Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial.

Background: Alcohol use disorder is a chronic disorder with a high likelihood of relapse. The consistent monitoring of blood alcohol concentration through breathalyzers is critical to identifying relapse or misuse. Smartphone apps as a replacement of or in conjunction with breathalyzers have shown limited effectiveness. Yet, there has been little research that has effectively utilized wireless or Wi-Fi-enabled breathalyzers that can accurately, securely, and reliably measure blood alcohol concentration.

Objective: The purpose of this study is to evaluate the impact of a wireless blood alcohol concentration device in collaboration with long-term treatment on dropout rates, psychological distress, treatment motivation, quality of life, and need for higher levels of follow-up care for patients with alcohol use disorder.

Methods: The randomized clinical trial will include two arms, access to the wireless breathalyzer versus no access to the breathalyzer, while both groups have access to treatment. Evaluation will last 3 months with a 6-week follow-up, during which each participant will be interviewed at admission, 1 month in, 2 months in, 3 months in, and follow-up. Individuals will be recruited online through a secure telehealth meeting invitation. Outcomes will focus on the impact of the wireless breathalyzer within the alcohol use disorder population, and the combined effect on psychological distress, treatment motivation, and quality of life. In addition, we intend to investigate the impact of the breathalyzer on dropout rates and participants' need for higher levels of follow-up care and treatment.

Results: The recruitment of this study started in July 2020 and will run until 2022.

Conclusions: This information will be important to develop cost-effective treatments for alcohol dependence. Ongoing monitoring allows treatment providers to take an individualized disease management approach and facilitates timely intervention by the treatment provider.

Trial Registration: ClinicalTrials.gov NCT04380116; http://clinicaltrials.gov/ct2/show/NCT04380116.

International Registered Report Identifier (irrid): DERR1-10.2196/30186.