Contingency Management for Persons With Severe Mental Illness
| Tracking Information | |||||
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| First Received Date ICMJE | November 21, 2011 | ||||
| Last Updated Date | January 15, 2013 | ||||
| Start Date ICMJE | December 2011 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
longest continuous period of cocaine abstinence [ Time Frame: Week 8 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01478815 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
other drug use and psychosocial problems [ Time Frame: Week 8 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Contingency Management for Persons With Severe Mental Illness | ||||
| Official Title ICMJE | Contingency Management for Persons With Severe Mental Illness | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Substance Abuse | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 19 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01478815 | ||||
| Other Study ID Numbers ICMJE | 12-070-3, P30DA023918 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Connecticut Health Center | ||||
| Study Sponsor ICMJE | University of Connecticut Health Center | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Connecticut Health Center | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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