Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)

Last updated: December 10, 2008
Sponsor: State University of New York - Upstate Medical University
Overall Status: Completed

Phase

4

Condition

Substance Abuse

Mood Disorders

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT00453609
SUNY Upstate MU IRB # 5463
  • Ages 18-69
  • All Genders

Study Summary

The overall goal of this project is to improve the treatment of alcohol 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, and bipolar type I or type II disorder. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI. 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. 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 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 in reducing alcohol use from baseline levels.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. DSM-IV diagnosis of Alcohol Dependence in the last 12 months.

  3. Level of Drinking:

  4. At least four days of drinking in the 30 days prior to consent and/or duringscreening period OR

  5. For prospective subjects who are currently in an inpatient or residentialfacility or recently discharged within 30 days prior to consent: At least 4 daysof drinking during the period of time immediately prior to inpatient admissionand/or during post-discharge.

  6. Currently prescribed antipsychotic medications, mood stabilizers, or antidepressants.

  7. One negative urine screen for opiates prior to start of medication and a self-reportof no opioid use for at least 1 week prior to starting medication.

  8. Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, SUNY Upstate Adult Psychiatric Clinic, St. Joseph'sHospital, VA Medical Center) or at another location in the community.

Exclusion

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 (criteria met in the last month);

  4. Current regular use of prescribed opioid analgesics, such as methadone, morphine,codeine, meperidine, and all other opioids. If the subject reports taking a prescribedopioid analgesic only occasionally, the study physician or nurse practitioner willcontact the prescribing physician regarding the safety of study participation and thepossibility of using an alternative. The principal investigator will make the finaldetermination after obtaining the primary physician's recommendation regarding thiscriterion.

  5. Current daily use of non-prescribed opioids.

  6. Currently taking ibuprofen or other potentially hepatotoxic medications in amountand/or frequency judged by the Principal Investigator to pose clinically significantadded risk of hepatic injury;

  7. Female patients of childbearing potential who are sexually active, not sterile, andwho deny using birth control;

  8. Female patients who are pregnant or nursing;

  9. Significant unstable medical problems, including any significant unstable psychiatricdisorders. The study physician conducting the medical history and physical exam willexclude such clinically unstable individuals;

  10. AST (aspartate aminotransferase test) levels: If AST is greater than 3x upper limit ofnormal;

  11. Subjects who do not attend required screening appointments. Subsequent exclusion fromthe study for reasons related to non-attendance will be based on the judgment of theprincipal investigator;

  12. In need of acute medical detoxification from alcohol in the judgment of the studyphysician based on results a score of 12 or more on the Clinical Institute WithdrawalAssessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other informationobtained;

  13. Scheduled surgery within 3 months of intake;

  14. Subjects who have pending legal proceedings whose outcome may lead to incarcerationwithin 3 months.

Study Design

Total Participants: 15
Study Start date:
April 01, 2007
Estimated Completion Date:
October 31, 2008

Study Description

The proposed project is a 1-year pilot program of research, which will examine the feasibility of a new, intramuscular (IM) long-acting form of naltrexone. The long-acting form of naltrexone may improve medication adherence, which has been shown to be critical to successful naltrexone treatment of alcohol dependence. The study is a 16-week, randomized, prospective, open-label trial, including a 12-week course of monthly naltrexone injections. A follow-up interview will be conducted 4 weeks after discontinuation of medication. Thirty subjects will be recruited. Voucher-based incentives will be provided to all subjects to ensure attendance for medication administration. Weekly motivational counseling sessions will be conducted and will focus on improving motivation to stop alcohol use. Study outcomes consist of self-report and biological measures of alcohol use; measures of psychiatric symptom severity and neurocognitive functioning; and genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1), which may predict response to naltrexone treatment.

Connect with a study center

  • Hutchings Psychiatric Center

    Syracuse, New York 13210
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • St. Joseph's Mental Health Services

    Syracuse, New York 13203
    United States

    Site Not Available

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