HIV Counseling Intervention for Methadone-Maintained Patients - 2

This study has been completed.

First Received: May 21, 2003 Last Updated: October 15, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00061100

Purpose

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

Condition	Intervention	Phase
Opioid-Related Disorders	Behavioral: Behavior Therapy Behavioral: Education	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	HIV Counseling Intervention for Methadone-Maintained Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Methadone

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

AIDS risk behavior

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
1: Experimental Targeted RISK intervention	Behavioral: Behavior Therapy
2: Active Comparator Education intervention	Behavioral: Education 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, 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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061100

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Frances R Levin, M.D.

Research Foundation for Mental Hygiene, Inc.

More Information

No publications provided

Responsible Party:	NYSPI ( Frances R. Levin, M.D )
Study ID Numbers:	NIDA-011444-2, R01-DA011444-2, DPMCDA
Study First Received:	May 21, 2003
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00061100 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

ClinicalTrials.gov processed this record on November 05, 2009