Towards Detecting Cocaine Use Using Smartwatches in the NIDA Clinical Trials Network

NCT02915341 | Completed DMC

• 1 other identifier: CTN-0073-Ot
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to extend previous work in the development of methods to automatically detect the timing of cocaine use from cardiac interbeat interval and physical activity data derived from wearable, unobtrusive mobile sensor technologies. The specific objectives of this protocol are to characterize under which conditions high quality continuous interbeat interval data and physical activity data can be obtained from a specially developed smartwatch device in the natural field setting among a population of cocaine users. In addition to identifying common failure scenarios and understanding wearability/usage patterns when collecting interbeat interval from smartwatches, this study will extend previous work in the detection of cocaine use via interbeat interval and physical activity data that were previously obtained from wearable chestband sensors. Information from this study will contribute toward the adaptation of the investigators' existing computational model for detecting cocaine use via the chest sensors, so it can be applied to the interbeat and physical activity data obtained from less obtrusive smartwatches.

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Ambulatory physiological and activity data

  Data yield of ambulatory physiological and activity data will be used to characterize the feasibility of using smartwatches to collect reliable interbeat interval and physical activity data in the natural field setting, sensor usage patterns (e.g., hours per day of device wear, periods of device removal), and common failure scenarios (e.g., poor sensor data quality, missing data due to removal of the device, or other factors which may affect data yield). Ambulatory physiological and activity data will be collected using passive mobile sensor data collection platforms (AutoSense chest sensors and smartwatches). This data is collected via AutoSense sensors and will utilize participants' heart beats, which will be continually streamed into the database at the Mobile Sensor Data-to-Knowledge Center of Excellence (University of Memphis). This is one assessment with one unit of measurement (heart rate) that will inform the multiple aspects of this outcome.

  14 days

• Device wearability

  Device wearability (e.g., acceptability and burden) will be characterized via user questionnaires.

  14 days

• Cocaine use

  Real-time self-report of cocaine use via Ecological Momentary Assessment (EMA) questionnaire prompts via the smartphone device, retrospective recall of drug use via Timeline Followback (TLFB), and urine drug assay for cocaine and other drugs of abuse will be used to adapt the computational model, so that it can be applied to the interbeat and physical activity data obtained from smartwatches. These measurements of cocaine use will be aggregated to arrive at one reported value (cocaine use episodes) to inform the model.

  14 days

Secondary Outcomes (2)

• Device comparison

  Through study completion, an average of 18 months

• Cocaine detection specificity

  Through study completion, an average of 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The proposed study will be conducted with 25 cocaine users from the parent clinical trial who agree to wear the AutoSense smartwatches and chestband for two weeks. Participants in the parent clinical trial are unemployed, cocaine-using adults who inject drugs and are enrolled in opioid agonist treatment. There are no study groups or randomization.

You may qualify if:

• Be enrolled in the parent clinical trial for at least one week.
• Be active in the Induction Period (days 8-35) of the parent clinical trial at the time of study intake.
• Provide a cocaine-positive urine sample in the week prior (based on thrice-weekly urine samples collected as a part of the parent trial).
• Be available for the duration of the study (16 days total) and able to attend weekday research check-in sessions at the recruitment site.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Drug Abuse Treatment Clinical Trials Network: collaborator
• University of Memphis: collaborator
• Johns Hopkins University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Dartmouth College: collaborator

Study Sites (1)

Center for Learning and Health, Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Hossain SM, Ali AA, Rahman M, Ertin E, Epstein D, Kennedy A, Preston K, Umbricht A, Chen Y, Kumar S. Identifying Drug (Cocaine) Intake Events from Acute Physiological Response in the Presence of Free-living Physical Activity. IPSN. 2014;2014:71-82.

  PMID: 25531010 BACKGROUND

• Ertin, E., Stohs, N., Kumar, S., Raij, A.B., al'Absi, M., Kwon, T., Mitra, S., Shah, S., & Jeong, J.W. (2011). AutoSense: Unobtrusively wearable sensor suite for inferencing of onset, causality, and consequences of stress in the field: Proceedings of the 9th ACM Conference on Embedded Networked Sensor Systems (SenSys) (pp. 274-287). New York, NY: Association for Computing Machinery.

  BACKGROUND

• Ertin E, Sugavanam N, Holtyn AF, Preston KL, Bertz JW, Marsch LA, McLeman B, Shmueli-Blumberg D, Collins J, King JS, McCormack J, Ghitza UE. An Examination of the Feasibility of Detecting Cocaine Use Using Smartwatches. Front Psychiatry. 2021 Jun 24;12:674691. doi: 10.3389/fpsyt.2021.674691. eCollection 2021.

  PMID: 34248712 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa A. Marsch, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Santosh Kumar, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 27, 2016
• Study Start: May 1, 2016
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)