- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238914
Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
January 12, 2012 updated by: New York State Psychiatric Institute
Opiate Dependence: Combined Naltrexone/Behavior Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CE plus oral naltrexone
Compliance enhancement plus oral naltrexone
|
50mg of oral naltrexone daily
a controlled therapy intended to simulate outpatient psychiatric care.
|
Active Comparator: BNT plus oral naltrexone
Behavioral naltrexone therapy plus oral naltrexone
|
50mg of oral naltrexone daily
a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse to heroin addiction
Time Frame: Up to 24 weeks or length of study participation
|
Up to 24 weeks or length of study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Edward Nunes, M.D., New York State Psychiatric Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1999
Primary Completion (Actual)
July 1, 2002
Study Completion (Actual)
July 1, 2002
Study Registration Dates
First Submitted
October 13, 2005
First Submitted That Met QC Criteria
October 13, 2005
First Posted (Estimate)
October 14, 2005
Study Record Updates
Last Update Posted (Estimate)
January 13, 2012
Last Update Submitted That Met QC Criteria
January 12, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #4260R
- R01DA010746 (U.S. NIH Grant/Contract)
- R01-10746-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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