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A SMART Design for Attendance-based Prize CM

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
contingency management
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance Abuse, Contingency Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Treatment Group A

Treatment Group B

Aftercare Group A

Aftercare Group B

Arm Description

Individuals randomized to Treatment Group A will receive standard treatment for study weeks 1-6.

Individuals randomized to Treatment Group B will receive contingency management plus standard treatment for study weeks 1-6.

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.

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.

Outcomes

Primary Outcome Measures

longest duration of negative drug and alcohol samples submitted

Secondary Outcome Measures

proportions of samples testing negative for drugs and alcohol
psychosocial functioning and HIV risk behaviors

Full Information

First Posted
February 7, 2009
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00840151
Brief Title
A SMART Design for Attendance-based Prize CM
Official Title
A SMART Design for Attendance-based Prize CM
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance Abuse, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A
Arm Type
No Intervention
Arm Description
Individuals randomized to Treatment Group A will receive standard treatment for study weeks 1-6.
Arm Title
Treatment Group B
Arm Type
Experimental
Arm Description
Individuals randomized to Treatment Group B will receive contingency management plus standard treatment for study weeks 1-6.
Arm Title
Aftercare Group A
Arm Type
No Intervention
Arm Description
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.
Arm Title
Aftercare Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
contingency management
Intervention Description
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.
Primary Outcome Measure Information:
Title
longest duration of negative drug and alcohol samples submitted
Time Frame
throughout active phase and at each follow-up assessment
Secondary Outcome Measure Information:
Title
proportions of samples testing negative for drugs and alcohol
Time Frame
during active phase and at each follow-up assessment
Title
psychosocial functioning and HIV risk behaviors
Time Frame
baseline, active phase and at each follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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A SMART Design for Attendance-based Prize CM

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