Substance Use Disorder Trial Deploys App for Treatment Adherence and Collection of Daily Subject Reports on Drug and Alcohol Use

Research into substance use disorder treatments is complex and evolving, uniquely shaped by scientific advancements, societal attitudes, and the changing nature of substance use disorders themselves.

Patients with substance use disorders often exhibit poor medication adherence, which can lead to inconsistent treatment outcomes and reduced effectiveness of the tested medication.1 Substance abuse can directly and indirectly impact medication compliance, as active substance use or association with substance users can lead to disorganized lifestyles and reduced focus on adhering to medication regimens.2

Cocaine use disorder (CUD) has emerged as one of the more urgent targets of clinical research, and research into Cocaine and other Psychostimulant Use Disorders is a continued research priority for the US National Institute on Drug Abuse (NIDA).2 CUD – the compulsive use of cocaine despite its medical, psychological, and behavioral consequences – is a severe public health problem, affecting millions of people globally.3 In the United States (US) alone, approximately 2.2 million people use cocaine regularly (compared to 600,000 methamphetamine users), 1.5 million of whom meet the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for CUD.4

Research has been conducted to evaluate the efficacy of various psychosocial and pharmacological interventions for CUD.4 While there are no FDA-approved pharmacological treatments for CUD, the most promising strategies for CUD treatment thus far include the use of dopamine agonists, such as long-acting amphetamine and modafinil or glutamatergic and GABAergic agents such as topiramate.5

Participants track dosing and report alcohol and substance use in real-time in a NIDA-funded trial

McCann and colleagues recently published results of a randomized, double-blind, placebo-controlled trial sponsored by NIDA which deployed AiCure medication adherence technology for participants to record the dosing of the study drug. Researchers implemented the AiCure smartphone app to capture and analyze dosing behavior using smartphone video, computer vision and machine learning. Additionally, participants were asked to report on their daily alcohol and cocaine intake using an integrated substance use diary within the Patient Connect application, providing an additional data source to support administration of the Timeline Follow-Back (TLFB). Learn more in the AiCure Patient Connect fact sheet.

In the CUD study supported by AiCure, smartphones were issued by the clinical sites. The app is also frequently used in trials that allow participants to use their own device.

Click here to read the original research article in Drug and Alcohol Dependence

“Medication nonadherence is a significant methodological consideration in clinical trials focused on all indications, but it can present an especially challenging obstacle when developing novel pharmacologic treatment options for substance use disorders. In part, this is due to the fluctuating commitment of patients to their treatment goals. Our trial design incorporated several novel elements, including the use of a run-in period to enrich the efficacy population for participants more likely to adhere to study drug, and use of the AiCure platform to monitor and encourage compliance with the study drug dosing. I am excited about the potential for this technology to improve data integrity in trials evaluating new medications for patients living with substance use disorders.”

David McCann, SUD Solutions LLC (retired from NIH/NIDA Division of Therapeutics and Medical Consequences)

Using AiCure adherence technology in clinical trials for substance use disorder treatments can offer several advantages over other options for medication adherence, including:

  1. Immediate monitoring and confirmation of medication ingestion: AiCure uses computer vision and machine learning to visually confirm that the right patient is taking the right medication at the right time. This can be an advantage over interventions that are unable to confirm a study drug was taken by the patient.

  2. Remote patient engagement and personalized care: AiCure's platform provides real-time dosing instructions and can be configured specifically to any clinical research plan. This personalized approach may improve medication adherence and patient engagement, leading to more complete and reliable results.

  3. Predictive analytics and data-driven insights: AiCure uses advanced data analytics to predict adherence. This allows for the planning of possible intervention and mitigation strategies to improve patient adherence during trials.

  4. Flexibility to support various types of trials: AiCure supports the entire spectrum of trials, from traditional site-based trials to virtual and hybrid trials. This flexibility can be particularly beneficial in the context of substance use disorder treatments, where the nature and severity of the disorder, as well as the willingness to engage in a trial, can vary widely among patients.

  5. Improved data quality: AiCure can improve data quality in clinical trials by helping identify issues with specific sites or types of patients, which can inform future study planning, protocol design, and site management strategies.

Contact AiCure for questions about determining the right mix of medication adherence methods to keep participants engaged in your substance use disorder clinical trials.

We look forward to hearing from you.

1Factors associated with medication adherence among psychiatric outpatients at substance abuse risk


3Cocaine Use Disorder (CUD): Current Clinical Perspectives - PMC

4Cocaine Use Disorder (CUD): Current Clinical Perspectives - PMC

5The treatment of cocaine use disorder - PMC