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Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2

Primary Purpose

Opioid-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Opioid-Related Disorders

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Please contact site for information.

Sites / Locations

  • APT Residential Services Division

Outcomes

Primary Outcome Measures

Depression
Withdrawal symptoms
Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior
Opiate withdrawal symptoms

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
July 3, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000319
Brief Title
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2
Official Title
Buprenorphine Maintenance Dose Schedule and Treatment Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of treating opioid-dependent individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders
Keywords
Opioid-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Depression
Title
Withdrawal symptoms
Title
Opioid and cocaine use
Title
Social and psychological functioning
Title
AIDS risk behavior
Title
Opiate withdrawal symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Schottenfeld, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Residential Services Division
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2

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