NCT00000311

Brief Summary

The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 1995

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1995

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1999

Completed
8 months 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

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4 years

First QC Date

September 20, 1999

Last Update Submit

January 12, 2018

Conditions

Cocaine-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

Keywords

Cocaine-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

Outcome Measures

Primary Outcomes (5)

  • Depression

    24 weeks

  • Withdrawal symptoms

  • Opioid and cocaine use

  • Social and psychological functioning

  • AIDS risk behavior

Study Arms (4)

1

EXPERIMENTAL

Methadone + CM (contingency management)

Drug: methadone

2

EXPERIMENTAL

methadone + VC (voucher control)

Drug: methadone

3

EXPERIMENTAL

Buprenorphine + CM

Drug: Buprenorphine

4

EXPERIMENTAL

Buprenorphine + VC

Drug: Buprenorphine

Interventions

BuprenorphineDRUG

Medication and Behavioral

34
methadoneDRUG

medication and behavioral

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Please contact site for information.

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Sponsors & Collaborators

Study Sites (1)

APT Residential Services Division

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

Interventions

BuprenorphineMethadone

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Richard Schottenfeld, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

February 1, 1995

Primary Completion

February 1, 1999

Study Completion

February 1, 1999

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

US(1)