Automated Prize-based Contingency Management to Increase Counseling Attendance in Opiate-Replacement-Therapy Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 26, 2010 | ||||
| Last Updated Date | June 28, 2012 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Participant Feedback; Counselor Feedback; XPMI Performance | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01229163 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Automated Prize-based Contingency Management to Increase Counseling Attendance in Opiate-Replacement-Therapy Patients | ||||
| Official Title ICMJE | Automated Prize-Based Contigency Management to Increase Counseling Attendance in Opiate-Replacement-Therapy Patients | ||||
| Brief Summary | Background: - Treatment outcomes for substance abuse are improved by regular attendance at counseling sessions, and attending at counseling sessions can be futher improved by prize-based incentives. However, a system of prize-based incentives can be difficult to administer without computerization for accurate recordkeeping and rapid calculation of earnings. NIDA researchers have developed the eXtensible Platform for Motivational Incentives (XPMI), a computer program that for reinforcement of weekly counseling attendance. Users are eligible to win prizes through automated draws. The researchers are interested in testing the effectiveness and ease of use of the XPMI software so it can ultimately be run by staff in community treatment programs. Objectives:
Eligibility: - Individuals at least 18 years of age who are participating in clinical trials for treatment of heroin dependence in an outpatient treatment-research program, and have at least 14 weeks remaining in the program. Design:
|
||||
| Detailed Description | Background. Community implementation is a barrier to technology transfer of contingency management (CM), an effective behavioral treatment for substance dependence. The Biomedical Informatics Section (BIS), the Treatment Section, and the NIDA Blending team are developing and validating software for automated contingency management (ACM) for free distribution and use in community treatment programs. This is part of a collaborative effort between NIDA and SAMHSA to facilitate use of CM in the community. Scientific goals. To validate the usability and robustness of our ACM program, eXtensible Platform for Motivational Incentives (XPMI), implemented under conditions simulating those of a community treatment program with minimal technology support. Participant population. Up to 30 outpatients (20 completers) participating in treatment studies at Archway clinic. Target enrollment for the outpatients will include 30% women and 60% minorities (mostly African-American). Experimental design and methods. In this field test, Archway counseling staff will use XPMI to reinforce participants' attendance at up to 12 counseling sessions for up to 14 weeks. (Participants who are still enrolled in the clinic at the end of this period will be considered completers.) Participants will earn opportunities to draw for prizes each time they attend their weekly counseling session on time and as scheduled. A record of any problems in using the program and the possible recommended solutions will be maintained. Feedback on problems, accuracy, and simplicity will be given to the software-development team at BIS on an ongoing basis. BIS will fix any problems as they arise. Benefits to participants and/or society. There are no direct benefits to the participants. Availability of XPMI may improve technology transfer of a proven effective treatment to the community. Risks to participants. Risks of participation are minimal. This is a secondary study; participants' decisions about enrollment and compliance will not affect their status in their primary studies. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
||||
| Condition ICMJE | Opiate-Replacement Therapy | ||||
| Intervention ICMJE | Device: Automated Contingency Management (ACM) software
N/A |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* 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 | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Enrollment in a substance abuse treatment protocol in Archway, with attendance having started at least 4 weeks prior to admission into this protocol (to allow time for stabilization in treatment). EXCLUSION CRITERIA: Less than 14 weeks remaining in primary protocol. |
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01229163 | ||||
| Other Study ID Numbers ICMJE | 999911464, 11-DA-N464 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | April 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||