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Completed

NCT Number: NCT00061100

HIV Counseling Intervention for Methadone-Maintained Patients - 2

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

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Foundation for Mental Hygiene, Inc.

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavior Therapy-RISE

Behavioral

manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter

Standard prevention Education

Behavioral

standard psychosocial Education for HIV/hepatitis prevention

Primary outcomes

  1. AIDS risk behavior based on the Risk Behavior Assessment

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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

HIV Counseling Intervention for Methadone-Maintained Patients

Important dates

Study start
1999
Primary completion
2003
Study completion
2003
First posted
May 22, 2003
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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