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.
Is the treatment Sociobehavioral Intervention a promising treatment for opioid addiction?Yes, Sociobehavioral Intervention, delivered through telehealth, is promising for opioid addiction. It helps people stay in treatment longer and can be as effective as in-person visits. Telehealth makes it easier for people to access care, especially in rural areas, and supports medication management and recovery coaching.6781011
What safety data exists for telehealth sociobehavioral interventions for opioid addiction?The provided research does not directly address safety data for telehealth sociobehavioral interventions specifically. However, it discusses various psychosocial interventions, which are similar in nature. These studies focus on the effectiveness and implementation of psychosocial interventions as adjuncts to opioid agonist therapy, but they do not explicitly mention safety outcomes. Therefore, while these interventions are generally considered safe as part of comprehensive treatment plans, specific safety data for telehealth versions may not be available in the provided research.12345
What data supports the idea that Telehealth Sociobehavioral Intervention for Opioid Addiction is an effective treatment?The available research shows that psychosocial interventions, like Telehealth Sociobehavioral Intervention, are often recommended alongside medication treatments for opioid addiction. These interventions can help improve patient engagement and retention in treatment programs. For example, one study highlights that psychosocial interventions are needed to enhance patient engagement and retention in medication treatment within opioid treatment programs. This suggests that such interventions can be effective in supporting individuals with opioid addiction, especially when used alongside other treatments.34589
Do I have to stop taking my current medications for this trial?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) or psychotherapy for opioid use disorder (OUD), you cannot participate in the trial.
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Sociobehavioral program GroupExperimental Treatment1 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 GroupActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Georgia Poison CenterAtlanta, GA
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Who is running the clinical trial?
Emory UniversityLead Sponsor
References
Behavior therapy for depression in drug dependence (BTDD): results of a stage Ia therapy development pilot. [2013]Limited access to positive reinforcers is a central feature in behavioral formulations of substance use and depression, and evidence suggests both disorders share similar environmental contexts. The Behavioral Therapy for Depression in Drug Dependence (BTDD) was developed to target the density of potential reinforcers in a patient's environment to reduce both depression and illicit substance use using therapeutic techniques from three operant based treatment programs, Community Reinforcement Approach, Changing Reinforcement Events, and Treatment-plan Contingency Management. Results of an uncontrolled Stage Ia trial (n = 29), indicated 48% of the participants demonstrated at least a 50% reduction in baseline depression scores during the 16-session treatment program. Those designated as treatment responders completed more out-of-session behavioral activities, attended more treatment sessions, and demonstrated less benzodiazepine use during the program than non-responders. There were no changes in opiate and cocaine use. BTDD may be a useful adjunct to methadone maintenance for treating comorbid depressive disorders.
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]Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes. This study tested the efficacy of a newly developed psychosocial intervention, Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T), relative to psychosocial treatment as usual (TAU), for improving treatment outcomes.
Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial. [2022]Opioid use disorder (OUD) is a debilitating and relapsing psychiatric disorder; opioid agonist therapy (OAT) is the front-line, evidence-supported treatment. A substantial number of patients relapse or continue to use heroin or other illicit drugs during OAT. There is considerable heterogeneity in the OAT-resistant sub-population, with many behavioural moderators of treatment response. We have developed a personalised psychosocial intervention (PSI) targeting these individuals. A formulation-guided assessment is linked to a toolkit of motivational, cognitive/behavioural and social support techniques. Change methods have been adapted from evidence-supported psychological therapies and are idiosyncratically tailored to the need and response.
Perceived need and availability of psychosocial interventions across buprenorphine prescriber specialties. [2022]Psychosocial interventions are often recommended as part of buprenorphine treatment for patients with opioid use disorder, but little is known about prescriber perspectives on their use and how this varies across buprenorphine prescriber specialties.
Evaluating comparative effectiveness of psychosocial interventions adjunctive to opioid agonist therapy for opioid use disorder: A systematic review with network meta-analyses. [2021]Guidelines recommend that individuals with opioid use disorder (OUD) receive pharmacological and psychosocial interventions; however, the most appropriate psychosocial intervention is not known. In collaboration with people with lived experience, clinicians, and policy makers, we sought to assess the relative benefits of psychosocial interventions as an adjunct to opioid agonist therapy (OAT) among persons with OUD.
Outcomes for patients receiving telemedicine-delivered medication-based treatment for Opioid Use Disorder: A retrospective chart review. [2022]This report builds on a previous study that describes the collaboration between an urban academic medical center and a rural drug treatment center, the goal of which is to provide medication-based treatment to individuals with OUD via videoconferencing. We describe results of a retrospective chart review of 472 patients treated in the program between August 2015 and April 2019. We examined several demographic and substance use variables for individuals who consented to telemedicine treatment, retention in treatment over time, and opioid use over time to understand further the impact of prescribing buprenorphine and naltrexone via telemedicine to patients in a rural OUD treatment setting. Our findings support the effectiveness of prescribing medications via telemedicine. The inclusion of more than three times as many patients as in our prior report revealed retention rates and toxicology results that are comparable to face-to-face treatment. These findings have implications for policymakers and clinicians considering implementation of similar programs.
Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. [2022]Treatment for opioid use disorder (OUD) may include a combination of pharmacotherapies (such as buprenorphine) with counseling services if clinically indicated. Medication management or engagement with in-person counseling services may be hindered by logistical and financial barriers. Telehealth may provide an alternative mechanism for continued engagement. This study aimed to evaluate the association between telehealth encounters and time to discontinuation of buprenorphine treatment when compared to traditional in-person visits and to evaluate potential effect modification by rural-urban designation and in-person and telehealth combination treatment.
Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. [2022]Opioid use disorder (OUD) is a public health crisis affecting 2 million Americans. Approximately 80% of people with OUD do not receive treatment, and attrition rates in treatment programs are as high as 80%. Previous research has shown intensive outpatient treatment (IOT) has positive outcomes, but enrollment and retention in programs are problematic. To improve outcomes and increase engagement, more information is needed about how persons experience IOT programs. The purpose of this study is to describe processes that people with OUD undergo as they participate in IOT programs.
The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. [2022]Psychosocial interventions are needed to enhance patient engagement and retention in medication treatment within opioid treatment programs. Measurement-based care (MBC), an evidence-based intervention structure that involves ongoing monitoring of treatment progress over time to assess the need for treatment modifications, has been recommended as a flexible and low-cost intervention for opioid treatment program use. The MBC2OTP Project is a two-phase pilot hybrid type 1 effectiveness-implementation trial that has three specific aims: (1) to employ Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) to collect mixed methods data to inform MBC implementation; (2) to use RAPICE data to adapt an MBC protocol; and (3) to conduct a hybrid type 1 trial to evaluate MBC's preliminary effectiveness and implementation potential in opioid treatment programs.
Defining and supporting high-quality telehealth for patients with opioid use disorder: The promise and potential pitfalls of telehealth expansion. [2023]Many patients with opioid use disorders do not receive evidence-based treatment. The COVID-19 pandemic expanded the use of telehealth for prescribing medications for opioid use disorder (OUD). The uptake of telehealth has been variable, and this uneven expansion has created natural experiments to test assumptions and answer key questions about what improves outcomes for patients with OUD. Many current quality of care measures are not patient centered and do not focus on the practical questions that clinicians face. What criteria should be met before prescribing buprenorphine? Are physical exams necessary? Does the frequency and type of drug testing predict clinical outcomes? Are short check-in visits by phone or video better than less frequent in-person visits? Answering these questions can help define the essential components of high-quality care for patients with OUD. Defining the features of high-quality care can help create guardrails that will help protect our patients from potentially exploitive and ineffective care. Telehealth will likely end up being one additional tool to deliver care, but the scientific questions that can be answered during this period of rapid change can help answer some of the fundamental questions about providing high-quality care-and that will help all our patients, no matter how care is delivered.
When a pandemic and epidemic collide: Lessons learned about how system barriers can interrupt implementation of addiction research. [2023]Telehealth technologies are now featured more prominently in addiction treatment services than prior to the COVID-19 pandemic, but system barriers should be carefully considered for the successful implementation of innovative remote solutions for medication management and recovery coaching support for people with opioid use disorder (OUD).