Naltrexone Treatment of Alcohol Abuse in Schizophrenia

NCT ID: NCT00145847

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-05-31

Brief 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.

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.

Conditions

Schizophrenia; Mental Disorders; Alcohol Abuse; Alcoholism; Alcohol-related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naltrexone

Naltrexone 50 mg per day, directly administered as 100 mg on Mondays, 100 mg on Wednesdays and 150 mg on Fridays

Group Type: ACTIVE_COMPARATOR

Naltrexone or Placebo

Intervention Type: DRUG

Naltrexone or Placebo 50 mg per day

Lactose pill

Group Type: PLACEBO_COMPARATOR

Naltrexone or Placebo

Intervention Type: DRUG

Naltrexone or Placebo 50 mg per day

Interventions

Naltrexone or Placebo

Naltrexone or Placebo 50 mg per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;

2. DSM-IV diagnosis of Alcohol Abuse or Alcohol Dependence;

3. Level of Drinking: At least four days of drinking in the 30 days prior to consent;

4. Currently prescribed antipsychotic medication;

5. 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.

Exclusion Criteria

1. Inability to give adequate informed consent;

2. Currently taking disulfiram (Antabuse) or naltrexone (ReVia/Depade);

3. Current DSM-IV diagnosis of Opioid Dependence or Opioid Abuse;

4. 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;

5. Current use of prescribed or non-prescribed opioid analgesics, such as methadone, morphine, codeine, heroin, meperidine, and all other opioids.

6. Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control;

7. Female patients who are pregnant or nursing;

8. 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;

9. AST levels greater than 3x upper limit of normal;

10. 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;

11. 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;

12. Scheduled surgery within 3 months of intake;

13. Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Steven Batki, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven L Batki, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

St. Joseph's Mental Health Services

Syracuse, New York, United States

Hutchings Psychiatric Center

Syracuse, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Veterans Administration Healthcare Center

Syracuse, New York, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

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)

Reference Type: BACKGROUND

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)

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17661192 (View on PubMed)

Carey 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.

Reference Type: BACKGROUND

PMID: 19081784 (View on PubMed)

Batki, 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.

Reference Type: BACKGROUND

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)

Reference Type: BACKGROUND

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)

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18308913 (View on PubMed)

Related Links

http://www.upstate.edu

SUNY Upstate Medical University

Other Identifiers

1R01AA013655-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SUNY UMU IRB # 4800

Identifier Type: -

Identifier Source: org_study_id