An App to Aid in Transitioning Off Opioid Medication (BetterOFF)

A Smartphone App to Facilitate Buprenorphine Discontinuation

The investigators propose to develop a smartphone app (called BetterOFF) that will help patients manage opioid withdrawal during opioid medication taper and detoxification. The BetterOFF smartphone intervention will be a resource patients can access anytime and anywhere. If the BetterOFF intervention were to be effective in helping patients discontinue opioid medication, it could be integrated into the standard of care of office-based clinical practices, as well as substance use programs, thereby having a substantial public health impact.

Study Overview

• Status: Completed
• Conditions: Opiate Withdrawal Syndrome; Opiate Use Disorder
• Intervention / Treatment: Other: App Development and Open Pilot

Detailed Description

Many of the growing number of patients prescribed long-term opioid medication (for a variety of reasons including a history of illicit opioid use or management of chronic pain) will express an interest in discontinuing medication. However, many patients, physically dependent on opioids, fear the withdrawal symptoms that inevitably occur with opioid medication discontinuation and will experience a decrease in their self-efficacy for abstinence at the end of a taper. As a result, tapering is often slow and done hesitantly, and relapse rates after an opioid taper are high and associated with broad consequences, including significant negative physical, mental, and social problems. Even with optimal tapering protocols, patients need novel approaches to manage the discontinuation of opiate agonist treatment. Given this important gap in opioid treatment delivery, we propose to develop a theoretically-driven, smartphone-delivered intervention (Better Off app) to help patients effectively manage the experience of opioid medication discontinuation.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between 18-65 years of age;
• currently receiving opioid medication;
• interesting in discontinuing opioid medication
• has a smartphone

Exclusion Criteria:

• non-English speaking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: App Development and Open Pilot; Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication. Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.

Other: App Development and Open Pilot; Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication. Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opiate use	Days of opiate use at follow-up	1 month post-taper

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of withdrawal symptoms	Fear of withdrawal symptoms	1 month post-taper
Opiate Withdrawal	opiate withdrawal symptoms	Baseline to 1 month post-taper

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Ana Abrantes, Ph.D., Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome
• Other Study ID Numbers: 840059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No