Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00238914
First received: October 13, 2005
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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.

Condition Intervention Phase
Heroin Dependence
Drug: Naltrexone
Behavioral: Behavioral Naltrexone Therapy (BNT)
Behavioral: Compliance Enhancement (CE)
Phase 2

New York State Psychiatric Institute has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Opiate Dependence: Combined Naltrexone/Behavior Therapy

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Relapse to heroin addiction [ Time Frame: Up to 24 weeks or length of study participation ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 1999
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CE plus oral naltrexone
Compliance enhancement plus oral naltrexone
Drug: Naltrexone
50mg of oral naltrexone daily
Behavioral: Compliance Enhancement (CE)
a controlled therapy intended to simulate outpatient psychiatric care.
Active Comparator: BNT plus oral naltrexone
Behavioral naltrexone therapy plus oral naltrexone
Drug: Naltrexone
50mg of oral naltrexone daily
Behavioral: Behavioral Naltrexone Therapy (BNT)
a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238914

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Edward Nunes, M.D. New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00238914     History of Changes
Other Study ID Numbers: #4260R, R01DA010746, R01-10746-1
Study First Received: October 13, 2005
Last Updated: January 12, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014