Incentives to Decrease Opioid Use - Pilot
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ClinicalTrials.gov Identifier: NCT04235582 |
Recruitment Status :
Enrolling by invitation
First Posted : January 22, 2020
Last Update Posted : January 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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Substance-Related Disorders Opioid-Related Disorders Behavior Therapy | Behavioral: App + Inputs Contingency Management Behavioral: App + Outcomes Contingency Management | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Encouraging Opioid Abstinence Behavior: Incentivizing Inputs and Outcomes - Pilot |
Actual Study Start Date : | August 25, 2020 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | October 2021 |
Arm | Intervention/treatment |
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Experimental: Outcomes Group
During 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.
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Behavioral: App + Outcomes Contingency Management
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). |
Experimental: Inputs Group
Will 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:
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Behavioral: App + Inputs Contingency Management
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). |
Experimental: Combination Group
Will 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:
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Behavioral: App + Inputs Contingency Management
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). Behavioral: App + Outcomes Contingency Management 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). |
- Continuous Abstinence from Opioid Use [ Time Frame: Time = 4 weeks ]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).
- Continuous Abstinence from Opioid Use [ Time Frame: Time = 8 weeks ]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).
- Continuous Abstinence from Opioid Use [ Time Frame: Time = 12 weeks ]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).
- Negative Urinalysis Frequency [ Time Frame: Time = Day 0 through 12 weeks ]Percent of standard of care urinalyses results classified as negative
- Negative Saliva Analysis Frequency [ Time Frame: Time = Day 0 through 12 weeks ]Percent of random saliva tests classified as negative
- Psychotherapy Attendance [ Time Frame: Time = Day 0 through 12 weeks ]The percent of psychotherapy visits attended.
- Psychotherapy Completion [ Time Frame: 12 weeks ]Whether or not the patient completed the scheduled psychotherapy program.
- Medication Adherence [ Time Frame: Time = Day 0 through 12 weeks ]% adherence to medication assisted therapies (i.e., % of prescribed medication-assisted treatments taken as prescribed)
- World Health Organization Quality of Life Brief (WHOQOL-BREF) survey [ Time Frame: Week 4 ]Scores on World Health Organization Quality of Life Brief (WHOQOL-BREF) survey on a scale of 1-100 where higher is greater quality of life
- World Health Organization Quality of Life Brief (WHOQOL-BREF) survey [ Time Frame: Week 8 ]Scores on World Health Organization Quality of Life Brief (WHOQOL-BREF) survey on a scale of 1-100 where higher is greater quality of life
- World Health Organization Quality of Life Brief (WHOQOL-BREF) survey [ Time Frame: Week 12 ]Scores on World Health Organization Quality of Life Brief (WHOQOL-BREF) survey on a scale of 1-100 where higher is greater quality of life

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion
- 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;
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Are likely to be helped by contingency management because at least ONE of the following conditions is true:
- 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.
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.
Note that pregnant women are not excluded from participating in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235582
United States, California | |
Univeresity of California - Berkeley | |
Berkeley, California, United States, 94720 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Wisconsin | |
Aurora Psychiatric Hospital | |
Wauwatosa, Wisconsin, United States, 53213 |
Principal Investigator: | Mindy R Waite, PhD | Aurora Health Care, Inc. |
Responsible Party: | Aurora Health Care |
ClinicalTrials.gov Identifier: | NCT04235582 |
Other Study ID Numbers: |
19-1095 |
First Posted: | January 22, 2020 Key Record Dates |
Last Update Posted: | January 29, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
opioid-use disorder substance-use disorder addiction contingency management dynamicare |
Disease Substance-Related Disorders Opioid-Related Disorders |
Pathologic Processes Chemically-Induced Disorders Mental Disorders |