HIV Counseling Intervention for Methadone-Maintained Patients - 2

NCT ID: NCT00061100

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2003-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RISE intervention

Targeted RISE intervention- Behavior therapy Rise

Group Type EXPERIMENTAL

Behavior Therapy-RISE

Intervention Type BEHAVIORAL

manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter

Standard Education

Education intervention. Standard prevention education

Group Type ACTIVE_COMPARATOR

Standard prevention Education

Intervention Type BEHAVIORAL

standard psychosocial Education for HIV/hepatitis prevention

Interventions

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Behavior Therapy-RISE

manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter

Intervention Type BEHAVIORAL

Standard prevention Education

standard psychosocial Education for HIV/hepatitis prevention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Frances R Levin

Director of Substance Use Disorder

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frances R Levin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Research Foundation for Mental Hygiene, Inc.

Locations

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Research Foundation for Mental Hygiene, Inc.

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA011444

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3884

Identifier Type: OTHER

Identifier Source: secondary_id

#3884

Identifier Type: -

Identifier Source: org_study_id

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