Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
NCT ID: NCT00332228
Last Updated: 2012-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2002-06-30
2007-12-31
Brief Summary
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Detailed Description
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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 Preliminary work with a new depot formulation of naltrexone was conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection.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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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CE plus oral +depot naltrexone
Compliance enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone;
depot naltrexone
long-acting depot parenteral formulation of naltrexone
Compliance enhancement (CE)
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
CE plus oral naltrexone+ placebo
CE with oral naltrexone plus two placebo injections
Compliance enhancement (CE)
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
BNT plus Depot naltrexone
BNT plus two doses of depot naltrexone prior to hospital discharge
depot naltrexone
long-acting depot parenteral formulation of naltrexone
BNT
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
BNT plus PBO injection
BNT plus two placebo injections
BNT
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
Interventions
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depot naltrexone
long-acting depot parenteral formulation of naltrexone
Compliance enhancement (CE)
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
BNT
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Edward Nunes, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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New York State Psychiatric Institute
New York, New York, United States
STARS
New York, New York, United States
Countries
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Related Links
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serive website
Other Identifiers
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5004-R
Identifier Type: -
Identifier Source: org_study_id