Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00332228
First received: May 30, 2006
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence. This study includes free detox and outpatient treatment for opioid dependence that includes medication and a behavioral intervention.


Condition Intervention Phase
Opiate Dependence
Drug: depot naltrexone
Behavioral: Compliance enhancement (CE)
Drug: BNT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • proportion of patients relapsing to illicit opiates based on urine toxicology and self report. [ Time Frame: over 6 months of trial or length of participation ] [ Designated as safety issue: No ]
    proportion of patients relapsing to opiate use

  • proportion of patients retained in treatment [ Time Frame: over course of 6 months of trial ] [ Designated as safety issue: No ]
    proportion of patients retained over the course of the trial


Enrollment: 125
Study Start Date: June 2002
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CE plus oral +depot naltrexone
Compliance enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone;
Drug: depot naltrexone
long-acting depot parenteral formulation of naltrexone
Other Name: depot naltrexone
Behavioral: Compliance enhancement (CE)
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
Other Name: Compliance enhancement (CE)
Placebo Comparator: CE plus oral naltrexone+ placebo
CE with oral naltrexone plus two placebo injections
Behavioral: Compliance enhancement (CE)
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
Other Name: Compliance enhancement (CE)
Experimental: BNT plus Depot naltrexone
BNT plus two doses of depot naltrexone prior to hospital discharge
Drug: depot naltrexone
long-acting depot parenteral formulation of naltrexone
Other Name: depot naltrexone
Drug: BNT
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
Other Name: BNT
Placebo Comparator: BNT plus PBO injection
BNT plus two placebo injections
Drug: BNT
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
Other Name: BNT

Detailed Description:

The goal of this Stage II project is to test the efficacy of a new combination of behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction, and to test a new long-acting depot parenteral formulation of naltrexone in initiating treatment.

  1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy. Hypotheses:
  2. Injections of depot naltrexone will reduce early attrition, improve initial stabilization on oral naltrexone, and improve long-term outcome, particularly when combined with Behavioral Naltrexone Therapy.
  3. Patients who exhibit escalating levels of commitment language strength throughout one early session of BNT will remain in treatment longer, will take more doses of naltrexone, and will provide a higher percentage of opiate-free urines.
  4. Increased commitment language strength on the part of the SO monitor will contribute independently to the outcome of the identified patient, when controlling for patient level commitment.

A critical objective of this current proposal is to improve retention, particularly in the initial weeks of treatment. Preliminary work with a new depot formulation of naltrexone was conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection. By removing the option of stopping naltrexone to sample heroin, a common mode of relapse, we hope to prevent early attrition and fully expose all patients to the behavioral regimen of BNT, intended to shape strong compliance with oral naltrexone and motivation for abstinence and lifestyle change.

160 heroin-dependent individuals seeking treatment will be recruited at PI (STARS) or referred from other sites (e.g., private physician; other detoxification programs). Prospective patients will be offered hospitalization for detoxification for rapid transition to naltrexone followed by outpatient naltrexone maintenance and counseling for six months. All enrolled participants will be encouraged to return for follow-up assessment visits at one, three, and six months beyond the completion of their participation for research purposes.

Patients will be randomly assigned to either the newly developed BNT or Compliance Enhancement Therapy (CET), a manual-guided approach developed by Carroll and O'Malley at Yale University as a control condition for psychotherapy studies with substance dependent patients. Patients will also be randomly assigned to receive either active or placebo injections of depot naltrexone prior to discharge from the detoxification. Therefore, there will be four treatment conditions with 40 participants per condition. These four conditions include: 1) BNT plus two doses of depot naltrexone prior to hospital discharge; 2) BNT plus two placebo injections; 3) Compliance Enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone injections; and 4) CE plus two placebo injections.

  Eligibility

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

Inclusion Criteria:

  1. Adult, aged 18-60. Clinical Interview.
  2. Meets DSM-IV criteria for current opiate dependence disorder, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.

    Clinical and SCID interview. Urine toxicology. Naloxone Challenge (see Procedures) Communication with former treatment provider.

  3. Able to give informed consent. Clinical interview and mental status exam
  4. There must be one qualified significant other who is willing to be interviewed and participate in program in order for a subject to be included in the study.

Clinical interview, and statement by significant other.

Exclusion Criteria:

  1. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.

    Clinical Interview, physical examination, serum pregnancy test

  2. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels >2-3 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).

    Clinical Interview, physical examination, laboratory (Chem-20, CBC, urinalysis), ECG

  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 or 1 or more suicide attempts within the past year.

    Clinical and SCID interview, clinical mental status examination, discussions with previous psychiatrist or treatment provider if formerly in treatment.

  4. History of allergic reaction to buprenorphine, naloxone, naltrexone, clonidine, or clonazepam.

    Clinical Interview

  5. Currently prescribed or regularly taking opiates for chronic pain or medical illness.

    Clinical Interview

  6. Current participation in another intensive substance abuse treatment program.

    Clinical Interview

  7. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week). Clinical Interview; Urine toxicology.
  8. Only available significant other is an active substance abuser, has an active psychiatric or medical illness which would interfere with participation (e.g., chronic psychosis, depression with suicide risk), or has a history of significant physical violence with the participant.

    Clinical Interview

  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.

Clinical Interview

  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: NCT00332228

Locations
United States, New York
STARS
New York, New York, United States, 10032
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, MD Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00332228     History of Changes
Other Study ID Numbers: 5004-R, R01DA010746
Study First Received: May 30, 2006
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
opiate dependence
heroin dependence
naltrexone
cognitive behavioral therapy

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

ClinicalTrials.gov processed this record on July 26, 2014