An App to Aid in Transitioning Off Opioid Medication
BetterOFF
A Smartphone App to Facilitate Buprenorphine Discontinuation
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 13, 2020
August 1, 2020
4.2 years
March 8, 2017
August 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Opiate use
Days of opiate use at follow-up
1 month post-taper
Secondary Outcomes (2)
Fear of withdrawal symptoms
1 month post-taper
Opiate Withdrawal
Baseline to 1 month post-taper
Study Arms (1)
App Development and Open Pilot
OTHERPhase 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- between 18-65 years of age;
- currently receiving opioid medication;
- interesting in discontinuing opioid medication
- has a smartphone
You may not qualify if:
- non-English speaking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
Study Sites (1)
Butler Hospital
Providence, Rhode Island, 02906, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Abrantes, Ph.D.
Butler Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 13, 2017
Study Start
April 1, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 13, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share