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

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ClinicalTrials.gov Identifier: NCT00453609
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : December 11, 2008
Sponsor:
Information provided by:
State University of New York - Upstate Medical University

Tracking Information
First Submitted Date  ICMJE March 27, 2007
First Posted Date  ICMJE March 29, 2007
Last Update Posted Date December 11, 2008
Study Start Date  ICMJE April 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2007)
feasibility: number recruited, visits attended
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00453609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
  • genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1)
  • alcohol use: self-report, biological measures, level of craving.
  • psychiatric functioning
  • neuropsychological functioning
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2007)
  • genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1)
  • alcohol use: self-report, biological measures, level of craving.
  • psychiatric functioning
  • well-being
  • neuropsychological functioning
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)
Official Title  ICMJE Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI): An Open Prospective Pilot Trial
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Alcohol Dependence
Intervention  ICMJE Drug: long-lasting injectable naltrexone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2008)
15
Original Enrollment  ICMJE
 (submitted: March 28, 2007)
30
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    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 (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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00453609
Other Study ID Numbers  ICMJE SUNY Upstate MU IRB # 5463
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE State University of New York - Upstate Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven L Batki, MD State University of New York - Upstate Medical University
PRS Account State University of New York - Upstate Medical University
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP