NCT02143063

Brief Summary

Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care, standard care plus traditional twice weekly reinforcement, or standard care plus adaptive variable interval reinforcement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

February 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 30, 2021

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

6.2 years

First QC Date

February 24, 2014

Results QC Date

October 31, 2021

Last Update Submit

January 3, 2022

Conditions

Cocaine Use DisorderContingency Management

Outcome Measures

Primary Outcomes (1)

  • Longest Duration of Abstinence From Cocaine

    Longest duration of consecutive cocaine-negative urine toxicology tests

    baseline through 6 months

Secondary Outcomes (1)

  • Longest Duration of Abstinence From All Substances Tested

    baseline through 6 months

Study Arms (3)

standard care

ACTIVE COMPARATOR

standard care

Behavioral: standard care

standard care plus traditional contingency managment

ACTIVE COMPARATOR

prize contingency management on a traditional twice weekly schedule for cocaine abstinence

Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinenceBehavioral: standard care

standard care plus variable interval contingency management

EXPERIMENTAL

prize contingency management on a variable interval schedule for cocaine abstinence

Behavioral: prize contingency management on a variable interval schedule for cocaine abstinenceBehavioral: standard care

Interventions

prize contingency management on a traditional twice weekly schedule for cocaine abstinenceBEHAVIORAL
standard care plus traditional contingency managment
prize contingency management on a variable interval schedule for cocaine abstinenceBEHAVIORAL
standard care plus variable interval contingency management
standard careBEHAVIORAL
standard carestandard care plus traditional contingency managmentstandard care plus variable interval contingency management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be age 18 years or older
  • have a cocaine use disorder diagnosis
  • be willing to sign informed consent and able to pass an informed consent quiz

You may not qualify if:

  • serious, uncontrolled psychiatric illness
  • in recovery from pathological gambling
  • do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Regional Network of Programs, Inc.

Bridgeport, Connecticut, 06610, United States

Location

Alcohol and Drug Recovery Centers, Inc.

Hartford, Connecticut, 06112, United States

Location

The Hospital of Central Connecticut at New Britain General

New Britain, Connecticut, 06050, United States

Location

Behavioral Health Network, Inc.

Springfield, Massachusetts, 01104, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

Analyses presented assessed outcomes at the group-level and using main a priori analytic methods. Additional analyses should assess outcomes in the context of potential baseline predictors, assess for patterns in individual-level trajectories over time and by group, and incorporate additional advanced analytic techniques.

Results Point of Contact

Title
Sheila Alessi, PhD
Organization
UConn Health
salessi@uchc.edu
860-679-1849

Study Officials

  • Nancy Petry, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2014

First Posted

May 20, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 13, 2022

Results First Posted

November 30, 2021

Record last verified: 2022-01

Locations

US(4)