Telemedicine-Based Therapy for Substance Abuse

Overseen By Linda Mobley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Acute psychosis, Cognitive deficits, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy and does not mention medication changes.

What data supports the effectiveness of the treatment MI-CBT Teletx for substance abuse?

Research shows that telemedicine, including computer-based cognitive-behavioral therapy (CBT), is effective in treating substance use disorders. Studies have found that CBT delivered through telemedicine can be as effective as traditional in-person therapy, helping people reduce their substance use. ^{1 2 3 4 5}

Is telemedicine-based therapy for substance abuse safe for humans?

Research on telemedicine-based therapies, including those for substance abuse, suggests they are generally safe for humans. Studies have shown that these digital programs are well-received by participants and do not negatively impact treatment outcomes, indicating their safety and acceptability. ^{3 4 5 6 7}

How is the MI-CBT Teletx treatment for substance abuse different from other treatments?

MI-CBT Teletx is unique because it uses telemedicine, specifically videoconferencing, to deliver therapy remotely, making it more accessible to people in areas with limited treatment options. This approach allows real-time communication between patients and clinicians, which can be especially beneficial for those in rural or underserved communities. ^{3 5 8 9 10}

Research Team

Allison Lin, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals who have used substances on average twice a week over the past month, have been outpatient at Michigan Medicine in the last year, and own a device like a smartphone with internet. People can't join if they can't consent (like having acute psychosis), had severe alcohol withdrawal before, or don't speak English.

Inclusion Criteria

You have been diagnosed with a substance use disorder according to the DSM-5, or you have been using substances on average two days per week for the past month.

I have received outpatient care at Michigan Medicine in the last year.

Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)

Exclusion Criteria

You cannot speak or understand English.

I am mentally capable of understanding and consenting to participate.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 8 psychosocial sessions delivered via telehealth, including motivational interviewing and cognitive behavioral therapy

8 weeks

Sessions delivered via phone or videoconference

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and assessments

4 weeks

Treatment Details

Interventions

• MI-CBT Teletx

Trial Overview The study tests motivational interviewing and psychosocial interventions delivered through telehealth to help patients with Substance Use Disorder (SUD). It aims to refine these programs for better feasibility and acceptability among 50 participants.

Participant Groups

Group I: Teletx Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

CBT4CBT, a computer-based cognitive-behavioral therapy, was found to be a safe and effective stand-alone treatment for individuals with substance use disorders, showing significant reductions in substance use compared to standard treatment after six months.

Participants using CBT4CBT reported higher satisfaction and better understanding of cognitive and behavioral concepts than those receiving traditional clinician-delivered CBT, which had a higher dropout rate and less effectiveness at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Kiluk, BD., Nich, C., Buck, MB., et al.[2019]

In a randomized clinical trial with 101 cocaine-dependent individuals on methadone, those who had access to computer-based cognitive-behavioral therapy (CBT4CBT) were significantly more likely to achieve 3 or more consecutive weeks of abstinence from cocaine (36% vs. 17%).

The study demonstrated that CBT4CBT not only improved immediate treatment outcomes but also showed durable effects, with continued improvement observed 6 months after treatment, highlighting its potential as an effective and easily disseminable adjunct to traditional addiction treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Carroll, KM., Kiluk, BD., Nich, C., et al.[2023]

A survey of 363 substance use disorder organizations in the U.S. revealed that 50% showed high interest in telemedicine applications, particularly in computerized screenings and telephone-based supports, indicating a strong potential for integrating technology in treatment.

There is a significant gap between interest and actual use of certain telemedicine tools, such as texting appointment reminders and mobile apps for recovery, suggesting opportunities for further development and implementation in substance use disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telemedicine in Addiction Treatment: Current Practices and Organizational Implementation Characteristics. Molfenter, T., Brown, R., O'Neill, A., et al.[2020]

A pilot study involving 127 rural alcohol users showed that participating in 3 or more sessions of motivational enhancement therapy via telemedicine significantly reduced the likelihood of any alcohol use by 72%.

While there were no overall differences between groups, those who engaged in more sessions reported fewer days of drinking, fewer drinks per week, and fewer days with alcohol-related problems, suggesting that telemedicine can effectively reach at-risk populations who may not seek traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

METelemedicine: a pilot study with rural alcohol users on community supervision. Staton-Tindall, M., Havens, JR., Webster, JM., et al.[2021]

Telemedicine, specifically through videoconferencing, is being used to effectively deliver motivational enhancement therapy to at-risk alcohol users in rural areas, where access to treatment is often limited.

This approach not only addresses the lack of evidence-based substance abuse treatment in rural communities but also tailors interventions to the specific needs of at-risk groups, enhancing the potential for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. Staton-Tindall, M., Wahler, E., Webster, JM., et al.[2021]

An 8-week all-virtual program for treating methamphetamine use disorder (MUD) was effective, with participants showing increased likelihood of testing negative for meth use over the course of the treatment (OR = 1.57).

The program, which included counseling, therapeutic tasks, and medical oversight, was well-received, with 55% of participants completing it and 16 out of 27 reporting no meth use one month after finishing the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demonstration of an app-delivered digital therapeutic program for methamphetamine use disorder. Muhlner, K., DeFlavio, J., Ang, A., et al.[2023]

A combination of motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT), and contingency management (CM) is effective for treating cannabis use disorders, and a computer-assisted version of this treatment shows promise in overcoming barriers to access.

In a 12-week study with 38 adults, both therapist-delivered and computer-delivered treatments resulted in similar attendance and cannabis use outcomes, indicating that computer-assisted therapy is a viable alternative that maintains treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. Budney, AJ., Fearer, S., Walker, DD., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

Use of Telemedicine in Addiction Treatment: Current Practices and Organizational Implementation Characteristics. [2020]

4. England pubmed.ncbi.nlm.nih.gov

METelemedicine: a pilot study with rural alcohol users on community supervision. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Demonstration of an app-delivered digital therapeutic program for methamphetamine use disorder. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Telemedicine in the treatment of addictions. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Telemedicine-delivered treatment for substance use disorder: A scoping review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Telemedicine-delivered treatment interventions for substance use disorders: A systematic review. [2020]