Buprenorphine HIV Care Integration Project

HIV Infection Clinical Trial

Official title:

Miami Buprenorphine HIV Care Integration Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348868
• Other study ID #: A007
• Status: Completed
• Phase: N/A
• First received: July 5, 2006
• Last updated: March 14, 2008
• Start date: July 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2007
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

DESIGN: 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.

DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.

SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.

POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.

STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)

INTERVENTON At entry subjects will be randomized to one of the following:

ARM A: Standard drug addiction counseling + buprenorphine / naloxone

ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone

The three primary outcomes are:

1. Cessation of illicit opioid use

2. Reduction in high risk behavior

3. Improved HIV therapy adherence

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• Opioid-Related Disorders

Intervention

Behavioral:
• enhanced behavioral motivation counseling

• Motivational counseling

• Standard counseling

Locations

Country	Name	City	State
United States	University of Miami AIDS Clinical Reserach Unit	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	HRSA/Maternal and Child Health Bureau, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence		week 48	No