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OpenTrials
Completed

NCT Number: NCT03077932

An App to Aid in Transitioning Off Opioid Medication

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App Development and Open Pilot

Other

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 outcomes

  1. Opiate use

    Time frame: 1 month post-taper

    Days of opiate use at follow-up

Secondary outcomes

  1. Fear of withdrawal symptoms

    Time frame: 1 month post-taper

    Fear of withdrawal symptoms

  2. Opiate Withdrawal

    Time frame: Baseline to 1 month post-taper

    opiate withdrawal symptoms

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Official study title

A Smartphone App to Facilitate Buprenorphine Discontinuation

Acronym: BetterOFF

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2017
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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