NCT00757744

Brief Summary

A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with methadone maintenance treatment in Wuhan, China

Trial Health

90
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

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, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 30, 2020

Status Verified

May 1, 2011

Enrollment Period

2.3 years

First QC Date

September 22, 2008

Last Update Submit

March 27, 2020

Conditions

Opiate DependenceHIV Infections

Keywords

drug counselingHIV risksmethadone maintenanceHIV Seronegativity

Outcome Measures

Primary Outcomes (2)

  • Reductions of illicit opiate use

    6 months

  • Reductions in HIV risk behaviors

    6 months

Study Arms (2)

A

EXPERIMENTAL

Methadone maintenance treatment with Behavioral Drug and HIV Risk Reduction Counseling (BDRC)

Behavioral: Behavioral Drug and HIV Risk Reduction Counseling (BDRC)

B

ACTIVE COMPARATOR

Methadone maintenance treatment with standard drug counseling

Behavioral: Drug counseling

Interventions

Behavioral Drug and HIV Risk Reduction Counseling (BDRC)BEHAVIORAL

once weekly individual counseling

A
Drug counselingBEHAVIORAL

individual drug counseling

B

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opioid dependence

You may not qualify if:

  • current dependence on alcohol, benzodiazepines or sedatives
  • current suicide or homicide risk
  • current psychotic disorder or untreated major depression
  • life-threatening or unstable medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University School of Medicine - CMHC

New Haven, Connecticut, 06520, United States

Location

Wuhan Center for Disease Control and Prevention

Wuhan, Hubei, China

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

  • Richard S Schottenfeld, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

September 1, 2007

Primary Completion

January 1, 2010

Study Completion

September 1, 2010

Last Updated

March 30, 2020

Record last verified: 2011-05

Locations

US(1)CN(1)