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Opioid Use DisorderNCT05521854

Contingency Management for Drug Use: Does Age Matter?

A study testing DynamiCare app (app-based contingency management) in people with Opioid Use Disorder and Methamphetamine Abuse, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The OVERALL AIM is to assess whether app-based incentives are effective for older adults and to quantify the associations between age and both the efficacy and take-up of app-based incentives. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DynamiCare app (app-based contingency management)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
2 sitesUnited States
Study dates
1 May 2023to 26 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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.
  • Used non-medical opioids, cocaine, and/or methamphetamine within the last 21 days.
  • Understands English.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Advocate Health Care

    Chicago, Illinois, 60007

  • Aurora Behavioral Health Services

    Milwaukee, Wisconsin, 53213

Other trials in United States

About this study

Official title: Encouraging Abstinence Behavior in a Drug Epidemic: Does Age Matter?

The OVERALL AIM is to assess whether app-based incentives are effective for older adults and to quantify the associations between age and both the efficacy and take-up of app-based incentives. This will allow us to determine if older adults with substance use disorders (SUDs) are willing to engage with app-based incentives and whether they perform similarly to their younger counterparts. Because the study will leverage data from an existing study on app-based incentives, a small add-on study is sufficient to address these three aims. This aim will be achieved while simultaneously gathering data that will shed light on the two aims of the first phase of the study: whether app-based incentives are effective overall, and how to optimize the size of incentives over time to maximize their effectiveness.

Read the detailed description

Phase 1 Numerous studies have tested whether providing incentives to encourage abstinence from drugs can further reduce drug abuse in a drug-treatment setting. The results are promising: Incentives to reduce opioid abuse increase the average duration of abstinence by 25 - 60% relative to medication and counseling alone (Petry et al., 2006; Schottenfeld et al., 2005). Similar effects have been demonstrated repeatedly across a wealth of populations, substance-abuse disorders, and payment methodologies (see Lussier et al., 2006; Higgins et al., 2011; Davis et al., 2016; and Higgins et al., 2016 for reviews of providing incentives for managing addiction).

Despite evidence that incentives are effective and the increasing need for effective approaches to combat the addiction crisis, incentive programs have not been widely implemented. A key barrier is that while the benefits are largely borne by patients and taxpayers, there are large logistical costs that must be borne by clinics: most existing incentive programs involve manual, in-person measurement of behaviors, and prize or voucher purchase and delivery by clinic staff. The significant clinic-level legwork necessary to set up these programs, including setting up behavioral and payment tracking systems, training staff, etc., have prevented the programs from scaling widely (Benishek et al., 2014). In sum, prior experience has consistently shown that incentives increase duration of treatment and decrease substance abuse, but the logistical complications remain a hurdle to implementation.

The investigators propose to conduct the first randomized evaluation of an innovative, scalable incentives program for drug addiction delivered through a mobile application. The application, which was developed by DynamiCare Health (henceforth "DynamiCare"), provides a "turnkey" solution that health clinics can easily prescribe. The app enables remote monitoring of behavior; for example, drug tests can be administered in patients' homes, as patients submit "selfie-videos" showing them taking saliva drug tests, which are then verified by trained remote staff. Treatment adherence can similarly be checked through GPS tracking for on-site methadone pharmacotherapy. The efficacy of this approach has not been tested rigorously before.

This study phase will address two key knowledge gaps in the logistics of existing incentive program design for drug addiction. First, the study will test technology for remote monitoring of abstinence behavior for drug use. Remote monitoring of abstinence from cigarettes and alcohol has been integral in reducing the costs and extending the potential reach of incentive programs for people with nicotine/tobacco and alcohol use disorders (e.g. to vulnerable or rural populations), and the study promises to do the same for illicit drug addiction (see for a review of remote monitoring technologies for incentive delivery). The second gap is in remote delivery of incentives. After a behavior is verified, the app will deliver incentives to patients as cash available on a linked debit card. The delay between monitoring of the target behavior and the delivery of financial incentives has been shown to be a significant moderator of treatment effect size (Lussier, Heil, Mongeon, Badger, \& Higgins, 2006). The technology allows patients to receive incentives almost immediately following the undertaking of the incentivized behavior: a first in incentives for drug addiction.

