Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 15, 2008 | ||||
| Last Updated Date | March 28, 2012 | ||||
| Start Date ICMJE | April 2008 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Stimulant drug use as measured by urine analysis [ Time Frame: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00809770 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| 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 of Psychostimulant Abuse in the Severely Mentally Ill | ||||
| Official Title ICMJE | Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill | ||||
| Brief Summary | The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness. |
||||
| Detailed Description | This study will evaluate the efficacy of a twelve week contingency management (CM) intervention for treating psycho-stimulant substance abuse when delivered in the context of a community mental health center (CMHC) setting for adults suffering from serious mental illness (SMI). The CM paradigm to be used is one which has been shown effective in several recent large clinical trials, using the variable magnitude of reinforcement procedure. The reinforcers will be vouchers or actual items useful for day to day living in this population. Two hundred SMI participants with co-occurring stimulant disorders will be recruited from a large urban CMHC and randomized to receive either the active CM paradigm plus treatment as usual (TAU), or TAU which will include the delivery of reinforcement for study involvement (reinforcement that is not contingent on drug abstinence). The primary outcome is change in psycho-stimulant use (methamphetamine, amphetamine and/or cocaine). Secondary outcomes include: changes in use of other illegal drugs or alcohol; changes in CMHC treatment adherence and follow-through; changes in psychiatric symptoms, quality of life, and community outcomes (homelessness, incarcerations, etc.). Additional outcomes to be measured include changes in drug craving, stage of change, nicotine use, and HIV risk status. The study involves two phases, the 12 week treatment phase, where CM and control treatments are delivered, as well as a 3 month follow up phase. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | McDonell MG, Srebnik D, Angelo F, McPherson S, Lowe JM, Sugar A, Short RA, Roll JM, Ries RK. Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness. Am J Psychiatry. 2013 Jan 1;170(1):94-101. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| 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 | NCT00809770 | ||||
| Other Study ID Numbers ICMJE | RDA022476A, R01DA022476, R01 DA022476-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Richard Ries, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Washington | ||||
| Verification Date | March 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||