An App to Aid in Transitioning Off Opioid Medication

Opiate Withdrawal Syndrome Clinical Trial

— BetterOFF  

Official title:

A Smartphone App to Facilitate Buprenorphine Discontinuation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077932
• Other study ID #: 840059
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opiate Use Disorder
• Opiate Withdrawal Syndrome
• Substance Withdrawal Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate use	Days of opiate use at follow-up	1 month post-taper
Secondary	Fear of withdrawal symptoms	Fear of withdrawal symptoms	1 month post-taper
Secondary	Opiate Withdrawal	opiate withdrawal symptoms	Baseline to 1 month post-taper