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BetterOFF: An App to Aid in Transitioning Off Opioid Medication

Sponsor
Butler Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03077932
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
51
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: App Development and Open Pilot
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Smartphone App to Facilitate Buprenorphine Discontinuation
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Opiate use [1 month post-taper]

    Days of opiate use at follow-up

Secondary Outcome Measures

  1. Fear of withdrawal symptoms [1 month post-taper]

    Fear of withdrawal symptoms

  2. Opiate Withdrawal [Baseline to 1 month post-taper]

    opiate withdrawal symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Butler Hospital Providence Rhode Island United States 02906

Sponsors and Collaborators

  • Butler Hospital

Investigators

  • Principal Investigator: Ana Abrantes, Ph.D., Butler Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT03077932
Other Study ID Numbers:
  • 840059
First Posted:
Mar 13, 2017
Last Update Posted:
Aug 13, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Substance Withdrawal Syndrome

Study Results

No Results Posted as of Aug 13, 2020