NCT00000318

Brief Summary

The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

December 1, 2008

Enrollment Period

9.3 years

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (3)

  • Opioid and cocaine use

    26 weeks

  • Social and psychological functioning

    26 weeks

  • AIDS risk behavior

    26 weeks

Study Arms (2)

1

EXPERIMENTAL

Maintenance treatment with daily medication

Drug: Buprenorphine

2

EXPERIMENTAL

Maintenance treatment with thrice-weekly medication

Drug: Buprenorphine

Interventions

BuprenorphineDRUG

1. Experimental Maintenance treatment with daily medication 2. Experimental Maintenance treatment with thrice-weekly medication

12

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

APT Residential Services Division

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Richard Schottenfeld, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

December 1, 1994

Primary Completion

March 1, 2004

Study Completion

August 1, 2007

Last Updated

January 12, 2017

Record last verified: 2008-12

Locations

US(1)