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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
Sponsor:
Collaborators:
University of Chicago
University of California, Berkeley
Information provided by (Responsible Party):
Aurora Health Care

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Opioid-Related Disorders Behavior Therapy Behavioral: App + Inputs Contingency Management Behavioral: App + Outcomes Contingency Management Not Applicable

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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
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.
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:

  • Drug adherence to prescribed SUD pharmacotherapy
  • Attendance at individual and group psychotherapy sessions
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:

  • Drug adherence to prescribed SUD pharmacotherapy
  • Attendance at individual and group psychotherapy sessions
  • Random saliva tests
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).




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Negative Urinalysis Frequency [ Time Frame: Time = Day 0 through 12 weeks ]
    Percent of standard of care urinalyses results classified as negative

  2. Negative Saliva Analysis Frequency [ Time Frame: Time = Day 0 through 12 weeks ]
    Percent of random saliva tests classified as negative

  3. Psychotherapy Attendance [ Time Frame: Time = Day 0 through 12 weeks ]
    The percent of psychotherapy visits attended.

  4. Psychotherapy Completion [ Time Frame: 12 weeks ]
    Whether or not the patient completed the scheduled psychotherapy program.

  5. 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)

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  1. Age at least 18 years old;
  2. Meet DSM-5 opioid use disorder criteria as evidenced by an opioid disorder CPT code F11 (opioid related disorders);
  3. Have access to a smartphone (iOS or Android) with data plan and willing to download DynamiCare app;
  4. Are in day (PHP) or partial day (IOP) AODA treatment in Aurora Health's Behavioral Health Program;
  5. Are currently prescribed or will be prescribed within 1-4 days oral buprenorphine for their OUD;
  6. Are likely to be helped by contingency management because at least ONE of the following conditions is true:

    1. Were first enrolled in day or partial day opioid treatment no longer than 1 week prior to providing informed consent.
    2. Currently using non-medical opioids.
    3. Regularly missing scheduled AODA appointments.
  7. Understands English.

Exclusion Criteria:

  1. Have evidence of active (non-substance related) psychosis that might impair participation as determined by the PI.
  2. 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


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Aurora Health Care
University of Chicago
University of California, Berkeley
Investigators
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Principal Investigator: Mindy R Waite, PhD Aurora Health Care, Inc.
Publications:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurora Health Care:
opioid-use disorder
substance-use disorder
addiction
contingency management
dynamicare
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders