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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077932
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Butler Hospital

Study Description
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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
Opiate Use Disorder Opiate Withdrawal Syndrome Other: App Development and Open Pilot Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : April 1, 2016
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020
Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Opiate use [ Time Frame: 1 month post-taper ]
    Days of opiate use at follow-up


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077932


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
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Principal Investigator: Ana Abrantes, Ph.D. Butler Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT03077932    
Other Study ID Numbers: 840059
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders