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OpenTrials
Active, Not Recruiting

NCT Number: NCT04768920

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance Dependence Substance Use Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MI-CBT Teletx

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)

Primary outcomes

  1. Feasibility of the intervention (engagement)

    Time frame: 8 weeks

    Percent (%) of participants engaging in the intervention

  2. 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

Other outcomes

  1. Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)

    Time frame: baseline, 8 weeks post-baseline

    Based on frequency and quantity, higher scores indicate worse outcome.

  2. Change in Alcohol Consumption

    Time frame: baseline, 8 weeks post baseline

    Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including binge drinking, with total consumption calculated.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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