Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
2 other identifiers
interventional
125
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2002
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 30, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedOctober 26, 2012
October 1, 2012
5.5 years
May 30, 2006
October 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
proportion of patients relapsing to illicit opiates based on urine toxicology and self report.
proportion of patients relapsing to opiate use
over 6 months of trial or length of participation
proportion of patients retained in treatment
proportion of patients retained over the course of the trial
over course of 6 months of trial
Study Arms (4)
CE plus oral +depot naltrexone
ACTIVE COMPARATORCompliance enhancement (CE), simulating standard treatment with oral naltrexone plus two depot naltrexone;
CE plus oral naltrexone+ placebo
PLACEBO COMPARATORCE with oral naltrexone plus two placebo injections
BNT plus Depot naltrexone
EXPERIMENTALBNT plus two doses of depot naltrexone prior to hospital discharge
BNT plus PBO injection
PLACEBO COMPARATORBNT plus two placebo injections
Interventions
long-acting depot parenteral formulation of naltrexone
Compliance enhancement (CE), simulating standard treatment with oral naltrexone
behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
Eligibility Criteria
You may qualify if:
- Adult, aged 18-60. Clinical Interview.
- 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.
- Able to give informed consent. Clinical interview and mental status exam
- 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.
You may not qualify if:
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Clinical Interview, physical examination, serum pregnancy test
- 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
- 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.
- History of allergic reaction to buprenorphine, naloxone, naltrexone, clonidine, or clonazepam.
- Clinical Interview
- Currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Clinical Interview
- Current participation in another intensive substance abuse treatment program.
- Clinical Interview
- Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (\>30 mg per week). Clinical Interview; Urine toxicology.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
New York State Psychiatric Institute
New York, New York, 10032, United States
STARS
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Nunes, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2006
First Posted
June 1, 2006
Study Start
June 1, 2002
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
October 26, 2012
Record last verified: 2012-10