Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

NCT ID: NCT00622596

Last Updated: 2016-08-24

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

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study was to expand access to buprenorphine using a mobile health care system among marginalized populations with or at high risk for HIV and observe longitudinal effects of treatment.

Detailed Description

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Conditions

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Opiate Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobile Access to Buprenorphine

High risk populations accessing a mobile health care system can obtain Buprenorphine for treatment.

Group Type EXPERIMENTAL

Mobile Access

Intervention Type OTHER

Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.

Interventions

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Mobile Access

Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV +
* At high risk for HIV (IV drug use, commercial sex worker, partner of HIV+)
* Mental Health (unmanaged or diagnosed mental illness)

Exclusion Criteria

* Benzodiazepine use
* Opiate use due to pain management issues only (present or past)
* Non-IDU
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick L Altice, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine/AIDS Program

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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0504027630

Identifier Type: -

Identifier Source: org_study_id

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