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Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology.

ABSTRACT: Cocaine use in clinical trials is often measured via self-report, which can be inaccurate, or urine drug screens, which can be intrusive and burdensome. Devices that can automatically detect cocaine use and can be worn conveniently in daily life may provide several benefits. AutoSense is a wearable, physiological-monitoring suite that can detect cocaine use, but it may be limited as a method for monitoring cocaine use because it requires wearing a chestband with electrodes. This paper describes the design, rationale, and methodology of a project that seeks to build upon and extend previous work in the development of methods to detect cocaine use via wearable, unobtrusive mobile sensor technologies. To this end, a wrist-worn sensor suite (i.e., MotionSense HRV) will be developed and evaluated. Participants who use cocaine (N?=?25) will be asked to wear MotionSense HRV and AutoSense for two weeks during waking hours. Drug use will be assessed via thrice-weekly urine drug screens and self-reports, and will be used to isolate periods of cocaine use that will be differentiated from other drug use. The present study will provide information on the feasibility and acceptability of using a wrist-worn device to detect cocaine use.

SUBMITTER: Holtyn AF

PROVIDER: S-EPMC6582185 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology.

Holtyn August F AF Bosworth Eugene E Marsch Lisa A LA McLeman Bethany B Meier Andrea A Saunders Elizabeth C EC Ertin Emre E Ullah Md Azim MA Samiei Shahin Alan SA Hossain Monowar M Kumar Santosh S Preston Kenzie L KL Vahabzadeh Massoud M Shmueli-Blumberg Dikla D Collins Julia J McCormack Jennifer J Ghitza Udi E UE

Contemporary clinical trials communications 20190604

Cocaine use in clinical trials is often measured via self-report, which can be inaccurate, or urine drug screens, which can be intrusive and burdensome. Devices that can automatically detect cocaine use and can be worn conveniently in daily life may provide several benefits. AutoSense is a wearable, physiological-monitoring suite that can detect cocaine use, but it may be limited as a method for monitoring cocaine use because it requires wearing a chestband with electrodes. This paper describes ...[more]

PMID: 31245651

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Project description:Psychotic depression (PD) is a severe disabling disorder with considerable morbidity and mortality. Electroconvulsive therapy and pharmacotherapy are each efficacious in the treatment of PD. Expert guidelines recommend the combination of antidepressant and antipsychotic medications in the acute pharmacologic treatment of PD. However, little is known about the continuation treatment of PD. Of particular concern, it is not known whether antipsychotic medication needs to be continued once an episode of PD responds to pharmacotherapy. This issue has profound clinical importance. On the one hand, the unnecessary continuation of antipsychotic medication exposes a patient to adverse effects, such as weight gain and metabolic disturbance. On the other hand, premature discontinuation of antipsychotic medication has the potential risk of early relapse of a severe disorder.The primary goal of this multicenter randomized placebo-controlled trial is to assess the risks and benefits of continuing antipsychotic medication in persons with PD once the episode of depression has responded to treatment with an antidepressant and an antipsychotic. Secondary goals are to examine age and genetic polymorphisms as predictors or moderators of treatment variability, potentially leading to more personalized treatment of PD. Individuals aged 18-85 years with unipolar psychotic depression receive up to 12 weeks of open-label treatment with sertraline and olanzapine. Participants who achieve remission of psychosis and remission/near-remission of depressive symptoms continue with 8 weeks of open-label treatment to ensure stability of remission. Participants with stability of remission are then randomized to 36 weeks of double-blind treatment with either sertraline and olanzapine or sertraline and placebo. Relapse is the primary outcome. Metabolic changes are a secondary outcome.This trial will provide clinicians with much-needed evidence to guide the continuation and maintenance treatment of one of the most disabling and lethal of psychiatric disorders.

Project description:ObjectivesAdaptive platforms allow for the evaluation of multiple interventions at a lower cost and have been growing in popularity, especially during the COVID-19 pandemic. The objective of this review is to summarize published platform trials, examine specific methodological design features among these studies, and hopefully aid readers in the evaluation and interpretation of platform trial results.MethodsWe performed a systematic review of EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov from January 2015 to January 2022 for protocols or results of platform trials. Pairs of reviewers, working independently and in duplicate, collected data on trial characteristics of trial registrations, protocols, and publications of platform trials. We reported our results using total numbers and percentages, as well as medians with interquartile range (IQR) when appropriate.ResultsWe identified 15,277 unique search records and screened 14,403 titles and abstracts after duplicates were removed. We identified 98 unique randomized platform trials. Sixteen platform trials were sourced from a systematic review completed in 2019, which included platform trials reported prior to 2015. Most platform trials (n = 67, 68.3%) were registered between 2020 and 2022, coinciding with the COVID-19 pandemic. The included platform trials primarily recruited or plan to recruit patients from North America or Europe, with most subjects being recruited from the United States (n = 39, 39.7%) and the United Kingdom (n = 31, 31.6%). Bayesian methods were used in 28.6% (n = 28) of platform RCTs and frequentist methods in 66.3% (n = 65) of trials, including 1 (1%) that used methods from both paradigms. Out of the twenty-five trials with peer-reviewed publication of results, seven trials used Bayesian methods (28%), and of those, two (8%) used a predefined sample size calculation while the remainder used pre-specified probabilities of futility, harm, or benefit calculated at (pre-specified) intervals to inform decisions about stopping interventions or the entire trial. Seventeen (68%) peer-reviewed publications used frequentist methods. Out of the seven published Bayesian trials, seven (100%) reported thresholds for benefit. The threshold for benefit ranged from 80% to >99%.ConclusionWe identified and summarized key components of platform trials, including the basics of the methodological and statistical considerations. Ultimately, improving standardization and reporting in platform trials require an understanding of the current landscape. We provide the most updated and rigorous review of platform trials to date.

Dataset Information

Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology.

Publications

Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology.

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