Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder

NCT04535583 | Completed Results

• 3 other identifiers: CTN-0084-A2UG1DA040309UG1DA040314
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid-use Disorder

Keywords

Opioid Use Disorder; Digital Health; Substance Use Disorder; Social Media

Outcome Measures

Primary Outcomes (1)

• Smartphone Sensor Data

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

  84 days (or 12-weeks)

Secondary Outcomes (3)

• Social Media Data

  At baseline

• The Number of Ecological Momentary Assessments (EMA) With Response

  up to 3 times per day for 84 days (or 12-weeks)

• Smartwatch Sensor Data

  84 days (or 12-weeks)

Study Arms (1)

EMA plus passive sensing

Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is recruiting individual who are active in medication treatment for opioid use disorder (MOUD) with buprenorphine for at least 2 weeks.

You may qualify if:

• Have been active in Kaiser outpatient buprenorphine treatment for OUD for the past 2 weeks (determined at screening);
• Be ≥18 years old (determined at screening);
• Be able to understand English (determined at screening);
• Be available to participate in the full duration of the study (12 weeks) (determined at screening);
• Have an active email account and willing to provide the email address to researchers (determined at screening);
• Permit researchers to access personal electronic health record (EHR) and medical claims data (determined at screening);
• Be willing to carry and use personal or study provided smartphone for 12 weeks (determined at screening); and
• Be willing to wear a smartwatch continuously (except during pre-defined activities such as showering) for 12 weeks (determined at screening).

You may not qualify if:

• Are unwilling or unable to provide informed consent (determined during the Consent process and during Consent Quiz); and
• Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities (determined by Prisoner Status Assessment at each study visit).

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Drug Abuse Treatment Clinical Trials Network: collaborator
• Dartmouth College: collaborator
• Kaiser Permanente: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Northern California, Division of Research

Oakland, California, 94612, United States

Location

Related Publications (1)

• Marsch LA, Chen CH, Adams SR, Asyyed A, Does MB, Hassanpour S, Hichborn E, Jackson-Morris M, Jacobson NC, Jones HK, Kotz D, Lambert-Harris CA, Li Z, McLeman B, Mishra V, Stanger C, Subramaniam G, Wu W, Campbell CI. 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. Front Psychiatry. 2022 Apr 29;13:871916. doi: 10.3389/fpsyt.2022.871916. eCollection 2022.

  PMID: 35573377 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Lisa A. Marsch
• Organization: Geisel School of Medicine at Dartmouth

lisa.a.marsch@dartmouth.edu

603-646-7092

Study Officials

• Lisa A Marsch, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Cynthia Campbell, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: September 2, 2020
• Study Start: July 23, 2020
• Primary Completion: June 12, 2021
• Study Completion: September 21, 2021
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the completion of the study and data lock.
• Access Criteria: Prior to receiving any study data, researchers/institutions will need to enter into a data sharing agreement with the institution(s) providing the de-identified study data.

Locations

US (1)