HIV Counseling Intervention for Methadone-Maintained Patients - 2

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00061100
First received: May 21, 2003
Last updated: October 25, 2012
Last verified: October 2012

May 21, 2003
October 25, 2012
October 1999
October 2003   (final data collection date for primary outcome measure)
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 ]
AIDS risk behavior
Complete list of historical versions of study NCT00061100 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HIV Counseling Intervention for Methadone-Maintained Patients - 2
HIV Counseling Intervention for Methadone-Maintained Patients

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Opioid-Related Disorders
  • Behavioral: Behavior Therapy-RISE
    manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
    Other Name: Behavior Therapy-RISE
  • Behavioral: Standard prevention Education
    standard psychosocial Education for HIV/hepatitis prevention
    Other Name: Standard prevention Education
  • Experimental: RISE intervention
    Targeted RISE intervention- Behavior therapy Rise
    Intervention: Behavioral: Behavior Therapy-RISE
  • Active Comparator: Standard Education
    Education intervention. Standard prevention education
    Intervention: Behavioral: Standard prevention Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2003
October 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061100
#3884, R01DA011444, 3884
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
New York State Psychiatric Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP