HIV Counseling Intervention for Methadone-Maintained Patients - 2

New York State Psychiatric Institute

Status and phase: Completed; Phase 1

Conditions: Opioid-Related Disorders

Treatments: Behavioral: Behavior Therapy-RISE; Behavioral: Standard prevention Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00061100

#3884

3884 (Other Identifier)

R01DA011444 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

RISE intervention

Experimental group

Description:

Targeted RISE intervention- Behavior therapy Rise

Treatment:

Behavioral: Behavior Therapy-RISE

Standard Education

Active Comparator group

Description:

Education intervention. Standard prevention education

Treatment:

Behavioral: Standard prevention Education