A Targeted, Real-Time, Technology-Supported Intervention for Patients With Alcohol Use Disorder on Disulfiram

NCT03543735 | Completed

• 1 other identifier: 1804-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Drinking, Alcohol

Outcome Measures

Primary Outcomes (6)

• Timeline Followback (TLFB) for alcohol use

  Alcohol use, yes/no for last 90 days or since last assessment

  6 months

• Alcohol breath analysis

  Breathalyser

  6 months

• PEth blood alcohol testing

  Biological measure of alcohol use

  6 months

• Wisepill adherence counts

  Record of use of Wisepill pillbox

  6 months

• Zenalyser Antabuse breath compliance test

  Test of disulfiram (Antabuse) metabolites

  6 months

• Self-reported medication adherence

  Self-reported use of disulfiram

  6 months

Secondary Outcomes (3)

• Multidimensional Scale of Perceived Social Support

  6 months

• Alcohol Abstinence Self-Efficacy Scale

  6 months

• Brief COPE

  6 months

Study Arms (3)

Wisepill+SMS

EXPERIMENTAL

Behavioral: Wisepill+SMS

Wisepill-only

ACTIVE COMPARATOR

Other: Wisepill-only

Disulfiram-only

NO INTERVENTION

Interventions

Wisepill+SMS BEHAVIORAL

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).

Wisepill+SMS

Wisepill-only OTHER

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.

Wisepill-only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 65 years of age
• meet DSM-5 criteria for an AUD, as assessed by the SCID-P,
• prescribed disulfiram while in the Alcohol and Drug Partial Hospital Program (i.e., while also meeting psychiatrist criteria for a disulfiram protocol)
• are currently enrolled in ADP
• has access to a phone capable of receiving SMS and access to email.

You may not qualify if:

• current DSM-5 diagnosis moderate/severe substance use disorder
• a history of psychotic disorder or current psychotic symptoms
• current suicidality or homicidality
• current use of an alcohol treatment medication other than disulfiram.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Disulfiram usage

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: November 29, 2018
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)