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NCT03543735 · ClinicalTrials.gov registry record · NA
A Targeted, Real-Time, Technology-Supported Intervention for Patients With Alcohol Use Disorder on Disulfiram
A NA study, sponsored by Butler Hospital.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03543735 is a NA study that has completed, run by Butler Hospital. The registered enrollment target is 50 participants.
The verdict
NCT03543735, a NA study, has completed, sponsored by Butler Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Alcohol use disorders (AUDs) are a costly and burdensome health concern, affecting over 15 million adults each year in the United States. Several FDA-approved medication-assisted therapies (MATs) are used for the treatment of AUD, with disulfiram (Antabuse) the oldest and one of the most common. Disulfiram acts as a "psychological deterrent" and causes physiological reactions when taken with alcohol. Despite demonstrated efficacy for decreasing relapse, disulfiram is underutilized: efficacy is best demonstrated under monitoring or supervision, creating a barrier for use. Additionally, disulfiram adherence rates are low. The most common reason for non-adherence is that an individual is contemplating or planning a relapse, which typically occurs within 50 hours. Thus, disulfiram non-adherence can be a marker for relapse, providing a very short window for intervention. Technological advances now allow for electronic medication monitoring: devices are designed to objectively track adherence. The Wisepill device is an electronic medication monitoring system that pairs real-time monitoring with a triggered text message (SMS) when doses are late. The Wisepill device plus medication reminder SMS messages are associated with increased adherence to antiretroviral or diabetic therapy. Though the capability exists, potentially therapeutic SMS messages paired with Wisepill objective monitoring have yet to tested in any population. Indeed, previous research suggests that supportive and relapse prevention/coping skills SMS message interventions are effective in reducing alcohol use. Thus, given that disulfram non-adherence can signify a critical clinical concern (i.e., impending relapse), the delivery of a tailored, relapse prevention-focused, just-in-time SMS soon after disulfiram discontinuation could have a significant impact on AUD treatment outcomes. The investigators propose to develop an intervention capitalizing on the Wisepill technology to pair real-time medication monit
Interventions
- BEHAVIORAL Wisepill+SMS
- OTHER Wisepill-only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2024-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03543735
The ClinicalTrials.gov registry entry for NCT03543735 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Butler Hospital, which has 103 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Wisepill+SMS is the first listed.
NCT03543735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03543735 about?
NCT03543735 is a clinical study titled "A Targeted, Real-Time, Technology-Supported Intervention for Patients With Alcohol Use Disorder on Disulfiram". Alcohol use disorders (AUDs) are a costly and burdensome health concern, affecting over 15 million adults each year in the United States. Several FDA-approved medication-assisted therapies (MATs) are used for the treatment of AUD, with disulfiram (Antabuse) the oldest and one of the most common. Dis...
What is the current status of trial NCT03543735?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2018-11-29. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT03543735?
The interventions under investigation include: Wisepill+SMS (BEHAVIORAL), Wisepill-only (OTHER).
Who is sponsoring clinical trial NCT03543735?
This trial is sponsored by Butler Hospital, which has 103 total clinical trials registered on ClinicalTrials.gov.
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