NCT05521854

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2023Jun 2026

First Submitted

Initial submission to the registry

August 15, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

August 15, 2022

Last Update Submit

March 16, 2026

Conditions

Keywords

contingency managementrewardabstinencedrugssubstance use disorder

Outcome Measures

Primary Outcomes (2)

  • Drug-negative saliva tests

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

    3 months

  • App uptake

    Percent of eligible population which uptakes app

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Longest period of continuous abstinence

    3 months

Study Arms (7)

Control

SHAM COMPARATOR

Participants in this group will have access to the DynamiCare app; however, no behavioral incentives will be provided to this group.

Behavioral: Sham control

Escalating Low

EXPERIMENTAL

Participants 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.

Behavioral: DynamiCare app (app-based contingency management)

Escalating High

EXPERIMENTAL

Participants 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.

Behavioral: DynamiCare app (app-based contingency management)

De-Escalating Low

EXPERIMENTAL

Participants 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.

Behavioral: DynamiCare app (app-based contingency management)

De-Escalating High

EXPERIMENTAL

Participants 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.

Behavioral: DynamiCare app (app-based contingency management)

Constant High

EXPERIMENTAL

In the Constant groups, incentive amounts will remain unchanged across time. The "High" group will receive higher incentive amounts than the "Low" group.

Behavioral: DynamiCare app (app-based contingency management)

Constant Low

EXPERIMENTAL

In the Constant groups, incentive amounts will remain unchanged across time. The "Low" group will receive lower incentive amounts than the "High" group.

Behavioral: DynamiCare app (app-based contingency management)

Interventions

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

Constant HighConstant LowDe-Escalating HighDe-Escalating LowEscalating HighEscalating Low
Sham controlBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Advocate Health Care

Chicago, Illinois, 60007, United States

Location

Aurora Behavioral Health Services

Milwaukee, Wisconsin, 53213, United States

Location

Related Publications (9)

  • 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.

    PMID: 24750232BACKGROUND
  • 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.

    PMID: 10403861BACKGROUND
  • 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.

    PMID: 18395365BACKGROUND
  • 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.

    PMID: 34542553BACKGROUND
  • 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.

    PMID: 27777964BACKGROUND
  • 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.

    PMID: 16445548BACKGROUND
  • 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.

    PMID: 16822115BACKGROUND
  • 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.

    PMID: 15590518BACKGROUND
  • 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.

    PMID: 15677600BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mercedes Robaina

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
  • Ariel Zucher, PhD

    University of California Santa Cruz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 30, 2022

Study Start

May 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations