SchizophreniaPhase 4NCT00145847
Naltrexone Treatment of Alcohol Abuse in Schizophrenia
A Phase 4 study of Schizophrenia and Mental Disorders, run by State University of New York - Upstate Medical University at 4 sites in United States.
Trial summary
The primary purpose of this study is to determine whether naltrexone is effective in the treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective disorder. Hypotheses are as follows: hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Schizophrenia, Mental Disorders, Alcohol Abuse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2003to May 2008
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
- DSM-IV diagnosis of Alcohol Abuse or Alcohol Dependence;
- Level of Drinking: At least four days of drinking in the 30 days prior to consent;
- Currently prescribed antipsychotic medication;
- Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, St. Joseph's Hospital Health Center, VA Medical Center) or at another location in the community at the time of randomization.
Who cannot join
- Inability to give adequate informed consent;
- Currently taking disulfiram (Antabuse) or naltrexone (ReVia/Depade);
- Current DSM-IV diagnosis of Opioid Dependence or Opioid Abuse;
- Currently taking ibuprofen or other potentially hepatotoxic medications in amount and/or frequency judged by the Principal Investigator to pose clinically significant added risk of hepatic injury;
- Current use of prescribed or non-prescribed opioid analgesics, such as methadone, morphine, codeine, heroin, meperidine, and all other opioids.
- Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control;
Show all 13Show fewer
- Female patients who are pregnant or nursing;
- Significant unstable medical problems, including any significant unstable psychiatric disorders. The study physician conducting the medical history and physical exam will exclude such clinically unstable individuals;
- AST levels greater than 3x upper limit of normal;
- Subjects who do not attend required screening appointments. Subsequent exclusion from the study for reasons related to non-attendance will be based on the judgment of the principal investigator;
- In need of acute medical detoxification from alcohol in the judgment of the study physician based on results from the Clinical Institute Withdrawal Assessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other information obtained;
- Scheduled surgery within 3 months of intake;
- Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Joseph's Mental Health Services
Syracuse, New York, 13203
Hutchings Psychiatric Center
Syracuse, New York, 13210
SUNY Upstate Medical University
Syracuse, New York, 13210
Veterans Administration Healthcare Center
Syracuse, New York, 13210
About this study
The primary purpose of this study is to determine whether naltrexone is effective in the treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective disorder. Hypotheses are as follows:
hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use.
hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services.
hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use.
Read the detailed description
The long-term goal of the proposed project is to improve the treatment of alcohol abuse and dependence in patients with schizophrenia and schizoaffective disorder. Alcohol use disorders are common among patients with severe mental illness. It is estimated that there may be as many as 750,000 individuals in the United States with comorbid schizophrenia and alcohol disorders. Alcohol disorder comorbidity requires treatment because it is associated with adverse consequences such as increased rates of hospitalization. Yet, to date, there are no reports of controlled trials testing the efficacy of pharmacological treatments for alcohol abuse or dependence in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with schizophrenia. The specific aims of this study are: To test the efficacy of naltrexone in reducing alcohol use among individuals with schizophrenia and schizoaffective disorder who also have alcohol abuse or dependence. We will test hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use. Our primary outcome measure will be the number of drinking days over the course of the treatment trial. To test naltrexone's efficacy in reducing psychiatric symptom severity and medical utilization by reducing alcohol use. We will test hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services. To determine the relationship between a) changes in alcohol use, and b) psychiatric symptom severity and inpatient and emergency service utilization. We will test hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use. The proposed research will study a cohort of 150 subjects in a double-blind, randomized, placebo-controlled trial of naltrexone using three times per week directly observed administration of medication. The study will be 6 months in duration, consisting of a 12-week course of naltrexone or placebo plus 3 monthly follow-up interviews after discontinuation of medication. Voucher incentives contingent on attendance will be provided to all subjects to ensure attendance for medication administration. Weekly motivational enhancement counseling sessions will also be provided to all subjects. Study outcomes will consist of self-report and biological measures of alcohol use as well as measures of psychiatric symptom severity and medical service utilization.
