Safety of Oral Amphetamine Administered during Positron Emission Tomography Scans in Medically Screened Humans

Weidner, Lora D.; Paris, A.; Frankle, W. Gordon; Narendran, Rajesh

doi:10.1371/journal.pone.0140647

Cited by 1 publication

(2 citation statements)

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“…The study included the amphetamine challenge in both presence (period 2) and absence (period 1) of the experimental study drug. Using wearable device data, we observed an increase of HR following the amphetamine challenge similar in magnitude, as described earlier . Additionally, we observed markedly increased HR when study subjects were ambulatory and physically active, as detected by both BodyGuardian and Actiwatch accelerometers.…”

Section: Resultssupporting

confidence: 84%

“…The small study size requires confirmation of these findings in a larger clinical trial. We used the amphetamine administration component of the study as a model setting to demonstrate the utility of continuous VS monitoring using previously published results . However, detecting unanticipated safety signals represents a significantly greater challenge, as it will require more careful examination of the findings to rule out potential artifacts.…”

Section: Discussionmentioning

confidence: 99%

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Continuous Monitoring Using a Wearable Device Detects Activity‐Induced Heart Rate Changes After Administration of Amphetamine

Izmailova

McLean

Hather

et al. 2019

Clinical Translational Sci

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Wearable digital devices offer potential advantages over traditional methods for the collection of health-related information, including continuous collection of dense data while study subjects are ambulatory or in remote settings. We assessed the utility of collecting continuous actigraphy and cardiac monitoring by deploying two US Food and Drug Administration (FDA) 510(k)-cleared devices in a phase I clinical trial of a novel compound, which included the use of an amphetamine challenge. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep. The Preventice BodyGuardian (BodyGuardian) was used for monitoring heart rate (HR) and respiratory rate (RR), via single-lead electrocardiogram (ECG) recordings, together with physical activity. We measured data collection rates, compared device readouts with conventional measures, and monitored changes in HR measures during the amphetamine challenge. Completeness of data collection was good for the Actiwatch (96%) and lower for the BodyGuardian (80%). A good correlation was observed between device and in-clinic measures for HR (r = 0.99; P < 0.001), but was poor for RR (r = 0.39; P = 0.004). Manual reviews of selected ECG strips corresponding to HR measures below, within, and above the normal range were consistent with BodyGuardian measurements. The BodyGuardian device detected clear HR responses after amphetamine administration while subjects were physically active, whereas conventional measures collected at predefined timepoints while subjects were resting and supine did not. Wearable digital technology shows promise for monitoring human subjects for physiologic changes and pharmacologic responses, although fit-for-purpose evaluation and validation continues to be important prior to the wider deployment of these devices.Wearable digital technologies have been the subject of strong commercial promotion in recent years and have been adopted by many consumers. Although several devices have been approved by regulatory agencies and are increasingly used in healthcare settings, wearable devices have yet to find widespread application in industry-sponsored drug development studies.Despite significant progress, 1-3 there are few published studies that include critical analysis of the technology at

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Section: Resultssupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%