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

Tracking Information

First Received Date ^ICMJE

May 21, 2003

Last Updated Date

October 25, 2012

Start Date ^ICMJE

October 1999

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

AIDS risk behavior

Change History

Complete list of historical versions of study NCT00061100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

HIV Counseling Intervention for Methadone-Maintained Patients - 2

Official Title ^ICMJE

HIV Counseling Intervention for Methadone-Maintained Patients

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2003

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00061100

Other Study ID Numbers ^ICMJE

#3884, R01DA011444, 3884

Has Data Monitoring Committee

Responsible Party

New York State Psychiatric Institute

Study Sponsor ^ICMJE

New York State Psychiatric Institute

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Frances R Levin, M.D.

Research Foundation for Mental Hygiene, Inc.

Information Provided By

New York State Psychiatric Institute

Verification Date

October 2012

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

To Top