HIV Counseling Intervention for Methadone-Maintained Patients - 2

This study has been completed.
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: May 21, 2003
Last updated: October 25, 2012
Last verified: October 2012

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

Condition Intervention Phase
Opioid-Related Disorders
Behavioral: Behavior Therapy-RISE
Behavioral: Standard prevention Education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Counseling Intervention for Methadone-Maintained Patients

Resource links provided by NLM:

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • AIDS risk behavior based on the Risk Behavior Assessment [ Time Frame: assessed monthly during 2 months of study or length of participation ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 1999
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RISE intervention
Targeted RISE intervention- Behavior therapy Rise
Behavioral: Behavior Therapy-RISE
manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
Other Name: Behavior Therapy-RISE
Active Comparator: Standard Education
Education intervention. Standard prevention education
Behavioral: Standard prevention Education
standard psychosocial Education for HIV/hepatitis prevention
Other Name: Standard prevention Education

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00061100

United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute Identifier: NCT00061100     History of Changes
Other Study ID Numbers: #3884, R01DA011444, 3884
Study First Received: May 21, 2003
Last Updated: October 25, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders processed this record on March 26, 2015