Incentive-Based Intervention for Substance Abuse Disorders

Recruiting at 2 trial locations

Overseen By Rebecca Dizon-Ross, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aurora Health Care

Disqualifiers: Active psychosis, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using incentives to encourage abstinence from opioids, cocaine, or methamphetamine, but does not mention other medications.

What data supports the effectiveness of the treatment App-Based Contingency Management for Substance Abuse Disorders?

Research shows that contingency management (CM), which uses rewards to encourage positive behavior, is effective in promoting drug abstinence. A study found that using a smartphone-smartcard platform for CM led to higher rates of drug abstinence and better attendance at counseling appointments. Additionally, CM has been shown to be effective in treating various substance use disorders, including opioid and cocaine use. ^{1 2 3 4 5}

Is incentive-based intervention for substance abuse disorders safe for humans?

The research on incentive-based interventions, like contingency management, shows they are generally safe for humans. These interventions use rewards to encourage positive behaviors, such as drug abstinence, and have been successfully implemented in various settings without significant safety concerns. ^{1 2 3 4 6}

How is the app-based contingency management treatment different from other treatments for substance abuse disorders?

The app-based contingency management treatment is unique because it uses mobile technology to deliver rewards for positive behaviors, like staying drug-free, which can be especially helpful for people in remote areas. This approach makes it easier to provide immediate and personalized incentives, unlike traditional methods that may not be as accessible or adaptable. ^{1 2 3 5 7}

Research Team

Ariel Zucker, PhD

Principal Investigator

University of California Santa Cruz

Eligibility Criteria

This trial is for adults over 18 who have used opioids, cocaine, or methamphetamine non-medically in the last 21 days. Participants must be currently receiving some form of substance abuse treatment and meet specific medical criteria for substance use disorders. They need to have a smartphone with a data plan, an email they can access on their phone, and be willing to download and use the DynamiCare app.

Inclusion Criteria

Have an email and can access it from their smartphone

I am currently in a substance abuse treatment program.

Used non-medical opioids, cocaine, and/or methamphetamine within the last 21 days

Exclusion Criteria

Have evidence of active (non-substance related) psychosis that might impair participation as determined by the PI

I do not have severe cognitive issues that require a legal guardian.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive incentives for drug-negative saliva tests using the DynamiCare app, with varying incentive schedules (escalating, de-escalating, constant).

12 weeks

Remote monitoring via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• App-Based Contingency Management
• Sham Control

Trial Overview The study tests two incentive-based approaches using an app called DynamiCare to promote abstinence from drug use among individuals with opioid or cocaine addiction. One approach increases rewards over time (escalating), while the other decreases them (de-escalating) as participants demonstrate continued abstinence.

Participant Groups

Group I: Escalating Low Experimental Treatment 1 Intervention

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 incentives worth $2-$8.

Group II: Escalating High Experimental Treatment 1 Intervention

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 incentives worth $4-$16.

Group III: De-Escalating Low Experimental Treatment 1 Intervention

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 incentives worth $6-12.

Group IV: De-Escalating High Experimental Treatment 1 Intervention

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 incentives worth $10-$20.

Group V: Constant Low Experimental Treatment 1 Intervention

In the Constant groups, incentive amounts will remain unchanged across time. The "Low" group will receive incentives worth $8 every test.

Group VI: Constant High Experimental Treatment 1 Intervention

In the Constant groups, incentive amounts will remain unchanged across time. The "High" group will receive incentives worth $16.

Group VII: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Aurora Health Care

Lead Sponsor

Trials

46

Recruited

16,400+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of California Santa Cruz

Lead Sponsor

Trials

7

Recruited

2,300+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of California, Santa Cruz

Collaborator

Trials

5

Recruited

2,100+

Rogers Behavioral Health

Collaborator

Trials

3

Recruited

1,200+

Findings from Research

The integrated smartphone-smartcard platform significantly improved counseling appointment attendance and drug abstinence rates among 85 adults with opioid use disorder over a four-month period, showing a 9.6%-18.0% increase in attendance and an odds ratio of 4.84 for drug abstinence compared to matched controls.

Participants overwhelmingly found the platform acceptable, indicating that this technology could help overcome barriers to the adoption of contingency management (CM) interventions in treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. DeFulio, A., Rzeszutek, MJ., Furgeson, J., et al.[2021]

A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.

Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

Contingency management (CM) is an effective behavior-modification method for treating substance-use disorders (SUDs), and this review analyzed 31 studies to explore its advancements and applications.

Emerging technologies, such as mobile delivery systems and new biomarkers, can enhance CM's effectiveness by personalizing interventions and making them accessible to underserved populations, particularly in hard-to-reach areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of contingency management for the treatment of substance-use disorders: adaptation for underserved populations, use of experimental technologies, and personalized optimization strategies. McPherson, SM., Burduli, E., Smith, CL., et al.[2020]

In a study involving 34 individuals with Cocaine Use Disorder, larger fixed incentives for providing negative urine samples led to faster and more effective abstinence compared to smaller incentives.

The type of incentive structure (escalating and resetting vs. fixed) did not significantly impact the overall effectiveness, suggesting that the magnitude of the incentive is more crucial for promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. Regnier, SD., Strickland, JC., Stoops, WW.[2023]

In a 12-week study involving 161 adults with alcohol dependence, higher-magnitude contingency management (CM-H) significantly reduced the average number of positive breath samples, indicating less alcohol use during the intervention.

Participants in the CM-H group had a higher rate of abstinence during follow-up, suggesting that home-based CM with sufficient incentives can effectively support long-term abstinence from alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Contingency Management Delivered by Community Health Workers to Improve Alcohol Abstinence: A Randomized Control Trial. Jirapramukpitak, T., Pattanaseri, K., Chua, KC., et al.[2020]

Internet-based deposit contracts for smoking cessation were effective in increasing the number of breath samples meeting the carbon monoxide criterion, with 47% success in Experiment 1 and 41.5% in Experiment 2, compared to virtually no success during baseline measurements.

Participants found the deposit contract interventions acceptable and feasible, indicating a positive reception that could support further research into their long-term effectiveness for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based self-tailored deposit contracts to promote smoking reduction and abstinence. Jarvis, BP., Dallery, J.[2018]

The study found that using a prize-based contingency management approach significantly increased compliance with daily interactive voice response (IVR) calls, with participants in the prize group being 4.7 times more likely to call than those in the fixed dollar group.

Higher rates of IVR calls were linked to better outcomes in cocaine abstinence, suggesting that engaging participants through innovative reward systems can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using prize-based incentives to enhance daily interactive voice response (IVR) compliance: a feasibility study. Lindsay, JA., Minard, CG., Hudson, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A review of contingency management for the treatment of substance-use disorders: adaptation for underserved populations, use of experimental technologies, and personalized optimization strategies. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Home-Based Contingency Management Delivered by Community Health Workers to Improve Alcohol Abstinence: A Randomized Control Trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Internet-based self-tailored deposit contracts to promote smoking reduction and abstinence. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Using prize-based incentives to enhance daily interactive voice response (IVR) compliance: a feasibility study. [2021]