An App to Aid in Transitioning Off Opioid Medication

Not Applicable

Completed

• Conditions: Opiate Withdrawal Syndrome; Opiate Use Disorder
• Interventions: Other: App Development and Open Pilot

• Registration Number: NCT03077932
• Lead Sponsor: Butler Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

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Exclusion Criteria

• non-English speaking.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
App Development and Open Pilot	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.

Primary Outcome Measures

Name	Time	Method
Opiate use	1 month post-taper	Days of opiate use at follow-up

Secondary Outcome Measures

Name	Time	Method
Fear of withdrawal symptoms	1 month post-taper	Fear of withdrawal symptoms
Opiate Withdrawal	Baseline to 1 month post-taper	opiate withdrawal symptoms

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States