An App to Aid in Transitioning Off Opioid Medication

NCT ID: NCT03077932

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2020-06-30

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.

Conditions

Opiate Use Disorder; Opiate Withdrawal Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

App Development and Open Pilot

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Abrantes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

840059

Identifier Type: -

Identifier Source: org_study_id