NCT00914381

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 1994

Longer than P75 for phase_2

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

Study Start

First participant enrolled

December 1, 1994

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
Last Updated

March 31, 2020

Status Verified

June 1, 2009

Enrollment Period

7.3 years

First QC Date

June 3, 2009

Last Update Submit

March 27, 2020

Conditions

Cocaine Dependence

Keywords

Community reinforcement approachContingency management12-step facilitation counselingCocaine dependenceWomen

Outcome Measures

Primary Outcomes (1)

  • Cocaine abstinence

    24 weeks

Secondary Outcomes (1)

  • Reduced HIV risk behavior

    24 weeks

Study Arms (4)

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

Behavioral therapyBEHAVIORAL
CRA + CMCRA + VCTSF + CMTSF + VC

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The APT Foundation, Inc. MRU

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Richard S. Schottenfeld, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 5, 2009

Study Start

December 1, 1994

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

March 31, 2020

Record last verified: 2009-06

Locations

US(2)