NCT06341608

Brief Summary

The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies. The specific aims are to: 1) identify components of an effective telehealth intervention and barriers to implementation, 2) partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine, and 3) conduct a pilot trial of the telehealth intervention for OUD treatment. The investigators will enroll 60 patients, 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine, with a treatment episode duration of 1-3 months, and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician, to receive the telehealth for OUD care delivery intervention. The investigators will measure clinical, implementation, and patient satisfaction outcomes.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

March 11, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 11, 2024

Last Update Submit

March 5, 2026

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Treatment Engagement

    Enrolled in care; attended scheduled follow up visits or has rescheduled missed visits with care team; has filled, active buprenorphine prescription (from self-report and EHR)

    14,30, 90 days

Secondary Outcomes (6)

  • Days of medication for OUD

    14, 30, 90 days

  • Opioid and non-opioid substance use

    Substance use in past 7 days, measured at 14, 30, 90 days

  • Feasibility of intervention

    30 and 90 days

  • Acceptability

    30 and 90 days

  • Fidelity

    14 days

  • +1 more secondary outcomes

Study Arms (1)

Patients with OUD, eligible for treatment with buprenorphine

EXPERIMENTAL
Behavioral: Telehealth for opioid use disorder treatment delivery

Interventions

Telehealth for opioid use disorder treatment deliveryBEHAVIORAL

A multi-component patient and provider facing strategy to be designed in Aim 2. Components will likely include 1) a user-friendly telehealth platform for performing all medication induction and maintenance visits, 2) integrated case management, 3) text message scheduling reminders, 4) mailed saliva drug screening tests

Patients with OUD, eligible for treatment with buprenorphine

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll genders are eligible
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients:
  • Must be 18 years old or older
  • Clinical diagnosis of opioid use disorder and/or mental health diagnosis
  • Must be receiving treatment for opioid use disorder and/or mental health diagnosis at an outpatient community-based substance use disorder and/or mental health treatment program
  • Must speak English
  • For providers and staff:
  • Must be 18 years old or older
  • Must be in a provider, clinical staff, or leadership role caring for patients with substance use disorders and/or mental health diagnoses
  • Must speak English
  • Aim 2b:
  • Must be 18 years or older
  • Clinical diagnosis of opioid use disorder
  • Must be receiving treatment for OUD with buprenorphine at Prevention Point Philadelphia
  • Must speak English
  • Aim 3:
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Shoshana Aronowitz, PhD

CONTACT

781-266-8571visho@nursing.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

April 2, 2024

Study Start

April 15, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

US(1)