NCT00591617

Brief Summary

Building on a platform of pharmacological treatment with Suboxone (buprenorphine and naloxone), participants are randomly assigned to one of four psychosocial treatment conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

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

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

5.3 years

First QC Date

December 28, 2007

Last Update Submit

January 28, 2013

Conditions

Opioid Dependency

Keywords

Opioidsdrug dependencedrug abusetreatment

Outcome Measures

Primary Outcomes (1)

  • Comparison the effectiveness of four psychosocial treatment conditions as measured by self-reported abstinence from opioids verified by urine toxicology tests

    Week 18 - At end of first phase

Secondary Outcomes (3)

  • Comparison across treatment conditions for reducing the severity of opioid-related problems

    at end of Phase 1 (wk 18), phase 2 (wk 34) and two follow-up timepoints (wks. 40 and 52)

  • Comparison across treatment conditions for reducing the proportion of use-days of other substances of abuse (alcohol, marijuana, amphetamines, methamphetamines, benzodiazepines and barbiturates) as determined by self-report and urine test results.

    At end of Phase 1 (wk. 18), Phase 2 (wk. 34), and at two follow-ups (wks. 40 and 52)

  • Comparison across treatment conditions in reducing psychiatric and mood disturbance as measured with the BDI and SF-36.

    At end of Phase 1 (wk. 18), Phase 2 (wk. 34), and at two follow-ups (wks. 40 and 52)

Study Arms (4)

1: MM

ACTIVE COMPARATOR

Medical Management: group receives medical management from study physician and Suboxone pharmacotherapy

Other: Psychosocial treatment plus Suboxone pharmacotherapy

2: CBT

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) group receives CBT, medical management and Suboxone pharmacotherapy

Other: Psychosocial treatment plus Suboxone pharmacotherapy

3: CM

ACTIVE COMPARATOR

Contingency Management (CM) group receives CM, medical management, and Suboxone pharmacotherapy

Other: Psychosocial treatment plus Suboxone pharmacotherapy

4: CBT + CM

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) and Contingency Management (CM) group receives CBT, CM, medical management, and Suboxone pharmacotherapy

Other: Psychosocial treatment plus Suboxone pharmacotherapy

Interventions

Psychosocial treatment plus Suboxone pharmacotherapyOTHER

Participants randomly assigned to one of four psychosocial treatment conditions building on pharmacotherapy with Suboxone (buprenorphine + naloxone)

1: MM2: CBT3: CM4: CBT + CM

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must:
  • Be 15 years of age or older.
  • Meet DSM-IV-TR criteria for opioid dependence.
  • Be interested in receiving buprenorphine treatment for their opioid dependence.
  • Be in good general health or, in case of a medical/psychiatric condition needing ongoing treatment, be under the care of a physician who provides documented willingness to continue participant's medical management and coordinate care with the study physicians. \*
  • Be agreeable to and capable of signing an informed consent.
  • Have means of reliable transportation over the study period.
  • If female and of child bearing potential, agree to use of one of the following methods of birth control or be surgically sterile:
  • oral contraceptives
  • patch
  • barrier (diaphragm or condom)
  • intrauterine contraceptive system
  • levonorgestrel implant
  • medroxyprogesterone acetate contraceptive injection
  • complete abstinence from sexual intercourse
  • +2 more criteria

You may not qualify if:

  • Participants must not:
  • Have a known sensitivity to buprenorphine or naloxone.
  • Be dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention.
  • Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease).
  • Have a current pattern of benzodiazepine use, as assessed by the study physician, which would preclude safe participation in the study.
  • Be actively involved in another clinical trial.
  • Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk.
  • Be a nursing or pregnant female. Females who become pregnant during the course of the study will be withdrawn from the study and referred to an appropriate treatment venue; i.e. narcotic treatment program or specialty addiction clinic.
  • Be a female of childbearing potential who does not agree to use a medically acceptable method of birth control, e.g. oral contraceptives, barrier (diaphragm or condom) with or without spermicide, levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection, or complete abstinence.
  • Have any pending legal action that could prohibit continued participation for the one-year period of study participation (such as that which could possibly result in incarceration).
  • Be expecting to leave the clinic's geographic area prior to study completion (within one year).
  • Have been previously randomized to a treatment condition in this study. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center

Los Angeles, California, 90025, United States

Location

Related Publications (2)

  • McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529.

    PMID: 40833692DERIVED

  • Nielsen S, Hillhouse M, Mooney L, Fahey J, Ling W. Comparing buprenorphine induction experience with heroin and prescription opioid users. J Subst Abuse Treat. 2012 Oct;43(3):285-90. doi: 10.1016/j.jsat.2011.12.009. Epub 2012 Feb 1.

    PMID: 22301084DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Walter Ling, M.D.

    UCLA Integrated Substance Abuse Programs

    PRINCIPAL INVESTIGATOR

  • Maureen Hillhouse, Ph.D.

    UCLA Integrated Substance Abuse Programs

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 11, 2008

Study Start

September 1, 2006

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

US(1)