Expired Study
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New York, New York 10032


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

Study summary:

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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

HIV Counseling Intervention for Methadone-Maintained Patients - 2

Official Title:

HIV Counseling Intervention for Methadone-Maintained Patients

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:

60 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Frances R Levin, M.D.
Principal Investigator
Research Foundation for Mental Hygiene, Inc.

Study Dates

Start Date:October 1999
Completion Date:October 2003
Completion Type:Actual
Primary Completion Date:October 2003
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 22, 2019
First Received Date:May 21, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:AIDS risk behavior based on the Risk Behavior Assessment
Time Frame:assessed monthly during 2 months of study or length of participation
Safety Issues:False

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:RISE intervention
Description:Targeted RISE intervention- Behavior therapy Rise
Study Arm Type:Active Comparator
Arm Name:Standard Education
Description:Education intervention. Standard prevention education

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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