine? Harv Rev Psychiatry. 1999 Mar-Apr;6(6):287-96. doi: 10.3109/10673229909017206.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan I Green, MD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clozapine versus typical (conventional) and atypical antipsychotic medications in people with Schizophrenia and Dual Diagnosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.