NCT04535583: D-TECT

Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder

Completed Results posted Last updated 15 November 2023

What this trial tests

trial in Opioid-use Disorder in 65 participants. Completed in 21 September 2021.

Timeline

23 July 2020

Primary endpoint
12 June 2021

21 September 2021

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	65
Start date	23 July 2020
Primary completion	12 June 2021
Estimated completion	21 September 2021
Sites	1 location across United States

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Smartphone Sensor Data Primary · 84 days (or 12-weeks)

The percentage of days carried the smartphone at least 8 hours per day.

Group	Value	95% CI
EMA Plus Passive Sensing (Social Media Optional)	94.2	90.8 – 97.6

Social Media Data Secondary · At baseline

The percentage of participants who consented to download social media data.

Group	Value	95% CI
EMA Plus Passive Sensing (Social Media Optional)	49

The Number of Ecological Momentary Assessments (EMA) With Response Secondary · up to 3 times per day for 84 days (or 12-weeks)

The response rate to Ecological Momentary Assessment prompts during the 12-week study phase. The EMA Response Rate for each participant is the number of EMAs responded to over the last 83 days of the study (up to 249 responses \[83 days X 3 EMA\]) (yields a percentage). The total mean EMA response rate was based on the EMA response rate (percentage) across all participants in the study (N=62).

Group	Value	95% CI
EMA Plus Passive Sensing (Social Media Optional)	70.0	63.5 – 81.4

Smartwatch Sensor Data Secondary · 84 days (or 12-weeks)

The percentage of days wore the smartwatch at least 18 hours per day.

Group	Value	95% CI
EMA Plus Passive Sensing (Social Media Optional)	73.7	67.7 – 79.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 11 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

EMA Plus Passive Sensing (Social Media Optional)

Serious: 0/65 (0%)

Deaths: 1/65

Other adverse events (2 terms — click to expand)

Reaction	System	EMA Plus Passive Sensing (…
Rash	Skin and subcutaneous tissue disorders	—
Suicidal Ideation	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT04535583 adverse events section.

Sponsor's own description

The main objective of the study is to evaluate the feasibility of utilizing digital health technology with opioid use disorder (OUD) patients as measured by a 12-week period of continuous assessment using smartphone surveys and digital sensing. In addition, we will examine the utility of 3 types of digital data (Ecological Momentary Assessment (EMA); Digital sensing; and social media data) in predicting OUD treatment retention and buprenorphine medication adherence.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Feasibility and Utility of Harnessing Digital Health to Understand Clinical Trajectories in Medication Treatment for Opioid Use Disorder: D-TECT Study Design and Methodological Considerations.
   Marsch LA, Chen CH, Adams SR, Asyyed A, et al · · 2022 · cited 8× · PMID 35573377 · DOI 10.3389/fpsyt.2022.871916