A SMART Design for Attendance-based Prize CM

April 5, 2019 updated by: UConn Health
The purpose of this study is to compare different forms of treatment for substance abuse. This study will involve a type of treatment called contingency management, in which patients receive incentives (prizes) for attending outpatient treatment. This study will compare contingency management to standard treatment that does not involve incentives. This study will also compare contingency management treatment that lasts 6 weeks to contingency management that lasts 12 weeks. Finally, this study will compare contingency management treatment delivered at the beginning of outpatient treatment to contingency management treatment delivered later during outpatient treatment. The investigators hypothesize that (1) a 12-week attendance-based contingency management intervention will improve retention and enhance drug abstinence versus standard treatment, (2) initial short-term exposure to attendance-based contingency management (in weeks 1-6 only) will improve substance abuse treatment outcomes compared to standard treatment alone, and (3) contingency management in weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug use during initial stages of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 18 years
  • current DSM-IV diagnosis of cocaine abuse or dependence or recent cocaine use (self-reported use in past 30 days or positive urine toxicology screen)
  • willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

  • serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
  • in recovery from pathological gambling (meet DSM-IV criteria for lifetime pathological gambling and are actively trying to refrain from gambling)
  • do not speak English (all treatment is provided in English at these clinics)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment Group A
Individuals randomized to Treatment Group A will receive standard treatment for study weeks 1-6.
Experimental: Treatment Group B
Individuals randomized to Treatment Group B will receive contingency management plus standard treatment for study weeks 1-6.
Behavioral: contingency management
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.
No Intervention: Aftercare Group A
All participants will be re-randomized after study week 6. Those participants assigned to Aftercare Group A will receive standard treatment for study weeks 7-12.
Experimental: Aftercare Group B
All participants will be re-randomized after study week 6. Those participants assigned to Aftercare Group B will receive contingency management treatment plus standard treatment for weeks 7-12.
Behavioral: contingency management
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
longest duration of negative drug and alcohol samples submitted
Time Frame: throughout active phase and at each follow-up assessment
throughout active phase and at each follow-up assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
proportions of samples testing negative for drugs and alcohol
Time Frame: during active phase and at each follow-up assessment
during active phase and at each follow-up assessment
psychosocial functioning and HIV risk behaviors
Time Frame: baseline, active phase and at each follow-up assessment
baseline, active phase and at each follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Nancy M Petry, Ph.D., UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 7, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-053-2
  • P50DA009241-16 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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