Behavioral Treatment for Cocaine Dependent Women | NCT00914381

Studies
Behavioral Treatment for Cocaine Dependent Women

NCT00914381

Sponsor

Yale University

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

145Actual

Phase

Phase 2

Conditions

Cocaine Dependence

Interventions

Behavioral therapy

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
R01DA006915	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2009

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

Dec 1994

Primary Completion Date

Mar 2002Actual

Completion Date

Mar 2002Actual

First Submitted Date

Jun 3, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 5, 2009Estimated

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

Mar 27, 2020

Last Update Posted Date

Mar 31, 2020Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.

Detailed Description

Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRA + CM	Active Comparator	Community Reinforcement Approach (CRA) combined with Contingency Management (CM)	Behavioral: Behavioral therapy
TSF + CM	Active Comparator	Twelve-Step Facilitation (TSF) combined with Contingency Management (CM)	Behavioral: Behavioral therapy
CRA + VC	Active Comparator	Community Reinforcement Approach (CRA) combined with Voucher Control (VC)	Behavioral: Behavioral therapy
TSF + VC	Active Comparator	Twelve-Step Facilitation (TSF) combined with Voucher Control (VC)	Behavioral: Behavioral therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioral therapy	Behavioral		CRA + CM CRA + VC TSF + CM TSF + VC

Measure	Description	Time Frame
Cocaine abstinence		24 weeks

Measure	Description	Time Frame
Reduced HIV risk behavior		24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women meeting DSM IV criteria for cocaine dependence
Women meeting DSM IV criteria for cocaine dependence with custody of a young child

Exclusion Criteria:

Opioid dependence
Psychosis
Severe depression
Current treatment with any anti-depressant or anti-psychotic medication
Medical instability
Inability to understand or read English

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The APT Foundation, Inc. MRU		New Haven	Connecticut	06519	United States
Yale University School of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D019970	Cocaine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001521	Behavior Therapy

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided