Telehealth Sociobehavioral Intervention for Opioid Addiction

(REAL TTIME Trial)

Overseen By Emily Kiernan, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: MAT, Psychotherapy, Prior participation, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to make opioid use disorder (OUD) treatment more accessible in rural Georgia by using telehealth strategies in emergency departments (EDs). It tests a new sociobehavioral program, a type of behavioral therapy, that combines telemedicine and peer recovery coaches to connect patients to medication-assisted treatment (MOUD). The trial compares this approach to standard care by collecting data before and after the intervention at different rural EDs. English-speaking individuals who are clinically sober and medically stable might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for OUD treatment in rural communities.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are already receiving medication-assisted treatment (MAT) for opioid use disorder, you would not be eligible to participate.

What prior data suggests that this sociobehavioral intervention is safe for opioid addiction treatment?

Research has shown that programs like the one in this trial are usually easy for people to handle. Some studies suggest these programs can help individuals stay on track with their opioid use disorder (OUD) treatment and reduce opioid use over time. This type of treatment carries little risk of harmful side effects and often aids in recovery. The program in this trial aims to make medication-assisted treatment more accessible through telehealth, a safe and common method for supporting people with OUD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a fresh approach to tackling opioid addiction, particularly in rural areas. Unlike standard treatments like medication-assisted therapy, this intervention uses a sociobehavioral program delivered via telemedicine. This method expands access to vital medications for opioid use disorder (MOUD) through emergency department-based telemedicine strategies, making it more accessible for those in remote locations. Additionally, the trial includes a unique component of poison center consultations and peer recovery coaches, providing a comprehensive support system that current options might lack.

What evidence suggests that this sociobehavioral intervention is effective for opioid addiction?

Research shows that telehealth and social support can aid in treating opioid addiction. In this trial, participants in the Sociobehavioral program Group will engage in a novel sociobehavioral collaborative program. This program aims to improve health by expanding access to medication for opioid use disorder (MOUD) through an emergency department-based telemedicine strategy. Studies have found that telemedicine, which involves receiving medical help over the phone or internet, connects patients to treatment more effectively. One study found that online support programs help patients remain in treatment longer, which is crucial for recovery. Another study suggests that combining counseling with medication for opioid addiction increases the chances of success. These methods aim to make treatment more accessible, especially in rural areas where it can be hard to find. Overall, these strategies seem promising in supporting people with opioid addiction on their path to recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Emily Kiernan, DO

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults over 18 in rural Georgia who speak English and are medically stable, but struggling with opioid use disorder. They should not be currently receiving medication-assisted treatment or psychotherapy for OUD, nor have participated in this study before.

Inclusion Criteria

English speaking

Clinically sober

Medically and psychiatrically stable

Exclusion Criteria

Already receiving MAT or psychotherapy for OUD prior to ED arrival

Prior participation in the study

If their clinical condition worsens such that continued participation would be considered unsafe in the opinion of the PRC or ED staff

Timeline for a Trial Participant

Planning

Aggregate data obtained to determine existing practices for treating OUD and opioid withdrawal in rural EDs

Varies by site

Implementation

Prospective study of poison center OUD consultation and PRC intervention, collecting participant-level data

Stepped-wedge rollout

Follow-up

Participants are monitored for engagement with outpatient programs and maintenance on MOUD

30 days

1 visit (virtual)

Long-term Follow-up

Monitoring of changes in patient outcomes related to MOUD and RCO linkage

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Sociobehavioral Intervention

Trial Overview The trial tests a new way to help people with opioid addiction by using telehealth in emergency departments. It involves medical toxicologists and peer recovery coaches working together to start treatment and connect patients to ongoing care.

How Is the Trial Designed?

Group I: Sociobehavioral program Group Experimental Treatment 1 Intervention

A novel sociobehavioral collaborative program that will improve the health of individuals in rural areas by expanding access to MOUD through an ED- based telemedicine strategy. Researchers will prospectively study a poison center OUD consultation and peer recovery coach (PRC) intervention as it is rolled out at each site, collecting participant-level data at baseline, one week post intervention and 30 days post intervention.

