HIV Counseling Intervention for Methadone-Maintained Patients - 2

This study has been completed.

First Received on May 21, 2003. Last Updated on December 6, 2011 History of Changes

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	Frances R Levin, New York State Psychiatric Institute
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-RISE Behavioral: Standard prevention Education	Phase I

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

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	Behavioral: Behavior Therapy-RISE manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
Active Comparator: Standard Education Education intervention	Behavioral: Standard prevention Education standard psychosocial Education for HIV/hepatitis prevention

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.

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

New York State Psychiatric Institute

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:	Frances R Levin, Kennedy-Leavy Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00061100 History of Changes
Other Study ID Numbers:	NIDA-011444-2, R01DA011444, 3884
Study First Received:	May 21, 2003
Last Updated:	December 6, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012