The second question is how to optimize the size of incentives over time to maximize incentive effectiveness. This will be performed by randomly varying the size and timing of incentives offered to participants across groups. The variation in incentive amounts will vary across participants and time to fit a structural model of abstinence behaviors over time. This model will be used to describe the optimal shape of incentives over time.

Phase 2 Combating the epidemic of overdose deaths is a central challenge of U.S. health care policy, and substance use disorder (SUD) is increasingly harming older adults. One approach to treating SUD, incentivizing abstinence from substance use, has repeatedly proven effective but has limited evidence base in older populations. A uniquely scalable modality - of increasing interest to policymakers - for implementing this approach is with a mobile application (app) that delivers incentives for abstinence from opioids and stimulants. However, one concern about using an app for incentives is that it may hinder take-up and viability among older populations. Thus, testing the app specifically among older adults is of critical policy importance.

This phase will focus on the effectiveness of the app for older adults (aged 55 and over), and on understanding whether the acceptability and effectiveness of the app is decreasing with older age. Specifically, the primary research aim is to assess whether app-based incentives are effective for older adults. The secondary research aims are to understand whether older adults have lower take-up and engagement with the app than younger adults, and if app effectiveness is mediated by age, thus shedding light on the necessity of age-specific app design features. Effects on abstinence outcomes will be measured for all participants who engage with the app (N=59), and take-up and engagement outcomes will be measured for all participants who are eligible for the randomized controlled trial even if they do not enroll (N=98). It is expected that 15 percent of participants will be older adults. In order to complete the research aims, data will be jointly analyzed from the Roybal-funded study phase and the previous study phase.

The OVERALL AIM is to assess whether app-based incentives are effective for older adults and to quantify the associations between age and both the efficacy and take-up of app-based incentives. This will allow us to determine if older adults with substance use disorders are willing to engage with app-based incentives and whether they perform similarly to their younger counterparts. Because the study will leverage data from an existing study on app-based incentives, a small add-on study is sufficient to address these three aims. This aim will be achieved while simultaneously gathering data that will shed light on the two aims of the first phase of the study: whether app-based incentives are effective overall, and how to optimize the size of incentives over time to maximize their effectiveness.

The results of this intervention will be directly relevant for potential users of this or similar mobile applications for incentive provision among people with substance use disorders, including insurers, treatment facilities, and governments.

Being tested
DynamiCare app (app-based contingency management), Sham control
Keywords
contingency management, reward, abstinence, drugs, substance use disorder
Medical subject headings
Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DynamiCare app (app-based contingency management)Behavioural

    Participants will receive financial incentives for submitting randomly generated drug-negative saliva tests across the intervention period.

  • Sham controlBehavioural

    Participants get access to the DynamiCare app but will not be provided with financial incentives.

