Substance-Related Disorders Clinical Trial
Official title:
Encouraging Opioid Abstinence Behavior: Incentivizing Inputs and Outcomes - Pilot
NCT number | NCT04235582 |
Other study ID # | 19-1095 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 25, 2020 |
Est. completion date | May 15, 2021 |
Verified date | January 2021 |
Source | Aurora Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to address two key questions in the literature on incentives for substance use. The first question is whether it is more effective to directly incentivize the outcome of interest - drug abstinence - or to incentivize behaviors that are inputs into the production of abstinence. This study will compare two versions of the incentive program: one that incentivizes inputs to achieving abstinence and one that incentivizes the outcome of abstinence. The second question is how to optimize the size of incentives over time to maximize incentive effectiveness. This will be done by randomly varying the size and timing of incentives offered to participants in both the Inputs and Outcomes groups. The incentive amounts will then be varied across participants and time to fit a structural model of abstinence behaviors over time. The model will be used to describe the optimal shape of incentives over time.
Status | Completed |
Enrollment | 36 |
Est. completion date | May 15, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion 1. Age at least 18 years old; 2. Meet DSM-5 opioid use disorder criteria as evidenced by an opioid disorder CPT code F11 (opioid related disorders); 3. Have access to a smartphone (iOS or Android) with data plan and willing to download DynamiCare app; 4. Are in day (PHP) or partial day (IOP) AODA treatment in Aurora Health's Behavioral Health Program; 5. Are currently prescribed or will be prescribed within 1-4 days oral buprenorphine for their OUD; 6. Are likely to be helped by contingency management because at least ONE of the following conditions is true: 1. Were first enrolled in day or partial day opioid treatment no longer than 1 week prior to providing informed consent. 2. Currently using non-medical opioids. 3. Regularly missing scheduled AODA appointments. 7. Understands English. Exclusion Criteria: 1. Have evidence of active (non-substance related) psychosis that might impair participation as determined by the PI. 2. Has significant cognitive impairment that might confound participation as determined by the PI or are so significantly cognitively impaired that they have a legal guardian. Note that pregnant women are not excluded from participating in the study |
Country | Name | City | State |
---|---|---|---|
United States | University of California - Santa Cruz | Berkeley | California |
United States | University of Chicago | Chicago | Illinois |
United States | Aurora Psychiatric Hospital | Wauwatosa | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Aurora Health Care | University of California, Berkeley, University of Chicago |
United States,
Benishek LA, Dugosh KL, Kirby KC, Matejkowski J, Clements NT, Seymour BL, Festinger DS. Prize-based contingency management for the treatment of substance abusers: a meta-analysis. Addiction. 2014 Sep;109(9):1426-36. doi: 10.1111/add.12589. Epub 2014 May 23. — View Citation
Kurti AN, Davis DR, Redner R, Jarvis BP, Zvorsky I, Keith DR, Bolivar HA, White TJ, Rippberger P, Markesich C, Atwood G, Higgins ST. A Review of the Literature on Remote Monitoring Technology in Incentive-Based Interventions for Health-Related Behavior Change. Transl Issues Psychol Sci. 2016 Jun;2(2):128-152. — View Citation
Lussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 2006 Feb;101(2):192-203. Review. — View Citation
Petry NM, Alessi SM, Carroll KM, Hanson T, MacKinnon S, Rounsaville B, Sierra S. Contingency management treatments: Reinforcing abstinence versus adherence with goal-related activities. J Consult Clin Psychol. 2006 Jun;74(3):592-601. — View Citation
Schottenfeld RS, Chawarski MC, Pakes JR, Pantalon MV, Carroll KM, Kosten TR. Methadone versus buprenorphine with contingency management or performance feedback for cocaine and opioid dependence. Am J Psychiatry. 2005 Feb;162(2):340-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Continuous Abstinence From Opioid Use | The primary endpoint is the longest period of continuous abstinence from illicit opioids, where abstinence is measured using lab-verified in-person urine-tests, saliva tests, or subject reporting (in the absence of urine testing). | Time = 4 weeks | |
Primary | Continuous Abstinence From Opioid Use | The primary endpoint is the longest period of continuous abstinence from illicit opioids, where abstinence is measured using lab-verified in-person urine-tests, saliva tests, or subject reporting (in the absence of urine testing). | Time = 8 weeks | |
Primary | Opioid-negative Saliva Tests at Week 12 | The primary endpoint is the % of opioid-negative saliva or urine tests in each group at Week 12 | Time = 12 weeks |
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