HIV Counseling Intervention for Methadone-Maintained Patients - 2

Phase 1

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Behavioral: Behavior Therapy-RISE; Behavioral: Standard prevention Education

• 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

Arm && Interventions

Group	Intervention	Description
RISE intervention	Behavior Therapy-RISE	Targeted RISE intervention- Behavior therapy Rise
Standard Education	Standard prevention Education	Education intervention. Standard prevention education

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