Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI) (vivitrol)

March 17, 2008 updated by: State University of New York - Upstate Medical University

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI): A Pilot Study

The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as compared with oral naltrexone in reducing alcohol use from baseline levels

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall goal of this project is to improve the treatment of alcohol abuse and dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, bipolar type I disorder, major depressive disorder with psychotic features, or psychotic disorder not otherwise specified. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI such as schizophrenia. SUD comorbidity is associated with many adverse consequences. However, to date, few reports have addressed the efficacy of pharmacological treatments for SUDs 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 SMI. This pilot study plans to use a new intramuscular long-acting form of naltrexone that needs to be administered every 4 weeks compared to daily oral naltrexone, which we are also studying in this pilot. This could improve adherence to a medication regimen, which has been shown to be critical to successful naltrexone treatment of alcohol dependence. The proposed project is a 1-year pilot program of research. It is a randomized prospective parallel groups open-label trial of long-acting intramuscular (IM) naltrexone injected every 4 weeks compared to monthly prescriptions of oral naltrexone in a cohort of 20 subjects, ten for each treatment modality. The study is 16 weeks in duration, consisting of a 12-week course of naltrexone plus one follow-up interview at 4 weeks after discontinuation of medication. Voucher-based incentives are provided to all subjects to ensure attendance for medication administration. Weekly motivational counseling sessions are conducted and focus on improving motivation to stop alcohol use. Study outcomes consist of self-report and biological measures of alcohol use as well as measures of psychiatric symptom severity.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Major Depressive Disorder (MDD) with Psychotic features, Bipolar Type I or Type II Disorder, or Psychosis not Otherwise Specified (NOS) Disorder;
  2. DSM-IV diagnosis of Alcohol Dependence;

  3. Level of Drinking:

    1. At least four days of drinking in the 30 days prior to consent and/or during screening period OR
    2. For prospective subjects who are currently in an inpatient or residential facility or recently discharged within 30 days prior to consent: At least 4 days of drinking during the period of time immediately prior to inpatient admission and/or during post-discharge.
  4. Currently prescribed antipsychotic medications, mood stabilizers, or antidepressants.
  5. One negative urine screen for opiates prior to start of medication and a self-report of no opioid use for at least 1 week prior to starting medication.
  6. Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, SUNY Upstate Adult Psychiatric Clinic, St. Joseph's Hospital, VA Medical Center) or at another location in the community.

Exclusion Criteria:

  1. Inability to give adequate informed consent;
  2. Currently taking disulfiram (Antabuse), naltrexone, or acamprosate (Campral);
  3. Current DSM-IV diagnosis of Opioid Dependence;
  4. Current regular use of prescribed opioid analgesics, such as methadone, morphine, codeine, meperidine, and all other opioids. If the subject reports taking a prescribed opioid analgesic only occasionally, the study physician or nurse practitioner will contact the prescribing physician regarding the safety of study participation and the possibility of using an alternative. The principal investigator will make the final determination after obtaining the primary physician's recommendation regarding this criterion.
  5. Current daily use of non-prescribed opioids.
  6. 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;
  7. Female patients of childbearing potential who are sexually active, not sterile, and who deny using birth control;
  8. Female patients who are pregnant or nursing;
  9. 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;
  10. AST (aspartate aminotransferase test) levels: If AST is greater than 3x upper limit of normal;
  11. 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;
  12. In need of acute medical detoxification from alcohol in the judgment of the study physician based on results a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other information obtained;
  13. Scheduled surgery within 3 months of intake;
  14. Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary: Measures of Alcohol Use; Psychiatric Symptom Severity

Secondary Outcome Measures

Outcome Measure
adherence to medication, alcohol-related problems, quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Collaborators

Cephalon

Investigators

  • Principal Investigator: Steven L Batki, MD, SUNY Upstate Medical University, Psychiatry Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Batki, S.L., Dimmock, J.A., Cavallerano, M., Leontieva, L., DeRycke, S., Ploutz-Snyder, R., Gallinger, L., Strutynski, K., Canfield, K., Carey, K.B., Maisto, S.A., Keegan, P., McMaster, T. (under review) (poster presentation) A pilot trial of oral versus long-acting injectable naltrexone in serious mental illness. Research Society on Alcoholism, 30th Annual Scientific Meeting 2007

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Estimate)

March 18, 2008

Last Update Submitted That Met QC Criteria

March 17, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNY UMU IRB # 5371

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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