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Substance-Related DisordersNCT04235582

Incentives to Decrease Opioid Use - Pilot

A study testing App + Inputs Contingency Management and App + Outcomes Contingency Management in people with Substance-Related Disorders and Opioid-Related Disorders, run by Wake Forest University Health Sciences at 3 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 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
App + Inputs Contingency Management and App + Outcomes Contingency Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesUnited States
Study dates
25 Aug 2020to 15 May 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 opioid use disorder criteria as evidenced by an opioid disorder CPT code F11 (opioid related disorders);
  • Have access to a smartphone (iOS or Android) with data plan and willing to download DynamiCare app;
  • Are in day (PHP) or partial day (IOP) AODA treatment in Aurora Health's Behavioral Health Program;
  • Are currently prescribed or will be prescribed within 1-4 days oral buprenorphine for their OUD;
  • Are likely to be helped by contingency management because at least ONE of the following conditions is true:
Show all 10Show fewer
  • Were first enrolled in day or partial day opioid treatment no longer than 1 week prior to providing informed consent.
  • Currently using non-medical opioids.
  • Regularly missing scheduled AODA appointments.
  • 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.
  • Note that pregnant women are not excluded from participating in the study

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of California - Santa Cruz

    Berkeley, California, 94720

  • University of Chicago

    Chicago, Illinois, 60637

  • Aurora Psychiatric Hospital

    Wauwatosa, Wisconsin, 53213

Other trials in United States

About this study

Official title: Encouraging Opioid Abstinence Behavior: Incentivizing Inputs and Outcomes - Pilot

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.

Read the detailed description

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. Similar effects have been demonstrated repeatedly across a wealth of populations, substance-abuse disorders, and payment methodologies.

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. 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.

This will be the first randomized evaluation of an innovative, scalable incentives program for opioid addiction delivered through a mobile application. The application, which was developed by our implementing partner, DynamiCare Health, 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 will address two key knowledge gaps in the logistics of existing incentive program design for opioid addiction. First, the first technology t for remote monitoring of abstinence behavior for opioid use will be tested. 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 this study promises to do the same for opioid addiction. 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. This technology allows patients to receive incentives almost immediately following the undertaking of the incentivized behavior: a first in incentives for opioid addiction.

Another novel feature of this design is that can allow assessment of a gap in the literature on incentive delivery: comparing both the isolated effects of incentives and of the monitoring needed to implement an incentive program. In addition to a control group, this study includes both monitoring groups and incentives groups. While existing literature on incentives for addiction has included either a monitoring group or a control group, this is the first to include both, such that a comparison can be made between incentives that are distal (inputs) and proximal (outcome) to the targeted abstinence behavior.

Finally, this study will directly address two key open questions in the literature on incentives for drug-users. 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. Similarly designed studies did not detect different effects on abstinence from incentivizing treatment attendance and incentivizing cocaine abstinence among cocaine users (both were effective): however, not only was this study for a different substance use disorder, but because of differential rates of test submission among these two groups, the results were not conclusive. This study will similarly compare two versions of the incentive program: one that incentivizes inputs to achieving abstinence, and one that incentivizes the outcome of abstinence. To address differential test submission rates, the impacts of the intervention will be measured via urine drug-tests administered identically to patients in both treatments.

The second question is how to optimize the size of incentives over time to maximize incentive effectiveness. This will be assessed by randomly varying the size and timing of incentives offered to participants in both the Inputs and Outcomes groups. The variation in incentive amounts 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.

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

Being tested
App + Inputs Contingency Management, App + Outcomes Contingency Management
Keywords
opioid-use disorder, substance-use disorder, addiction, contingency management, dynamicare
Medical subject headings
Substance-Related Disorders, Opioid-Related Disorders, Behavior, Addictive

What participants receive

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

  • App + Inputs Contingency ManagementBehavioural

    The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).

  • App + Outcomes Contingency ManagementBehavioural

    The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).

Study groups in NCT04235582
Study groupRoleWhat they receive
Outcomes GroupExperimentalDuring the intervention period, the "Outcomes" group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use.
Receives: Behavioral: App + Outcomes Contingency Management
Inputs GroupExperimentalWill receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions
Receives: Behavioral: App + Inputs Contingency Management
Combination GroupExperimentalWill receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions * Random saliva tests
Receives: Behavioral: App + Inputs Contingency Management; Behavioral: App + Outcomes Contingency Management

What is being measured

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

  1. 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).

    Measured: Time = 4 weeks

  2. 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).

    Measured: Time = 8 weeks

  3. 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

    Measured: Time = 12 weeks

Timeline

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

  1. First posted22 Jan 2020
  2. Study start25 Aug 2020
  3. Primary completion1 May 2021
  4. Study completion15 May 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235582
Sponsor's protocol ID
19-1095
Status last verified
Jan 2021
First submitted
20 Nov 2019
Last updated
3 Oct 2024
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
  • 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
  • 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 App + Inputs Contingency Management and App + Outcomes Contingency Management in people with Substance-Related Disorders and Opioid-Related Disorders, run by Wake Forest University Health Sciences at 3 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 10 inclusion and 3 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Continuous Abstinence From Opioid Use (time frame: Time = 4 weeks). The study lists 3 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 NCT04235582, which also lists 5 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 3 Oct 2024.

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