Study groups in NCT05521854
Study groupRoleWhat they receive
ControlSham comparatorParticipants in this group will have access to the DynamiCare app; however, no behavioral incentives will be provided to this group.
Receives: Behavioral: Sham control
Escalating LowExperimentalParticipants will have access to the DynamiCare app. Through the app, participants will receive incentive amounts for drug negative saliva tests. Incentive amounts increase with every negative drug test up to a ceiling and "reset" to the lowest amount when a test is positive or missed. The "Low" group will receive lower incentive amounts than the "High" group.
Receives: Behavioral: DynamiCare app (app-based contingency management)
Escalating HighExperimentalParticipants will have access to the DynamiCare app. Through the app, participants will receive incentive amounts for drug negative saliva tests. Incentive amounts increase with every negative drug test up to a ceiling and "reset" to the lowest amount when a test is positive or missed. The "High" group will receive higher incentive amounts than the "Low" group.
Receives: Behavioral: DynamiCare app (app-based contingency management)
De-Escalating LowExperimentalParticipants will have access to the DynamiCare app. Through the app, participants will receive incentive amounts for drug negative saliva tests. Incentive amounts increase with every positive drug tests (up to a ceiling), and decrease by the same increment with every negative drug test (down to a floor). The "Low" group will receive lower incentive amounts than the "High" group.
Receives: Behavioral: DynamiCare app (app-based contingency management)
De-Escalating HighExperimentalParticipants will have access to the DynamiCare app. Through the app, participants will receive incentive amounts for drug negative saliva tests. Incentive amounts increase with every positive drug tests (up to a ceiling), and decrease by the same increment with every negative drug test (down to a floor). The "High" group will receive higher incentive amounts than the "Low" group.
Receives: Behavioral: DynamiCare app (app-based contingency management)
Constant HighExperimentalIn the Constant groups, incentive amounts will remain unchanged across time. The "High" group will receive higher incentive amounts than the "Low" group.
Receives: Behavioral: DynamiCare app (app-based contingency management)
Constant LowExperimentalIn the Constant groups, incentive amounts will remain unchanged across time. The "Low" group will receive lower incentive amounts than the "High" group.
Receives: Behavioral: DynamiCare app (app-based contingency management)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug-negative saliva tests

    Percent of three (3) scheduled video-verified saliva test results classified as drug-negative

    Measured: 3 months

  2. App uptake

    Percent of eligible population which uptakes app

    Measured: Through study completion, an average of 1 year

Secondary outcomes (1)
  1. Longest period of continuous abstinence

    Longest period of continuous abstinence measured using lab-verified in-person urine-tests or video-verified saliva tests

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start1 May 2023
  3. Primary completion26 May 2026
  4. Study completion26 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521854
Sponsor's protocol ID
IRB00106568
Other IDs
22.187E, 10568
Status last verified
Jun 2026
First submitted
15 Aug 2022
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24750232
  • Dickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med. 1999 Jul 15;341(3):198-203. doi: 10.1056/NEJM199907153410312. No abstract available.

    PubMed 10403861
  • Festinger DS, Marlowe DB, Dugosh KL, Croft JR, Arabia PL. Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Drug Alcohol Depend. 2008 Jul 1;96(1-2):128-35. doi: 10.1016/j.drugalcdep.2008.02.007. Epub 2008 Apr 18.

    PubMed 18395365
  • Halpern SD, Chowdhury M, Bayes B, Cooney E, Hitsman BL, Schnoll RA, Lubitz SF, Reyes C, Patel MS, Greysen SR, Mercede A, Reale C, Barg FK, Volpp KG, Karlawish J, Stephens-Shields AJ. Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials. JAMA Intern Med. 2021 Nov 1;181(11):1479-1488. doi: 10.1001/jamainternmed.2021.5450.

    PubMed 34542553
  • 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. doi: 10.1037/tps0000067.

    PubMed 27777964
  • 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. doi: 10.1111/j.1360-0443.2006.01311.x.

    PubMed 16445548
  • 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. doi: 10.1037/0022-006X.74.3.592.

    PubMed 16822115
  • Grant RW, Sugarman J. Ethics in human subjects research: do incentives matter? J Med Philos. 2004 Dec;29(6):717-38. doi: 10.1080/03605310490883046.

    PubMed 15590518
  • 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. doi: 10.1176/appi.ajp.162.2.340.

    PubMed 15677600

Questions about this trial

What is this clinical trial studying?

A study testing DynamiCare app (app-based contingency management) in people with Opioid Use Disorder and Methamphetamine Abuse, run by Wake Forest University Health Sciences at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug-negative saliva tests (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521854, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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