Incentives to Decrease Opioid Use - Pilot

NCT04235582 | Completed Results

• 1 other identifier: 19-1095
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Behavior Therapy

Keywords

opioid-use disorder; substance-use disorder; addiction; contingency management; dynamicare

Outcome Measures

Primary Outcomes (3)

• 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).

  Time = 4 weeks

• 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).

  Time = 8 weeks

• 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

  Time = 12 weeks

Study Arms (3)

Outcomes Group

EXPERIMENTAL

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

Inputs Group

EXPERIMENTAL

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

Combination Group

EXPERIMENTAL

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; Behavioral: App + Outcomes Contingency Management

Interventions

App + Inputs Contingency Management BEHAVIORAL

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).

Combination Group; Inputs Group

App + Outcomes Contingency Management BEHAVIORAL

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).

Combination Group; Outcomes Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

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.
• Note that pregnant women are not excluded from participating in the study

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of Chicago: collaborator
• University of California, Berkeley: collaborator

Study Sites (3)

University of California - Santa Cruz

Berkeley, California, 94720, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Aurora Psychiatric Hospital

Wauwatosa, Wisconsin, 53213, United States

Location

Related Publications (5)

• 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: 24750232 BACKGROUND

• 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: 27777964 BACKGROUND

• 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: 16445548 BACKGROUND

• 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: 16822115 BACKGROUND

• 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: 15677600 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Behavior, Addictive

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This is a pilot and feasibility study with relatively few enrollees.

Results Point of Contact

• Title: Mindy Waite, Behavioral Health Research Scientist
• Organization: Aurora Health Care

mindy.waite@aah.org

414-773-4323

Study Officials

• Michael Fendrich, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: January 22, 2020
• Study Start: August 25, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 15, 2021
• Last Updated: October 3, 2024
• Results First Posted: August 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)