A Targeted, Real-Time, Technology-Supported Intervention for Patients With Alcohol Use Disorder on Disulfiram (Wisepill+SMS)
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|ClinicalTrials.gov Identifier: NCT03543735|
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : December 12, 2018
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 monitoring with tailored (a) real-time triggered reminders, (b) real-time abstinence support, and (c) relapse prevention SMS texts for individuals with AUD being treated with disulfram.
The investigators propose to develop a 12-week Wisepill+SMS intervention for individuals in alcohol treatment on disulfiram. This will include: 1) an in-person Wisepill orientation session to introduce the device and generate tailored relapse prevention messages; 2) use of the Wisepill device during the intensive treatment program and after discharge; 3) tailored SMS messages paired with use of the Wisepill device: a) supportive messages with medication compliance, b) reminder messages for early non-adherence (e.g., 1 hour late) and c) relapse-prevention messages after longer periods of non-adherence (e.g., several hours). The goal of this application is to develop the Wisepill+SMS intervention with the aid of focus groups (n=20), then test the Wisepill+SMS intervention in a RCT (n=75) comparing Wisepill+SMS to Wisepill only (i.e., no SMS) and disulfiram only (i.e., no Wisepill, no SMS). The Wisepill device, and its associated real-time monitoring and messaging systems, are relatively low-cost, easy to program, and can deliver an intervention that would reduce barriers to care.
|Condition or disease||Intervention/treatment||Phase|
|Drinking, Alcohol||Behavioral: Wisepill+SMS Other: Wisepill-only||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Targeted, Real-Time, Technology-Supported Intervention for Patients With Alcohol Use Disorder on Disulfiram|
|Actual Study Start Date :||November 29, 2018|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 30, 2021|
This will include: 1) an in-person Wisepill orientation session to introduce the pillbox and generate relapse prevention messages that can be later delivered during non-adherent windows; 2) use of the Wisepill device during the intensive treatment program and after discharge; and 3) three forms of tailored SMS messages paired with Wisepill device use: a) supportive messages with medication compliance, b) reminder messages for early non-adherence (e.g., 1 hour late) and c) relapse-prevention messages after longer periods of non-adherence (e.g., several hours).
|Active Comparator: Wisepill-only||
This will include: 1) an in-person Wisepill orientation session to introduce the pillbox; 2) use of the Wisepill during the intensive treatment program and after discharge.
|No Intervention: Disulfiram-only|
- Timeline Followback (TLFB) for alcohol use [ Time Frame: 6 months ]Alcohol use, yes/no for last 90 days or since last assessment
- Alcohol breath analysis [ Time Frame: 6 months ]Breathalyser
- PEth blood alcohol testing [ Time Frame: 6 months ]Biological measure of alcohol use
- Wisepill adherence counts [ Time Frame: 6 months ]Record of use of Wisepill pillbox
- Zenalyser Antabuse breath compliance test [ Time Frame: 6 months ]Test of disulfiram (Antabuse) metabolites
- Self-reported medication adherence [ Time Frame: 6 months ]Self-reported use of disulfiram
- Multidimensional Scale of Perceived Social Support [ Time Frame: 6 months ]Perceived social support, 12 items (measured 1-7, total=12-84, higher=more perceived support)
- Alcohol Abstinence Self-Efficacy Scale [ Time Frame: 6 months ]Belief in ability to abstain from alcohol, 40 items (measured 0-4, total=0-160, higher=more self-efficacy)
- Brief COPE [ Time Frame: 6 months ]Coping skills and strategies, 28 items (measured 1-4) and 14 subscales. Subscale scores will be used (range in scores = 2-8, higher=more use of coping strategy)
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): NCT03543735
|Contact: Claire E Blevins, PhDfirstname.lastname@example.org|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Contact: Claire E Blevins, PhD|