Opioid-use DisorderD-TECTNCT04535583

Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder

An observational study of Opioid-use Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-use Disorder
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 23 Jul 2020to 21 Sep 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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).

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Northern California, Division of Research
Oakland, California, 94612

Other trials in United States

About this study

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.

Read the detailed description

This is an observational study designed to (1) evaluate the feasibility and utility of digital health technology in a Medication for Opioid Use Disorder (MOUD) treatment population, and (2) capitalize on the availability of Electronic Health Record (EHR) data to relate passive and active sensing data to treatment retention and medication adherence.

Eligible participants are identified through EHR records, sent an invitational letter through secure message, and then called to recruit and screen. Following verbal consent to screen, research staff will perform a screening assessment over the phone/video to determine preliminary study eligibility prior to scheduling the baseline phone/video appointments. Following electronic signed informed consent, participants will be asked to complete an interviewer administered Baseline assessment. In addition to the screening and baseline assessments, the participants will be asked to wear a smartwatch and carry a smartphone continuously for a period of 12 weeks. Smartphone and smartwatch data will be passively collected. In addition, participants will be prompted to respond to questions through a smartphone (i.e., Ecological Momentary Assessment (EMA)) 3 times daily for 12 weeks. In addition to the EMA prompts, individuals will be asked to self-initiate EMAs if substance use occurred.

After the 12-week active study phase, participants will be asked to complete a follow-up phone/video appointment.

EHR and medical claims data will be extracted 16 weeks after study completion (data will be collected 12 months prior to EMA start through 12 weeks after EMA start).

For those who consent to the optional social media component, social media data will be downloaded by the participant directly from the social media platform to a secure server using a remote desktop at the beginning of the study and at the end of the study.

Conditions: Opioid-use Disorder
Keywords: Opioid Use Disorder, Digital Health, Substance Use Disorder, Social Media
Medical subject headings: Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04535583
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Smartphone Sensor Data
The percentage of days carried the smartphone at least 8 hours per day.
Measured: 84 days (or 12-weeks)

Secondary outcomes (3)

Social Media Data
The percentage of participants who consented to download social media data.
Measured: At baseline
The Number of Ecological Momentary Assessments (EMA) With Response
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).
Measured: up to 3 times per day for 84 days (or 12-weeks)
Smartwatch Sensor Data
The percentage of days wore the smartwatch at least 18 hours per day.
Measured: 84 days (or 12-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 202021 Sep 2021

First posted2 Sep 2020
Study start23 Jul 2020
Primary completion12 Jun 2021
Study completion21 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04535583
Sponsor's protocol ID: CTN-0084-A2
Other IDs: UG1DA040309, UG1DA040314
Acronym: D-TECT
Status last verified: Nov 2023
First submitted: 3 Aug 2020
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A de-identified dataset will be made available by the Principal Investigators upon request.

Publications

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.
PubMed 35573377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder
ClinicalTrials.gov ID: NCT04535583
Acronym / sponsor ID: D-TECT / CTN-0084-A2
Conditions: Opioid-use Disorder
Keywords: Opioid Use Disorder, Digital Health, Substance Use Disorder, Social Media
Study type: Observational
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: National Drug Abuse Treatment Clinical Trials Network, Dartmouth College, Kaiser Permanente, National Institute on Drug Abuse (NIDA)
Study start: 23 Jul 2020 (actual)
Primary completion: 12 Jun 2021 (actual)
Study completion: 21 Sep 2021 (actual)
First posted: 2 Sep 2020 (actual)
Results: Posted 15 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

After the 12-week active study phase, participants will be asked to complete a follow-up phone/video appointment.

EHR and medical claims data will be extracted 16 weeks after study completion (data will be collected 12 months prior to EMA start through 12 weeks after EMA start).

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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);

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Smartphone Sensor Data
Time frame: 84 days (or 12-weeks)
The percentage of days carried the smartphone at least 8 hours per day.

3 secondary outcomes

Social Media Data
Time frame: At baseline
The Number of Ecological Momentary Assessments (EMA) With Response
Time frame: up to 3 times per day for 84 days (or 12-weeks)
Smartwatch Sensor Data
Time frame: 84 days (or 12-weeks)

Results and safety

Results posted to the registry on 15 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EMA Plus Passive Sensing (Social Media Optional)	65	62

Primary outcome: Smartphone Sensor Data

Time frame: 84 days (or 12-weeks). Mean (95% Confidence Interval). Unit: mean percentage of days

Measure	EMA Plus Passive Sensing (Social Media Optional) n = 62
Value	94.2 (90.8 to 97.6)

Population analysed: 62 out of the 65 participants completed the baseline visit and received the study smartphone or had the study app setup on their personal smartphone to contribute passive data via smartphone.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EMA Plus Passive Sensing (Social Media Optional)	0 of 65 (0%)	5 of 65 (7.7%)	1 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35573377Marsch 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.
Individual participant dataSharing planned: Yes. A de-identified dataset will be made available by the Principal Investigators upon request.

Related trials for Opioid-use Disorder

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
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Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa A Marsch, PhD principal investigator

Dartmouth College

Cynthia Campbell, PhD principal investigator

Kaiser Permanente

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-use Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smartphone Sensor Data (time frame: 84 days (or 12-weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.