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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04768920
• Other study ID #: HUM00189259
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Dependence
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)	Based on frequency and quantity, higher scores indicate worse outcome.	baseline, 8 weeks post-baseline
Other	Change in Alcohol Consumption	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.	baseline, 8 weeks post baseline
Primary	Feasibility of the intervention (engagement)	Percent (%) of participants engaging in the intervention	8 weeks
Primary	Tele-Tx Intervention acceptability	Study-specific acceptability rating completed by participants. Based on Likert scale, higher scores indicate greater treatment acceptability	8 weeks