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Clinical Trials/NCT00061100
NCT00061100
Completed
Phase 1

HIV Counseling Intervention for Methadone-Maintained Patients

New York State Psychiatric Institute1 site in 1 country50 target enrollmentOctober 1999

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Opioid-Related Disorders
Sponsor
New York State Psychiatric Institute
Enrollment
50
Locations
1
Primary Endpoint
AIDS risk behavior based on the Risk Behavior Assessment
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1999
End Date
October 2003
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Frances R Levin

Director of Substance Use Disorder

New York State Psychiatric Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

AIDS risk behavior based on the Risk Behavior Assessment

Time Frame: assessed monthly during 2 months of study or length of participation

Study Sites (1)

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