NCT00238914

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:

  1. 1.Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy.
  2. 2.Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

October 13, 2005

Last Update Submit

January 12, 2012

Conditions

Heroin Dependence

Outcome Measures

Primary Outcomes (1)

  • Relapse to heroin addiction

    Up to 24 weeks or length of study participation

Study Arms (2)

CE plus oral naltrexone

ACTIVE COMPARATOR

Compliance enhancement plus oral naltrexone

Drug: NaltrexoneBehavioral: Compliance Enhancement (CE)

BNT plus oral naltrexone

ACTIVE COMPARATOR

Behavioral naltrexone therapy plus oral naltrexone

Drug: NaltrexoneBehavioral: Behavioral Naltrexone Therapy (BNT)

Interventions

NaltrexoneDRUG

50mg of oral naltrexone daily

BNT plus oral naltrexoneCE plus oral naltrexone
Behavioral Naltrexone Therapy (BNT)BEHAVIORAL

a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy

BNT plus oral naltrexone
Compliance Enhancement (CE)BEHAVIORAL

a controlled therapy intended to simulate outpatient psychiatric care.

CE plus oral naltrexone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Heroin Dependence

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Edward Nunes, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 14, 2005

Study Start

August 1, 1999

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

January 13, 2012

Record last verified: 2012-01

Locations

US(1)