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Contingency Management for Persons With Severe Mental Illness

Primary Purpose

Substance Abuse

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

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

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

Inclusion Criteria:

  • age 18 years or older
  • meet DSM-IV criteria for cocaine abuse or dependence
  • English speaking
  • pass a brief quiz regarding study procedures to ensure understanding of the informed consent process.

Exclusion Criteria:

  • dementia
  • in recovery from pathological gambling

Sites / Locations

  • Community Mental Health Affiliates, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard Care

Contingency management for abstinence from drugs

Arm Description

Outcomes

Primary Outcome Measures

longest continuous period of cocaine abstinence

Secondary Outcome Measures

other drug use and psychosocial problems

Full Information

First Posted
November 21, 2011
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
NCT01478815
Brief Title
Contingency Management for Persons With Severe Mental Illness
Official Title
Contingency Management for Persons With Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (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
Yes

5. Study Description

Brief Summary
Contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems. This pilot project will estimate effect sizes of contingency management for reducing cocaine use in patients receiving psychiatric care at a large community based mental health program. In total, 30 cocaine abusing patients will be randomized to one of two 8-week treatment conditions: standard care or standard care with contingency management. Patients in both conditions will provide breath and urine samples for toxicology testing twice per week. In the contingency management condition, patients will receive the opportunity to win prizes for submitting cocaine negative urine samples. The investigators expect that patients receiving contingency management will evidence reductions in cocaine use and may show improvements in psychiatric symptoms and psychosocial functioning relative to patients in standard care. Effect size estimates obtained from this study will be used to guide larger scale and longer duration evaluations of contingency management for dually diagnosed patients.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Title
Contingency management for abstinence from drugs
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
contingency management
Intervention Description
Participants will receive the opportunity to win prizes for submitting cocaine negative urine samples.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard Care
Primary Outcome Measure Information:
Title
longest continuous period of cocaine abstinence
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
other drug use and psychosocial problems
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years or older meet DSM-IV criteria for cocaine abuse or dependence English speaking pass a brief quiz regarding study procedures to ensure understanding of the informed consent process. Exclusion Criteria: dementia in recovery from pathological gambling
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
Community Mental Health Affiliates, Inc.
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06051
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23182410
Citation
Petry NM, Alessi SM, Rash CJ. A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. Drug Alcohol Depend. 2013 Jun 1;130(1-3):234-7. doi: 10.1016/j.drugalcdep.2012.10.017. Epub 2012 Nov 20.
Results Reference
derived

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Contingency Management for Persons With Severe Mental Illness

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