NCT00000205

Brief Summary

The purpose of this study is to compare the efficacy of buprenorphine versus methadone.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1990

Typical duration for phase_3

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

October 1, 1990

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1993

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1993

Completed
6.1 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
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.4 years

First QC Date

September 20, 1999

Last Update Submit

July 7, 2016

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (4)

  • Retention

  • Opiate use

  • Opiate craving

  • Adverse events

Interventions

BuprenorphineDRUG

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

You may not qualify if:

  • Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and /or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Los Angeles, California, 90025, United States

Location

Related Publications (3)

  • Ling W, Wesson DR, Charuvastra C, Klett CJ. A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence. Arch Gen Psychiatry. 1996 May;53(5):401-7. doi: 10.1001/archpsyc.1996.01830050035005.

    PMID: 8624183BACKGROUND

  • Compton PA, Ling W, Charuvastra VC, Wesson DR. Buprenorphine as a pharmacotherapy for cocaine abuse: a review of the evidence. J Addict Dis. 1995;14(3):97-114. doi: 10.1300/J069v14n03_07.

    PMID: 8555282BACKGROUND

  • Compton PA, Ling W, Wesson DR, Charuvastra VC, Wilkins J. Urine toxicology as an outcome measure in drug abuse clinical trials: must every sample be analyzed? J Addict Dis. 1996;15(2):85-92. doi: 10.1300/J069v15n02_07.

    PMID: 8704003BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-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

  • Walter Ling, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

October 1, 1990

Primary Completion

March 1, 1993

Study Completion

September 1, 1993

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

US(1)