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An App to Aid in Transitioning Off Opioid Medication (BetterOFF)

Primary Purpose

Opiate Use Disorder, Opiate Withdrawal Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App Development and Open Pilot
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

App Development and Open Pilot

Arm Description

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.

Outcomes

Primary Outcome Measures

Opiate use
Days of opiate use at follow-up

Secondary Outcome Measures

Fear of withdrawal symptoms
Fear of withdrawal symptoms
Opiate Withdrawal
opiate withdrawal symptoms

Full Information

First Posted
March 8, 2017
Last Updated
August 12, 2020
Sponsor
Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03077932
Brief Title
An App to Aid in Transitioning Off Opioid Medication
Acronym
BetterOFF
Official Title
A Smartphone App to Facilitate Buprenorphine Discontinuation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Use Disorder, Opiate Withdrawal Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App Development and Open Pilot
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
App Development and Open Pilot
Intervention Description
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 Outcome Measure Information:
Title
Opiate use
Description
Days of opiate use at follow-up
Time Frame
1 month post-taper
Secondary Outcome Measure Information:
Title
Fear of withdrawal symptoms
Description
Fear of withdrawal symptoms
Time Frame
1 month post-taper
Title
Opiate Withdrawal
Description
opiate withdrawal symptoms
Time Frame
Baseline to 1 month post-taper

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Abrantes, Ph.D.
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An App to Aid in Transitioning Off Opioid Medication

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