Group II: Control Group Active Control 1 Intervention

Patients who are seen at a participating hospital prior to the initiation of the intervention will be considered controls.

Sociobehavioral Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral Therapy for:

• Substance Use Disorders
• Mental Health Conditions

Approved in European Union as Psychosocial Intervention for:

• Substance Use Disorders
• Mental Health Conditions

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

The Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T) showed a moderate effect on improving treatment retention for opioid-dependent adults, particularly when the concerned significant other was a parent, where it had a significant impact (p<0.01).

CRAFT-T also significantly reduced opioid and other drug use among participants, indicating its potential efficacy as a treatment intervention for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Brigham, GS., Slesnick, N., Winhusen, TM., et al.[2021]

The study evaluated the MySafeRx mobile app, which combines remote motivational recovery coaching with supervised dosing via videoconference, aiming to improve medication adherence in patients undergoing buprenorphine treatment for opioid use disorder (OUD).

Implementation of the telehealth intervention faced significant challenges, including institutional barriers, staff burnout, and rigid protocols, highlighting the need for adaptable solutions in addiction treatment as telehealth becomes increasingly important in addressing the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When a pandemic and epidemic collide: Lessons learned about how system barriers can interrupt implementation of addiction research. Sharp, A., Carlson, M., Vroom, EB., et al.[2023]

A systematic review of 72 randomized controlled trials involving 5,404 participants found that adding psychosocial interventions, particularly rewards-based strategies like contingency management, significantly improved treatment retention for individuals receiving opioid agonist therapy (OAT) compared to OAT alone.

However, when it came to reducing opioid use or achieving abstinence, there were few significant differences between OAT plus psychosocial interventions and OAT-only, indicating that while psychosocial support can enhance retention, its impact on actual opioid use may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating comparative effectiveness of psychosocial interventions adjunctive to opioid agonist therapy for opioid use disorder: A systematic review with network meta-analyses. Rice, D., Corace, K., Wolfe, D., et al.[2021]

The MBC2OTP Project aims to implement Measurement-based Care (MBC) in opioid treatment programs to improve patient engagement and retention, using a two-phase pilot study involving qualitative and quantitative data collection from 32-48 staff interviews and 64-80 surveys across eight programs.

The study will evaluate the effectiveness of MBC by analyzing patient outcomes, such as opioid abstinence and treatment engagement, through chart reviews of 160 patient records before and after MBC integration, highlighting its potential to enhance treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. Scott, K., Guigayoma, J., Palinkas, LA., et al.[2022]

A personalized psychosocial intervention (PSI) is being tested in a clinical trial with 368 adults over 18 weeks to see if it can improve outcomes for patients with opioid use disorder who are not responding well to standard opioid agonist therapy (OAT).

The primary goal of the trial is to measure the effectiveness of PSI in achieving self-reported abstinence from heroin and cocaine, which will help tailor future treatments for individuals struggling with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial. Marsden, J., Stillwell, G., Hellier, J., et al.[2022]

A survey of 1174 physicians prescribing buprenorphine revealed that 93.3% believe patients would benefit from formal counseling during treatment, highlighting the perceived importance of psychosocial interventions.

However, only 36.4% of prescribers feel there are enough counselors available in their communities, with significant disparities in resource availability between addiction specialists and primary care providers, indicating a need for improved access to psychosocial support for patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived need and availability of psychosocial interventions across buprenorphine prescriber specialties. Lin, LA., Lofwall, MR., Walsh, SL., et al.[2022]

The COVID-19 pandemic has led to an increased use of telehealth for treating opioid use disorder (OUD), creating opportunities to study how different care methods impact patient outcomes.

Key questions about the quality of care for OUD, such as the necessity of physical exams and the effectiveness of telehealth check-ins versus in-person visits, need to be addressed to ensure patients receive effective and patient-centered treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and supporting high-quality telehealth for patients with opioid use disorder: The promise and potential pitfalls of telehealth expansion. Frank, CJ., Lin, LA.[2023]

A study of Veterans with opioid use disorder found that using telehealth for counseling significantly reduced the likelihood of discontinuing buprenorphine treatment compared to traditional in-person visits, with a hazard ratio of 0.69 for both substance use and mental health services.

Patients who exclusively used telehealth had an even lower risk of treatment discontinuation (hazard ratios of 0.48 for substance use and 0.46 for mental health), suggesting that telehealth can effectively support ongoing engagement in treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. Vakkalanka, JP., Lund, BC., Ward, MM., et al.[2022]

The study involved interviews with 14 individuals undergoing intensive outpatient treatment (IOT) for opioid use disorder (OUD), revealing that the process of connecting and disconnecting is crucial to their recovery experience.

Participants emphasized the importance of building connections with the IOT program, fellow patients, and staff, suggesting that fostering these relationships can significantly enhance engagement and support successful recovery from OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. Keen, A., Lu, Y., Draucker, CB.[2022]

In a trial with 29 participants, the Behavioral Therapy for Depression in Drug Dependence (BTDD) led to a 48% reduction in depression scores for those who responded to treatment after 16 sessions.

Participants who responded to BTDD were more active in behavioral activities and attended more sessions, suggesting that increasing engagement may enhance treatment outcomes, although there were no significant changes in opiate and cocaine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for depression in drug dependence (BTDD): results of a stage Ia therapy development pilot. Carpenter, KM., Aharonovich, E., Smith, JL., et al.[2013]

A retrospective chart review of 472 patients treated via telemedicine for opioid use disorder (OUD) from August 2015 to April 2019 showed that prescribing medications like buprenorphine and naltrexone is effective in a rural setting.

The study found that retention rates and toxicology results for patients receiving telemedicine treatment were comparable to those receiving traditional face-to-face treatment, suggesting that telemedicine can be a viable option for OUD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes for patients receiving telemedicine-delivered medication-based treatment for Opioid Use Disorder: A retrospective chart review. Weintraub, E., Greenblatt, AD., Chang, J., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-opioid-related-disorders-1-2023-cfb47

Telehealth Sociobehavioral Intervention for Opioid Addiction This trial uses telehealth in emergency rooms to start addiction medication and connect patients to further care. It targets adults with opioid addiction in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12274054/

Digital Psychosocial Interventions Tailored for People in ... A total of 60% of patients with opioid use disorder (OUD) leave treatment early. Psychosocial interventions can enhance treatment retention ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7861202/

Outcomes for patients receiving telemedicine-delivered ... We examined several demographic and substance use variables for individuals who consented to telemedicine treatment, retention in treatment over time, and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547222000563

Psychosocial and behavioral therapy in conjunction with ... Most patients received little or no OUD-related psychosocial and behavioral therapy after initiating buprenorphine treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05711056?tab=history&a=6

Record History | ver. 6: 2025-10-16 | NCT05711056 This sociobehavioral intervention will utilize two primary evidence-based strategies: delivering OUD consultation via telemedicine, which has been demonstrated ...

6. samhsa.gov samhsa.gov/libraries/evidence-based-practices-resource-center

Evidence-Based Practices Resource Center This resource provides information to primary care providers and practices on how to implement opioid use disorder treatment using buprenorphine. ... Opioid ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175946/

Pharmacological and Behavioral Treatment of Opioid Use ... The gold standard is medication‐assisted treatment (MAT), wherein pharmacotherapy is combined with some form of counseling or behavioral therapy.

8. journals.uchicago.edu journals.uchicago.edu/doi/full/10.1086/708369

Psychosocial Interventions in Office-Based Opioid Treatment MAT combined with behavioral health interventions has been shown to be more effective than behavioral intervention alone in reducing opioid use (Korthuis et al.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4795974/

A Systematic Review on the Use of Psychosocial ... Although both groups showed statistically significant improvements on 16 outcomes, there were no significant between-group differences for the 20 outcomes ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547219304970

Psychosocial intervention utilization and substance abuse ... Some studies suggested that the addition of psychosocial interventions may improve OUD treatment retention and opioid use at follow-up (Dugosh et al., 2016).