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Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

Primary Purpose

Heroin Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Behavioral Naltrexone Therapy (BNT)
Compliance Enhancement (CE)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion: Adult, aged 18-60. 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. Able to give informed consent. At least one significant other is willing to be interviewed for possible participation in the treatment. Exclusion: Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. 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. 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. History of allergic reaction to naloxone, naltrexone, buprenorphine, clonidine, or clonazepam. Currently prescribed or regularly taking opiates for chronic pain or medical illness. Current participation in another intensive treatment program or currently prescribed psychotropic medications in the last 30 days. Current participation in a Methadone Maintenance program and/or regular and/or Dependent use of street methadone. Opiate-dependent individuals who are seeking methadone maintenance treatment. 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.

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CE plus oral naltrexone

BNT plus oral naltrexone

Arm Description

Compliance enhancement plus oral naltrexone

Behavioral naltrexone therapy plus oral naltrexone

Outcomes

Primary Outcome Measures

Relapse to heroin addiction

Secondary Outcome Measures

Full Information

First Posted
October 13, 2005
Last Updated
January 12, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00238914
Brief Title
Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
Official Title
Opiate Dependence: Combined Naltrexone/Behavior Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
July 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CE plus oral naltrexone
Arm Type
Active Comparator
Arm Description
Compliance enhancement plus oral naltrexone
Arm Title
BNT plus oral naltrexone
Arm Type
Active Comparator
Arm Description
Behavioral naltrexone therapy plus oral naltrexone
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
50mg of oral naltrexone daily
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Naltrexone Therapy (BNT)
Intervention Description
a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy
Intervention Type
Behavioral
Intervention Name(s)
Compliance Enhancement (CE)
Intervention Description
a controlled therapy intended to simulate outpatient psychiatric care.
Primary Outcome Measure Information:
Title
Relapse to heroin addiction
Time Frame
Up to 24 weeks or length of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Adult, aged 18-60. 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. Able to give informed consent. At least one significant other is willing to be interviewed for possible participation in the treatment. Exclusion: Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. 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. 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. History of allergic reaction to naloxone, naltrexone, buprenorphine, clonidine, or clonazepam. Currently prescribed or regularly taking opiates for chronic pain or medical illness. Current participation in another intensive treatment program or currently prescribed psychotropic medications in the last 30 days. Current participation in a Methadone Maintenance program and/or regular and/or Dependent use of street methadone. Opiate-dependent individuals who are seeking methadone maintenance treatment. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Nunes, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stars.columbia.edu
Description
Related Info

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Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

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