- Being tested
- Naltrexone or Placebo
- Keywords
- alcohol, schizophrenia, naltrexone
- Medical subject headings
- Schizophrenia, Mental Disorders, Alcoholism, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone or PlaceboDrug
Naltrexone or Placebo 50 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Active comparator | Naltrexone 50 mg per day, directly administered as 100 mg on Mondays, 100 mg on Wednesdays and 150 mg on Fridays Receives: Drug: Naltrexone or Placebo |
| Lactose pill | Placebo comparator | Not described Receives: Drug: Naltrexone or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of Alcohol Use
Measured: 12 weeks
Secondary outcomes (1)
Psychiatric Symptom Severity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Steven Batki, M.D., State University of New York - Upstate Medical University
- Investigators
- Steven L Batki, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145847
- Sponsor's protocol ID
- SUNY UMU IRB # 4800
- Other IDs
- 1R01AA013655-01A1
- Status last verified
- Jan 2013
- First submitted
- 1 Sep 2005
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batki SL, Dimmock JA, Leontieva L, Bowman ML, Gallinger L, Carey KB, Maisto SA, Canfield KM, McMaster T, Schweizer ML; (abstract) (2005) Recruitment and characteristics of alcohol dependent patients with schizophrenia. Alcoholism Clinical and Experimental Research 29 (5:suppl):78A (abstract 428)
Batki SL, Dimmock J, Hameed A, Cornell M, Wade M, Albrecht J, Maisto S, Carey K; (2001) Alcohol use measures in naltrexone treatment of alcohol dependence in schizophrenia: Preliminary analysis. Alcoholism Clinical and Experimental Research, 25 (5:suppl.):93A (abstract 522)
Batki SL, Dimmock J, Cornell M, Wade M, Carey K, Maisto S. (2002) Directly observed naltrexone treatment of alcohol dependence in schizophrenia: Preliminary analysis. Alcoholism Clinical and Experimental Research 26 (5:suppl.):83A (abstract 470)
Batki SL, Dimmock JA, Wade M, Gately PW, Cornell M, Maisto SA, Carey KB, Ploutz-Snyder R. Monitored naltrexone without counseling for alcohol abuse/dependence in schizophrenia-spectrum disorders. Am J Addict. 2007 Jul-Aug;16(4):253-9. doi: 10.1080/10550490701389732.
PubMed 17661192Carey KB, Leontieva L, Dimmock J, Maisto SA, Batki SL. Adapting Motivational Interventions for Comorbid Schizophrenia and Alcohol Use Disorders. Clin Psychol (New York). 2007 Mar;14(1):39-57. doi: 10.1111/j.1468-2850.2007.00061.x.
PubMed 19081784Batki, S. L., Dimmock, J. A., Leontieva, L., Bowman, M. L., Gallinger, L., Schweizer, M. L., Carey, K. B., Maisto, S. A., Canfield, K. M., McMaster, T., Ploutz-Snyder, R. (abstract) (2006). Associations among psychiatric symptoms, alcohol severity, and motivation to change in patients with schizophrenia and alcohol use disorders. American Journal on Addictions 15(4):321-322.
Batki, S.L., Dimmock, J.A., Leontieva, L., Bowman, M. L., Gallinger, L., Gately, P. W., Carey, K. B., Maisto, S. A., Canfield, K. M., Ploutz-Snyder, R. (abstract) (2006). Co-occurring substance use among patients with alcohol dependence and schizophrenia. Alcoholism Clinical and Experimental Research 30 (6: suppl.):162A (abstract 621)
Carey, K.B., Leontieva, L., Dimmock, J., Bowman, M., Gallinger, L., Gately, P., Maisto, S.A., Ploutz-Snyder, R., Batki, S.L. (abstract) (2006). Psychometrics of a short version of the problems assessment for substance-using psychiatric patients (PASSUP-SV) Alcoholism Clinical and Experimental Research 30(6: suppl.):206A (abstract 799)
Leontieva, L., Dimmock, J.A., Gately, P., Gallinger, L., Cavallerano, M., DeRycke, S., McMasters, T., Ploutz-Snyder, R., Strutynski, K., Carey, K.B., Maisto, S.A., & Batki, S.L.(abstract). Voucher-based incentives for adherence to research visits in schizophrenia and alcohol dependence.30th Annual Research Society on Alcoholism Meeting, Chicago, IL, USA, July, 2007
Leontieva L, Dimmock JA, Gately PW, Gallinger L, Ploutz-Snyder R, Batki SL. Voucher-based incentives for naltrexone treatment attendance in schizophrenia and alcohol use disorders. Psychiatr Serv. 2008 Mar;59(3):310-4. doi: 10.1176/ps.2008.59.3.310.
