NCT00406484

Brief Summary

A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) and standard methadone drug counseling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

September 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

November 30, 2006

Last Update Submit

March 31, 2020

Conditions

Opiate DependenceHIV Infections

Keywords

MethadoneCounselingHIV risk reductionHIV Seronegativity

Outcome Measures

Primary Outcomes (3)

  • Maximum number of consecutive weeks of opiate abstinence achieved during treatment

    12 weeks

  • Overall proportion of opiate negative urines tests in each treatment group

    12 weeks

  • Reduction in HIV risk behaviors

    12 weeks

Secondary Outcomes (1)

  • Improvements in social, employment, legal, medical and psychiatric functioning

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Behavioral Drug and HIV Risk Reduction Counseling (BDRC)

Behavioral: BDRC

2

ACTIVE COMPARATOR

Standard drug counseling

Behavioral: Standard drug counseling

Interventions

Standard drug counselingBEHAVIORAL

Individual drug counseling

2
BDRCBEHAVIORAL

Behavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opioid dependence

You may not qualify if:

  • suicide or homicide risk
  • psychiatric disorder requiring medication treatment
  • life threatening or unstable medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Methadone Research Unit, The APT Foundation, Inc.

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersHIV Infections

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Marek C Chawarski, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

September 1, 2004

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

US(2)