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HIV Counseling Intervention for Methadone-Maintained Patients - 2

Primary Purpose

Opioid-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy-RISE
Standard prevention Education
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-Related Disorders focused on measuring HIV, methadone maintenance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RISE intervention

Standard Education

Arm Description

Targeted RISE intervention- Behavior therapy Rise

Education intervention. Standard prevention education

Outcomes

Primary Outcome Measures

AIDS risk behavior based on the Risk Behavior Assessment

Secondary Outcome Measures

Full Information

First Posted
May 21, 2003
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00061100
Brief Title
HIV Counseling Intervention for Methadone-Maintained Patients - 2
Official Title
HIV Counseling Intervention for Methadone-Maintained Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
HIV, methadone maintenance

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RISE intervention
Arm Type
Experimental
Arm Description
Targeted RISE intervention- Behavior therapy Rise
Arm Title
Standard Education
Arm Type
Active Comparator
Arm Description
Education intervention. Standard prevention education
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy-RISE
Intervention Description
manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
Intervention Type
Behavioral
Intervention Name(s)
Standard prevention Education
Intervention Description
standard psychosocial Education for HIV/hepatitis prevention
Primary Outcome Measure Information:
Title
AIDS risk behavior based on the Risk Behavior Assessment
Time Frame
assessed monthly during 2 months of study or length of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

HIV Counseling Intervention for Methadone-Maintained Patients - 2

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