Reward-Based Recovery Outcomes Management for Opioid Use Disorder

NCT04669249 | Completed Results

• 2 other identifiers: 2020-0011R43DA051298-01A1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Fully-Adherent to Buprenorphine

  Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.

  4-week

• Percentage of Participants Fully-Adherent to Care Plan

  Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.

  4-week

• Percentage of Participants Completing Outcomes Monitoring Surveys

  Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.

  4-week

Secondary Outcomes (7)

• Percentage of Participants Using Opioids

  4-week

• Percentage of Participants Using Other Substances (Non-opioids)

  4-week

• Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up

  4-week

• Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up

  4-week

• Motivation as Assessed by Readiness Ruler

  4-week

Other Outcomes (1)

• Usability of PROCare App as Assessed by System Usability Scale (SUS)

  4-week

Study Arms (2)

PROCare

EXPERIMENTAL

Technology-enabled, reward-based recovery platform

Behavioral: PROCare

Control

NO INTERVENTION

Treatment-as-Usual

Interventions

PROCare BEHAVIORAL

PROCare is a reward-based digital recovery management platform for individuals receiving medication treatment for opioid use disorder. Patients have the opportunity to earn both non-monetary and monetary incentives via smart debit card for a variety of clinically-indicated behaviors, including taking their medication (buprenorphine) as directed, attending clinic appointments and community-based mutual-help support group meetings, participating in routine outcomes monitoring surveys using validated measures, accessing the curated psychoeducation content library, and engaging in other recovery-oriented activities within the smartphone app.

PROCare

Eligibility Criteria

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

You may qualify if:

• years of age or older
• access to internet-enabled smartphone device
• primary DSM-5 opioid use disorder diagnosis
• receiving medication treatment for opioid use disorder with buprenorphine
• English language proficient

You may not qualify if:

• active suicidal ideation or psychotic symptoms

Sponsors & Collaborators

• Medical Decision Logic, Inc.: lead
• PRO Health Group: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

South Florida Behavioral Health Network, Inc.

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Recruitment challenges due to COVID-19 pandemic (lower patient volumes/admissions, funding, staff shortages) leading to small numbers of participants analyzed.

Results Point of Contact

• Title: Dr. Steven Proctor
• Organization: PRO Health Group

sproctor@prohealthgroup.net

305-814-7762

Study Officials

• Steven L Proctor, PhD

  PRO Health Group

  PRINCIPAL INVESTIGATOR

• Allen Tien, MD

  Medical Decision Logic, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 16, 2020
• Study Start: March 1, 2022
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: March 17, 2023
• Results First Posted: March 17, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)