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

Condition	Treatment or Intervention	Phase
Opioid-Related Disorders	Behavior: Behavior Therapy	Phase I

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, we 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   -   60 Years,  Genders Eligible for Study:  Both

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

Frances R Levin, M.D.      (212)960-5896    fr12@columbia.edu

New York
      Research Foundation for Mental Hygiene, Inc., New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

Frances R Levin, M.D.,  Principal Investigator,  Research Foundation for Mental Hygiene, Inc.   

Study ID Numbers:  NIDA-11444-2; R01-11444-2
Record last reviewed:  July 2003
Record first received:  May 21, 2003
ClinicalTrials.gov Identifier:  NCT00061100
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08