search
Back to results

Enhanced and Attendance-based Prize CM in Community Settings

Primary Purpose

Cocaine Dependence

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 Cocaine Dependence 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 dependence
  • A cocaine-positive urine sample submitted during the first two scheduled treatment days at the center
  • Willing to provide names, addresses and phone numbers of individuals to assist in locating the patient for follow-up evaluations
  • English speaking
  • Willing to sign informed consent.

Exclusion Criteria:

  • Serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
  • Dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)
  • In recovery from pathological gambling

Sites / Locations

  • UConn Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

4

Arm Description

Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.

Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $560 in prizes and twice-weekly breath and urine samples.

Standard Treatment plus prize contingency management for attendance with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.

Standard Treatment

Outcomes

Primary Outcome Measures

longest continuous period of cocaine abstinence

Secondary Outcome Measures

Full Information

First Posted
January 22, 2008
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00606853
Brief Title
Enhanced and Attendance-based Prize CM in Community Settings
Official Title
Enhanced and Attendance-based Prize CM in Community Settings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (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 address the conditions under which prize contingency management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent patients. For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM procedures will be provided as additions to standard care and will reinforce drug abstinence but will differ in expected magnitudes of prizes patients can earn, especially during early stages of abstinence. They will provide expected magnitudes of winning about $250 and $560, respectively. We expect that both CM conditions will improve retention and abstinence relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders better outcomes than the $250 CM condition, this finding would suggest that patients initiating treatment while actively using cocaine may best be treated with relatively high reinforcement prize CM as an adjunct to standard care. For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude of winnings will be about $250, and again CM treatment will be in addition to standard care. This CM condition will be compared to standard treatment without CM as well as to a CM treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence. Results from this study will inform an important clinical question of whether simply reinforcing attendance can improve clinical outcomes. Increased retention may result in greater exposure to therapeutic processes that may reduce drug use, especially among patients who begin treatment having already achieved some abstinence. We will also evaluate the cost-effectiveness of CM by examining the effects of the interventions on hospitalizations, medical and psychiatric care, criminal justice costs, and productivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
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
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.
Arm Title
2
Arm Type
Experimental
Arm Description
Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $560 in prizes and twice-weekly breath and urine samples.
Arm Title
3
Arm Type
Experimental
Arm Description
Standard Treatment plus prize contingency management for attendance with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.
Arm Title
4
Arm Type
No Intervention
Arm Description
Standard Treatment
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Rewards valued $1-$100 for abstinence or treatment attendance
Primary Outcome Measure Information:
Title
longest continuous period of cocaine abstinence
Time Frame
baseline and at each follow-up

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 dependence A cocaine-positive urine sample submitted during the first two scheduled treatment days at the center Willing to provide names, addresses and phone numbers of individuals to assist in locating the patient for follow-up evaluations English speaking Willing to sign informed consent. Exclusion Criteria: Serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) Dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975) In recovery from pathological gambling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
UConn Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhanced and Attendance-based Prize CM in Community Settings

We'll reach out to this number within 24 hrs