HIV Counseling Intervention for Methadone-Maintained Patients - 2

Opioid-Related Disorders Clinical Trial

Official title:

HIV Counseling Intervention for Methadone-Maintained Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061100
• Other study ID #: #3884
• Secondary ID: R01DA0114443884
• Status: Completed
• Phase: Phase 1
• Start date: October 1999
• Est. completion date: October 2003

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Research Foundation for Mental Hygiene, Inc.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AIDS risk behavior based on the Risk Behavior Assessment		assessed monthly during 2 months of study or length of participation