PubMed 18308913
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone Treatment of Alcohol Abuse in Schizophrenia
- ClinicalTrials.gov ID
- NCT00145847
- Acronym / sponsor ID
- SUNY UMU IRB # 4800
- Keywords
- alcohol, schizophrenia, naltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 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 primary purpose of this study is to determine whether naltrexone is effective in the treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective disorder. Hypotheses are as follows:
hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use.
hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services.
hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use.
Detailed description
The long-term goal of the proposed project is to improve the treatment of alcohol abuse and dependence in patients with schizophrenia and schizoaffective disorder. Alcohol use disorders are common among patients with severe mental illness. It is estimated that there may be as many as 750,000 individuals in the United States with comorbid schizophrenia and alcohol disorders. Alcohol disorder comorbidity requires treatment because it is associated with adverse consequences such as increased rates of hospitalization. Yet, to date, there are no reports of controlled trials testing the efficacy of pharmacological treatments for alcohol abuse or dependence in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with schizophrenia. The specific aims of this study are: To test the efficacy of naltrexone in reducing alcohol use among individuals with schizophrenia and schizoaffective disorder who also have alcohol abuse or dependence. We will test hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use. Our primary outcome measure will be the number of drinking days over the course of the treatment trial. To test naltrexone's efficacy in reducing psychiatric symptom severity and medical utilization by reducing alcohol use. We will test hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services. To determine the relationship between a) changes in alcohol use, and b) psychiatric symptom severity and inpatient and emergency service utilization. We will test hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use. The proposed research will study a cohort of 150 subjects in a double-blind, randomized, placebo-controlled trial of naltrexone using three times per week directly observed administration of medication. The study will be 6 months in duration, consisting of a 12-week course of naltrexone or placebo plus 3 monthly follow-up interviews after discontinuation of medication. Voucher incentives contingent on attendance will be provided to all subjects to ensure attendance for medication administration. Weekly motivational enhancement counseling sessions will also be provided to all subjects. Study outcomes will consist of self-report and biological measures of alcohol use as well as measures of psychiatric symptom severity and medical service utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Active comparator | Drug: Naltrexone or PlaceboNaltrexone 50 mg per day, directly administered as 100 mg on Mondays, 100 mg on Wednesdays and 150 mg on Fridays |
| Lactose pill | Placebo comparator | Drug: Naltrexone or Placebo |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
- DSM-IV diagnosis of Alcohol Abuse or Alcohol Dependence;
- Level of Drinking: At least four days of drinking in the 30 days prior to consent;
- Currently prescribed antipsychotic medication;
- Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, St. Joseph's Hospital Health Center, VA Medical Center) or at another location in the community at the time of randomization.
Key exclusion criteria (13 listed)
- Inability to give adequate informed consent;
- Currently taking disulfiram (Antabuse) or naltrexone (ReVia/Depade);
- Current DSM-IV diagnosis of Opioid Dependence or Opioid Abuse;
- Currently taking ibuprofen or other potentially hepatotoxic medications in amount and/or frequency judged by the Principal Investigator to pose clinically significant added risk of hepatic injury;
- Current use of prescribed or non-prescribed opioid analgesics, such as methadone, morphine, codeine, heroin, meperidine, and all other opioids.
