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An App to Aid in Transitioning Off Opioid Medication

A Smartphone App to Facilitate Buprenorphine Discontinuation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077932
Acronym
BetterOFF
Enrollment
15
Registered
2017-03-13
Start date
2016-04-01
Completion date
2020-06-30
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Use Disorder, Opiate Withdrawal Syndrome

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.

Interventions

OTHERApp 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.

Sponsors

Butler Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Opiate use1 month post-taperDays of opiate use at follow-up

Secondary

MeasureTime frameDescription
Fear of withdrawal symptoms1 month post-taperFear of withdrawal symptoms
Opiate WithdrawalBaseline to 1 month post-taperopiate withdrawal symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026