HIV Counseling Intervention for Methadone-Maintained Patients - 2

Phase 1

Completed

• Conditions: Opioid-Related Disorders

• Registration Number: NCT00061100
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.

Detailed Description

The purpose of this proposal is to evaluate, in methadone-maintained patients the association between an ADHD diagnosis and high-risk HIV/Hepatitis behavior. In addition, the investigators would like to determine whether a new manually-guided HIV intervention; RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard HIV/Hepatitis psycho-education.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2003-05-21
• Study First Submitted QC: 2003-05-21
• Study First Posted: 2003-05-22
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Must meet DSM-IV criteria for opiate dependence and currently in methadone maintenance treatment
• Able to give informed consent and capable of complying with study procedures
• Women who are of childbearing age and/or pregnant may be included
• Individuals who are HIV-positive or have Acquired Immunodeficiency Syndrome may be included
• Patients who demonstrate moderate to high HIV risk behaviors will be included
• Patients with low to no HIV risk behaviors will be excluded
• Patients receiving a stable dose of methadone for three weeks will be included

Exclusion Criteria

• Currently meets DSM-IV criteria for current Axis I psychiatric disorders (other than ADHD or substance abuse) which requires medical intervention, i.e., active suicide ideation, active psychosis, anxiety disorders, depression requiring hospitalization
• Patients who have exhibited suicidal or homicidal behavior within the past two years
• HIV positive patients must have knowledge of their status for a minimum of three weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AIDS risk behavior based on the Risk Behavior Assessment	assessed monthly during 2 months of study or length of participation

Trial Locations

Locations (1)

Research Foundation for Mental Hygiene, Inc.; 🇺🇸 New York, New York, United States