NCT00348868

Brief Summary

A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 18, 2008

Status Verified

April 1, 2007

Enrollment Period

1.4 years

First QC Date

July 5, 2006

Last Update Submit

March 14, 2008

Conditions

HIV InfectionOpioid-Related Disorders

Keywords

HIV InfectionOpioid dependenceDSM-IV criteria for opioid dependence

Outcome Measures

Primary Outcomes (1)

  • The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence

    week 48

Study Arms (2)

1

EXPERIMENTAL

enhanced behavioral motivation counseling

Behavioral: enhanced behavioral motivation counselingBehavioral: Motivational counseling

2

ACTIVE COMPARATOR
Behavioral: Standard counseling

Interventions

enhanced behavioral motivation counselingBEHAVIORAL
1
Motivational counselingBEHAVIORAL
1
Standard counselingBEHAVIORAL
2

Eligibility Criteria

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

You may qualify if:

  • HIV infection
  • Receiving or seeking outpatient HIV care
  • Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine
  • Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given
  • Men and women age ≥ 18 years
  • Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine
  • Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase \<=5 X ULN, Total bilirubin \<= 2.5 x ULN

You may not qualify if:

  • Serious medical problem
  • Acute and/or severe psychiatric conditions
  • High dose methadone (\>30 mg/day)
  • Documented co-dependence on alcohol and/or benzodiazepines, barbiturates
  • Chronic pain management requiring opioids
  • Pregnancy or breast-feeding
  • Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami AIDS Clinical Reserach Unit

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

HIV InfectionsOpioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Margaret Fischl, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 18, 2008

Record last verified: 2007-04

Locations

US(1)