HIV Counseling Intervention for Methadone-Maintained Patients - 2

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

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

History of Changes

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 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:

MedlinePlus related topics: HIV/AIDS

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- 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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	New York State Psychiatric Institute
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on February 27, 2015

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