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Clinical Trials/NCT04768920
NCT04768920
Active, not recruiting
Not Applicable

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

University of Michigan1 site in 1 country50 target enrollmentNovember 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
University of Michigan
Enrollment
50
Locations
1
Primary Endpoint
Tele-Tx Intervention acceptability
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2022
End Date
February 28, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allison Lin

Assistant Professor of Psychiatry

University of Michigan

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Tele-Tx Intervention acceptability

Time Frame: 8 weeks

Study-specific acceptability rating completed by participants. Based on Likert scale, higher scores indicate greater treatment acceptability

Feasibility of the intervention (engagement)

Time Frame: 8 weeks

Percent (%) of participants engaging in the intervention

Study Sites (1)

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