search
Back to results

Naltrexone Treatment of Alcohol Abuse in Schizophrenia

Primary Purpose

Schizophrenia, Mental Disorders, Alcohol Abuse

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naltrexone or Placebo
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring alcohol, schizophrenia, naltrexone

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • St. Joseph's Mental Health Services
  • Hutchings Psychiatric Center
  • SUNY Upstate Medical University
  • Veterans Administration Healthcare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naltrexone

Lactose pill

Arm Description

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

Outcomes

Primary Outcome Measures

Measures of Alcohol Use

Secondary Outcome Measures

Psychiatric Symptom Severity

Full Information

First Posted
September 1, 2005
Last Updated
January 7, 2013
Sponsor
State University of New York - Upstate Medical University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00145847
Brief Title
Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Official Title
Naltrexone Treatment of Alcohol Abuse in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Mental Disorders, Alcohol Abuse, Alcoholism, Alcohol-related Disorders
Keywords
alcohol, schizophrenia, naltrexone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone
Arm Type
Active Comparator
Arm Description
Naltrexone 50 mg per day, directly administered as 100 mg on Mondays, 100 mg on Wednesdays and 150 mg on Fridays
Arm Title
Lactose pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone or Placebo
Intervention Description
Naltrexone or Placebo 50 mg per day
Primary Outcome Measure Information:
Title
Measures of Alcohol Use
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Psychiatric Symptom Severity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Batki, MD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Mental Health Services
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
Hutchings Psychiatric Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Administration Healthcare Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
17661192
Citation
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.
Results Reference
background
PubMed Identifier
19081784
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
18308913
Citation
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.
Results Reference
background
Links:
URL
http://www.upstate.edu
Description
SUNY Upstate Medical University

Learn more about this trial

Naltrexone Treatment of Alcohol Abuse in Schizophrenia

We'll reach out to this number within 24 hrs