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Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

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ClinicalTrials.gov Identifier: NCT00238914
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : January 13, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 14, 2005
Last Update Posted Date January 13, 2012
Study Start Date  ICMJE August 1999
Actual Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
Relapse to heroin addiction [ Time Frame: Up to 24 weeks or length of study participation ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
Relapse to heroin addiction
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
Official Title  ICMJE Opiate Dependence: Combined Naltrexone/Behavior Therapy
Brief Summary

The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:

  1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy.
  2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.
Detailed Description Long-term maintenance on naltrexone has proven efficacy as a treatment for opiate dependence, but has not been successful clinically because of at least three problems: 1) The transition from opiate to naltrexone precipitates opiate withdrawal unless the patient has been off any opiates for at least seven days; 2) Compliance issues: patients can miss a few naltrexone doses and begin to experience effects from illicit opiates and become re-addicted, at which point naltrexone cannot be restarted without precipitating withdrawal; 3) Naltrexone may produce dysphoria in some patients. The proposed research study will offer opiate dependent patients brief hospitalization for a rapid detoxification from opiate to naltrexone, using buprenorphine, clonidine and clonazepam. If the patient has already undergone detoxification at an outside unit, they will be assessed for opiate dependence using the naloxone challenge. Patients will then be either discharged or entered directly into outpatient treatment where they will be randomly assigned to either the newly developed "Behavioral Naltrexone Therapy" (BNT), a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy or to Compliance Enhancement (CE) therapy, a controlled therapy intended to simulate outpatient psychiatric care. BNT employs behavioral incentives and enlists members of the family and social network to reinforce naltrexone compliance and abstinence. In this current investigation, for both BNT and CE, all patients are maintained on oral naltrexone. Patients are stratified at baseline by presence or absence of lifetime depressive disorder, which the investigators hypothesize will predict dysphoria on naltrexone and non-compliance. Patients are discharged from the hospital, or entered directly, into outpatient treatment at STARS at NYSPI to receive both counseling and Naltrexone, 50 mg per day.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heroin Dependence
Intervention  ICMJE
  • Drug: Naltrexone
    50mg of oral naltrexone daily
  • Behavioral: Behavioral Naltrexone Therapy (BNT)
    a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy
  • Behavioral: Compliance Enhancement (CE)
    a controlled therapy intended to simulate outpatient psychiatric care.
Study Arms  ICMJE
  • Active Comparator: CE plus oral naltrexone
    Compliance enhancement plus oral naltrexone
    Interventions:
    • Drug: Naltrexone
    • Behavioral: Compliance Enhancement (CE)
  • Active Comparator: BNT plus oral naltrexone
    Behavioral naltrexone therapy plus oral naltrexone
    Interventions:
    • Drug: Naltrexone
    • Behavioral: Behavioral Naltrexone Therapy (BNT)
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: September 26, 2008)
12
Original Enrollment  ICMJE
 (submitted: October 13, 2005)
100
Actual Study Completion Date  ICMJE July 2002
Actual Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  1. Adult, aged 18-60.
  2. Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and further by a positive naloxone challenge test if the diagnosis is unclear.
  3. Able to give informed consent.
  4. At least one significant other is willing to be interviewed for possible participation in the treatment.

Exclusion:

  1. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
  2. Active medical illness which might make participation hazardous, such as untreated hypertension, unstable cardiovascular disease, acute hepatitis with SGOT or SGPT > 2-3 times normal, unstable diabetes, AIDS dementia.
  3. Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk of 1 or more suicide attempts within the past year.
  4. History of allergic reaction to naloxone, naltrexone, buprenorphine, clonidine, or clonazepam.
  5. Currently prescribed or regularly taking opiates for chronic pain or medical illness.
  6. Current participation in another intensive treatment program or currently prescribed psychotropic medications in the last 30 days.
  7. Current participation in a Methadone Maintenance program and/or regular and/or Dependent use of street methadone.
  8. Opiate-dependent individuals who are seeking methadone maintenance treatment.
  9. History of accidental drug overdose in the last three years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT00238914
Other Study ID Numbers  ICMJE #4260R
R01DA010746 ( U.S. NIH Grant/Contract )
R01-10746-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Edward Nunes, M.D. New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date January 2012

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