NCT01401270

Brief Summary

The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31% probability of winning and has 3 prize categories, (d) a contingency management condition that arranges a 100% probability of winning and has 7 prize categories, (e) a contingency management condition that arranges a 31% probability of winning and has 7 prize categories, or (f) usual prize contingency management with a 50% probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical across conditions, but lower overall probability conditions arrange for greater chances of winning larger magnitude prizes. The investigators expect that the new contingency management conditions will reduce cocaine use relative to the control condition, that 31% probability conditions will decrease drug use relative to 100% conditions, and that 7-prize category conditions will reduce drug use compared to 3-prize category conditions. In addition, the 31%/7-category condition is expected to be most efficacious. Results will be instrumental for further developing prize contingency management to improve outcomes of cocaine-dependent methadone patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

6.5 years

First QC Date

July 22, 2011

Last Update Submit

March 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • longest continuous period of cocaine abstinence

    three months

Study Arms (6)

Treatment Group A

NO INTERVENTION

Standard Care

Treatment Group B

EXPERIMENTAL

100% probability of winning a prize with each draw and has 3 prize categories

Behavioral: prize contingency management

Treatment Group C

EXPERIMENTAL

31% probability of winning and has 3 prize categories

Behavioral: prize contingency management

Treatment Group D

EXPERIMENTAL

100% probability of winning and has 7 prize categories

Behavioral: prize contingency management

Treatment Group E

EXPERIMENTAL

31% probability of winning and has 7 prize categories

Behavioral: prize contingency management

Treatment Group F

EXPERIMENTAL

usual prize contingency management with a 50% probability of winning from 3 prize categories

Behavioral: prize contingency management

Interventions

Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.

Treatment Group BTreatment Group CTreatment Group DTreatment Group ETreatment Group F

Eligibility Criteria

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

You may qualify if:

  • age \> 18 years
  • current DSM-IV diagnosis of cocaine dependence
  • enrolled at the clinic for \>3 months
  • on a stable dose of methadone (no changes) for \>1 month and not requesting a dose alteration
  • submitted \>1 clinic cocaine positive sample in the last 6 months
  • English speaking
  • pass a quiz related to understanding the informed consent form

You may not qualify if:

  • serious, uncontrolled psychiatric illness
  • significant cognitive impairment
  • in recovery from pathological gambling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sheila M Alessi, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

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

July 22, 2011

First Posted

July 25, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations