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

Trial Summary

What is the purpose of this trial?

This trial uses telehealth in emergency rooms to start addiction medication and connect patients to further care. It targets adults with opioid addiction in rural Georgia, where specialized treatment is scarce. The process involves video consultations with experts and support from recovery coaches.

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 data supports the effectiveness of the treatment Sociobehavioral Intervention, Behavioral Therapy, Psychosocial Intervention for opioid addiction?

Research shows that combining psychosocial interventions with opioid agonist therapy (OAT) can be beneficial for people with opioid use disorder (OUD). These interventions, which include motivational and cognitive/behavioral techniques, are tailored to individual needs and have been adapted from proven psychological therapies to help those who do not fully respond to OAT. ^{1 2 3 4 5}

Is the Telehealth Sociobehavioral Intervention for Opioid Addiction safe for humans?

Research on psychosocial interventions, which are similar to the Telehealth Sociobehavioral Intervention, suggests they are generally safe for humans. These interventions have been used alongside opioid treatments without significant safety concerns. ^{1 2 3 6 7}

How is the Telehealth Sociobehavioral Intervention for Opioid Addiction different from other treatments?

This treatment is unique because it uses telehealth to deliver behavioral therapy and psychosocial support remotely, which can help overcome logistical and financial barriers that often prevent people from accessing in-person counseling. This approach allows for more flexible and continuous engagement, potentially improving retention and outcomes for individuals with opioid addiction. ^{4 8 9 10 11}

Research Team

Emily Kiernan, DO

Principal Investigator

Emory University

Eligibility Criteria

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

I am 18 years old or older.

English speaking

Clinically sober

Exclusion Criteria

I am under the age of 18.

Already receiving MAT or psychotherapy for OUD prior to ED arrival

Prior participation in the study

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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 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]

References

1. United States 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. [2021]

2. United States 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Perceived need and availability of psychosocial interventions across buprenorphine prescriber specialties. [2022]

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

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. [2022]

5. England 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. [2022]

6. Ireland 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Behavior therapy for depression in drug dependence (BTDD): results of a stage Ia therapy development pilot. [2013]

8. United States 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. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Outcomes for patients receiving telemedicine-delivered medication-based treatment for Opioid Use Disorder: A retrospective chart review. [2022]

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

Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. [2022]

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

When a pandemic and epidemic collide: Lessons learned about how system barriers can interrupt implementation of addiction research. [2023]