NCT04927143 Encouraging Abstinence Behavior in a Drug Epidemic: Optimizing Dynamic Incentives
| NCT ID | NCT04927143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-09-15 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2021-09-15 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Combatting the rise of the opioid epidemic is a central challenge of U.S. health care policy. A promising approach for improving welfare and decreasing medical costs of people with substance abuse disorders is offering incentive payments for healthy behaviors. This approach, broadly known as "contingency management" in the medical literature, has repeatedly shown to be effective in treating substance abuse. However, the use of incentives by treatment facilities remains extremely low. Furthermore, it is not well understood how to design optimal incentives to treat opioid abuse. This project will conduct a randomized evaluation of two types of dynamically adjusting incentive schedules for people with opioid use disorders or cocaine use disorders: "escalating" schedules where incentive amounts increase with success to increase incentive power, and "de-escalating" schedules where incentive amounts decrease with success to improve incentive targeting. Both schemes are implemented with a novel "turnkey" mobile application, making them uniquely low-cost, low-hassle, and scalable. Effects will be measured on abstinence outcomes, including longest duration of abstinence and the percentage of negative drug tests. In combination with survey data, variation from the experiment will shed light on the barriers to abstinence more broadly and inform the understanding of optimal incentive design.
Eligibility Criteria
Inclusion Criteria: * Age at least 18 years old; * Meet DSM-5 OUD, CoUD, or MUD criteria as evidenced by an OUD CPT code F11\* (opioid related disorders), a CoUD CPT code F14\* (cocaine related disorders), a MUD CPT code F15.1/F15.2 or other clinical notes indicating illicit opioid/cocaine/methamphetamine use for treatment * Have access to a smartphone (iOS or Android) with data plan and willing to download DynamiCare app; * Have an email and can access it from their smartphone; * Are in residential, day (PHP), partial day (IOP), or outpatient (OP) AODA treatment; * Are likely to be helped by contingency management because at least ONE of the following conditions is true: 1. Were first enrolled in residential, PHP, or IOP substance use treatment no longer than 2 treatment weeks (14 days/encounters of treatment) prior to providing informed consent. 2. Used non-medical opioids, cocaine, and/or methamphetamine within the last 21 days. * Understands English. Exclusion Criteria: * Have evidence of active (non-substance related) psychosis that might impair participation as determined by the PI. * 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.
Contact & Investigator
Mercedes Robaina, PhD
PRINCIPAL INVESTIGATOR
Advocate Aurora Behavioral Health Services
Frequently Asked Questions
Who can join the NCT04927143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04927143 currently recruiting?
Yes, NCT04927143 is actively recruiting participants. Contact the research team at kevin.petranu@aah.org for enrollment information.
Where is the NCT04927143 trial being conducted?
This trial is being conducted at Oconomowoc, United States, Wauwatosa, United States.
Who is sponsoring the NCT04927143 clinical trial?
NCT04927143 is sponsored by Wake Forest University Health Sciences. The principal investigator is Mercedes Robaina, PhD at Advocate Aurora Behavioral Health Services. The trial plans to enroll 600 participants.