Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)

NCT ID: NCT04768920

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2026-02-28

Brief Summary

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The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future.

In addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.

Detailed Description

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Conditions

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Substance Use Disorders Substance Use Substance Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teletx

The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc).

Group Type EXPERIMENTAL

MI-CBT Teletx

Intervention Type BEHAVIORAL

Participants will first receive a 20-45 min phone or video session focused on raising participants' motivation to engage in treatment activities and psychoeducation material about substance use (i.e. "engagement session") including possible discussion about risks of substance use, value of alternative healthier activities, and the community and crisis resources pamphlet. The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc)

Interventions

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MI-CBT Teletx

Participants will first receive a 20-45 min phone or video session focused on raising participants' motivation to engage in treatment activities and psychoeducation material about substance use (i.e. "engagement session") including possible discussion about risks of substance use, value of alternative healthier activities, and the community and crisis resources pamphlet. The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Outpatient care at Michigan Medicine in past year
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
* Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)

Exclusion Criteria

* Inability to speak or understand English
* Conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
* Prior alcohol withdrawal seizures or delirium tremens (DTs). Those who are at-risk of complicated withdrawal (e.g., seizures, DTs) require greater medical attention and will be excluded and referred to their clinician for medical management.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Allison Lin

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00189259

Identifier Type: -

Identifier Source: org_study_id

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