NCT00555425

Brief Summary

The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 24, 2017

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

4.8 years

First QC Date

November 6, 2007

Results QC Date

January 25, 2016

Last Update Submit

January 10, 2019

Conditions

Opiate Dependence

Keywords

BuprenorphineBuprenorphine/naloxoneCounselingPrimary care

Outcome Measures

Primary Outcomes (1)

  • Illicit Opioid Use

    Urinalysis based on scheduled weekly urine screenings during treatment period

    18 weeks

Secondary Outcomes (6)

  • Proportion of Patients Protectively Transferred

    18 weeks

  • Retention in Treatment

    18 weeks

  • Reduction in Cocaine Use

    18 weeks

  • Changes in HIV Risk

    Baseline and 18 weeks

  • Patient Satisfaction

    18 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.

Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)

2

EXPERIMENTAL

Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.

Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)

Interventions

Behavioral: Buprenorphine/naloxone maintenance (Mtn)BEHAVIORAL

Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.

1
Behavioral: Buprenorphine/naloxone detoxification (Dtx)BEHAVIORAL

Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opioid dependence

You may not qualify if:

  • current dependence on alcohol, cocaine, benzodiazepines or sedatives
  • current suicide or homicide risk
  • current psychotic disorder or untreated major depression
  • inability to read or understand English
  • life-threatening or unstable medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The APT Foundation, Inc. -- Welch Building

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Fiellin DA, Schottenfeld RS, Cutter CJ, Moore BA, Barry DT, O'Connor PG. Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial. JAMA Intern Med. 2014 Dec;174(12):1947-54. doi: 10.1001/jamainternmed.2014.5302.

    PMID: 25330017DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. David Fiellin
Organization
Yale University
david.fiellin@yale.edu
203-688-2471

Study Officials

  • David A. Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 8, 2007

Study Start

July 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 14, 2019

Results First Posted

January 24, 2017

Record last verified: 2019-01

Locations

US(2)