Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Information source: State University of New York - Upstate Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Mental Disorders; Alcohol Abuse; Alcoholism; Alcohol-related Disorders
Intervention: Naltrexone or Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: State University of New York - Upstate Medical University Official(s) and/or principal investigator(s): Steven L Batki, MD, Principal Investigator, Affiliation: State University of New York - Upstate Medical University
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.
Clinical Details
Official title: Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Measures of Alcohol Use
Secondary outcome: Psychiatric Symptom Severity
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
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.
Locations and Contacts
Hutchings Psychiatric Center, Syracuse, New York 13210, United States
St. Joseph's Mental Health Services, Syracuse, New York 13203, United States
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Veterans Administration Healthcare Center, Syracuse, New York 13210, United States
Additional Information
SUNY Upstate Medical University
Related 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. 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. 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. 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/appi.ps.59.3.310.
Starting date: April 2003
Last updated: January 7, 2013
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