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 |
|---|---|---|
| Naltrexone or PlaceboNaltrexone or Placebo 50 mg per day | Drug | Lactose pill, Naltrexone |
Primary outcome
Measures of Alcohol Use
Time frame: 12 weeks
1 secondary outcome
Psychiatric Symptom Severity
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- BackgroundBatki SL, Dimmock JA, Leontieva L, Bowman ML, Gallinger L, Carey KB, Maisto SA, Canfield KM, McMaster T, Schweizer ML; (abstract) (2005) Recruitment and characteristics of alcohol dependent patients with schizophrenia. Alcoholism Clinical and Experimental Research 29 (5:suppl):78A (abstract 428)
- BackgroundBatki SL, Dimmock J, Hameed A, Cornell M, Wade M, Albrecht J, Maisto S, Carey K; (2001) Alcohol use measures in naltrexone treatment of alcohol dependence in schizophrenia: Preliminary analysis. Alcoholism Clinical and Experimental Research, 25 (5:suppl.):93A (abstract 522)
- BackgroundBatki SL, Dimmock J, Cornell M, Wade M, Carey K, Maisto S. (2002) Directly observed naltrexone treatment of alcohol dependence in schizophrenia: Preliminary analysis. Alcoholism Clinical and Experimental Research 26 (5:suppl.):83A (abstract 470)
- Background: PubMed 17661192Batki SL, Dimmock JA, Wade M, Gately PW, Cornell M, Maisto SA, Carey KB, Ploutz-Snyder R. Monitored naltrexone without counseling for alcohol abuse/dependence in schizophrenia-spectrum disorders. Am J Addict. 2007 Jul-Aug;16(4):253-9. doi: 10.1080/10550490701389732.
- Background: PubMed 19081784Carey KB, Leontieva L, Dimmock J, Maisto SA, Batki SL. Adapting Motivational Interventions for Comorbid Schizophrenia and Alcohol Use Disorders. Clin Psychol (New York). 2007 Mar;14(1):39-57. doi: 10.1111/j.1468-2850.2007.00061.x.
- BackgroundBatki, S. L., Dimmock, J. A., Leontieva, L., Bowman, M. L., Gallinger, L., Schweizer, M. L., Carey, K. B., Maisto, S. A., Canfield, K. M., McMaster, T., Ploutz-Snyder, R. (abstract) (2006). Associations among psychiatric symptoms, alcohol severity, and motivation to change in patients with schizophrenia and alcohol use disorders. American Journal on Addictions 15(4):321-322.
- BackgroundBatki, S.L., Dimmock, J.A., Leontieva, L., Bowman, M. L., Gallinger, L., Gately, P. W., Carey, K. B., Maisto, S. A., Canfield, K. M., Ploutz-Snyder, R. (abstract) (2006). Co-occurring substance use among patients with alcohol dependence and schizophrenia. Alcoholism Clinical and Experimental Research 30 (6: suppl.):162A (abstract 621)
- BackgroundCarey, K.B., Leontieva, L., Dimmock, J., Bowman, M., Gallinger, L., Gately, P., Maisto, S.A., Ploutz-Snyder, R., Batki, S.L. (abstract) (2006). Psychometrics of a short version of the problems assessment for substance-using psychiatric patients (PASSUP-SV) Alcoholism Clinical and Experimental Research 30(6: suppl.):206A (abstract 799)
- BackgroundLeontieva, L., Dimmock, J.A., Gately, P., Gallinger, L., Cavallerano, M., DeRycke, S., McMasters, T., Ploutz-Snyder, R., Strutynski, K., Carey, K.B., Maisto, S.A., & Batki, S.L.(abstract). Voucher-based incentives for adherence to research visits in schizophrenia and alcohol dependence.30th Annual Research Society on Alcoholism Meeting, Chicago, IL, USA, July, 2007
- Background: PubMed 18308913Leontieva L, Dimmock JA, Gately PW, Gallinger L, Ploutz-Snyder R, Batki SL. Voucher-based incentives for naltrexone treatment attendance in schizophrenia and alcohol use disorders. Psychiatr Serv. 2008 Mar;59(3):310-4. doi: 10.1176/ps.2008.59.3.310.
- SUNY Upstate Medical UniversityLink provided by the sponsor.
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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.
Steven L Batki, MD principal investigator
State University of New York - Upstate Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Schizophrenia and Mental Disorders, run by State University of New York - Upstate Medical University at 4 sites 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measures of Alcohol Use (time frame: 12 weeks). 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 NCT00145847, which also lists 10 linked publications.
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 8 Jan 2013.