Combining Behavioral Treatment With Agonist Maintenance - 1 | NCT00000311

Studies
Combining Behavioral Treatment With Agonist Maintenance - 1

NCT00000311

Sponsor

Yale University

Status

Completed

Last Update Posted

Jan 17, 2018Actual

Enrollment

168Actual

Phase

Phase 3

Conditions

Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders

Interventions

Buprenorphine
methadone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA009413	U.S. NIH Grant/Contract		View source
R01-09413-1

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1995

Primary Completion Date

Feb 1999Actual

Completion Date

Feb 1999Actual

First Submitted Date

Sep 20, 1999

First Submission Date that Met QC Criteria

Sep 20, 1999

First Posted Date

Sep 21, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2018

Last Update Posted Date

Jan 17, 2018Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine	Drug	Medication and Behavioral	3 4
methadone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression		24 weeks
Withdrawal symptoms
Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Please contact site for information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Schottenfeld, M.D.	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
APT Residential Services Division		New Haven	Connecticut	06519	United States

Condition Browse Module

MeSH Terms

ID	Term
D019970	Cocaine-Related Disorders
D009293	Opioid-Related Disorders
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D000079524	Narcotic-Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002047	Buprenorphine
D008691	Methadone

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided