Adaptive Interventions for Opioid Use Disorder (ADAPT-ED Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: RAND
No Placebo Group
Trial Summary
What is the purpose of this trial?The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable opioid use disorder (OUD).
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's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment ED-ITT, ED-ITT + BHS, SUN, SUN + Telebridge for opioid use disorder?
Research suggests that adding computer-based cognitive-behavioral therapy (CBT) and recovery coaching to buprenorphine treatment can help reduce substance use and improve recovery outcomes for people with opioid use disorder. Additionally, telephonic patient support has been shown to improve compliance and treatment outcomes in opioid dependence.
12345Is the treatment for opioid use disorder safe for humans?
The safety of digital therapeutics for opioid use disorder has been evaluated in clinical trials, and these treatments have been authorized by the U.S. Food and Drug Administration (FDA) for use, indicating they are generally considered safe for humans.
678910How is the treatment ED-ITT, ED-ITT + BHS, SUN, SUN + Telebridge unique for opioid use disorder?
This treatment is unique because it combines different adaptive interventions, including emergency department-initiated treatment (ED-ITT) and behavioral health support (BHS), with technology-enhanced options like SUN and Telebridge, aiming to personalize and improve engagement in opioid use disorder care.
13111213Eligibility Criteria
This trial is for English or Spanish-speaking adults over 18 who come to the ED with probable opioid use disorder (OUD) and can consent to participate. They must sign a consent form. People are excluded if they don't meet these criteria.Inclusion Criteria
I am 18 years old or older.
I can speak and understand either English or Spanish.
I understand the details of the clinical trial and can agree to participate.
Participant Groups
The ADAPT-ED study tests different combinations of interventions like SUN + Telebridge, ED-ITT, SUN alone, and ED-ITT + BHS in a two-stage process to see which helps increase long-term buprenorphine use in patients with OUD.
6Treatment groups
Active Control
Group I: SUN with no follow upActive Control1 Intervention
In Arm A, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be responders by 90 days and therefore receive no active follow up.
Group II: SUN followed by ED-ITTActive Control2 Interventions
In Arm B, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition during which they receive ongoing buprenorphine treatment by an ED-based interim treatment team.
Group III: SUN + Telebridge followed by ED-ITT + BHSActive Control2 Interventions
In Arm F, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition during which they receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.
Group IV: SUN + Telebridge with no follow upActive Control1 Intervention
In Arm D, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be responders by 90 days and therefore receive no active follow up.
Group V: SUN followed by ED-ITT + BHSActive Control2 Interventions
In Arm C, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition during which they receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.
Group VI: SUN + Telebridge followed by ED-ITTActive Control2 Interventions
In Arm E, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition during which they receive ongoing buprenorphine treatment by an ED-based interim treatment team.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Arrowhead Regional Medical CenterColton, CA
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Who is running the clinical trial?
RANDLead Sponsor
Stanford UniversityCollaborator
Arrowhead Regional Medical CenterCollaborator
Alameda Health SystemCollaborator
References
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.
Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study. [2022]Opioid use disorder (OUD) has led to a staggering death toll in terms of drug-related overdoses. Despite the demonstrated benefits and effectiveness of buprenorphine, retention is suboptimal, and patients typically present with high rates of ongoing polysubstance use during treatment. A pilot trial provided preliminary support for the efficacy of computer-based cognitive-behavioral therapy (CBT4CBT) as an add-on to buprenorphine in reducing substance use. Recovery coaching services provided by individuals with substance use experience and successful recovery have also shown to positively influence recovery outcomes for people with OUD by increasing buprenorphine initiation and reducing opioid use.
Adaptive interventions for opioid prescription management and consumption monitoring. [2023]While opioid addiction, treatment, and recovery are receiving attention, not much has been done on adaptive interventions to prevent opioid use disorder (OUD). To address this, we identify opioid prescription and opioid consumption as promising targets for adaptive interventions and present a design framework.
Patient Activation of Persons With Opioid Use Disorder in Intensive Outpatient Treatment. [2022]High patient activation is associated with a variety of positive health outcomes. Although increasing patient activation in persons with opioid use disorder (OUD) in intensive outpatient treatment (IOT) programs may increase engagement and improve outcomes, little is known about how patient activation is manifested in these programs.
The effect of telephonic patient support on treatment for opioid dependence: outcomes at one year follow-up. [2013]The present study examined the impact of a telephonic patient support program known as HereToHelp™ (HTH) on compliance and treatment outcomes among opioid dependent (OD) patients new to buprenorphine treatment (BUP).
Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]To evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253).
Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. [2022]Increasing awareness of, and information about, overdose risk is an appropriate approach in risk reduction. e-Health technology in substance use disorders is an opportunity to support behavioral changes related to public health concerns. The present study aimed to evaluate the short-term impact of an innovative e-health psychoeducational software, the Overdose RIsk InfOrmatioN (ORION) tool. The ORION programme provided relevant information to opioid-dependent individuals about the risk of suffering a drug overdose as a result of high risky and dysfunctional behaviors. Seven aggregate risk factors were identified through a systematic review and their outputs included in a risk estimation model. We recruited 194 opioid-dependent treatment-seeking individuals from the United Kingdom, Germany, Italy, and Denmark. All participants were given at study entry, and after their use of the software, the General Self-Efficacy (GSE) Scale. We found comparable pre- and post-ORION administration mean GSE scores (SD), 28.49 (5.50) and 28.32 (5.90), respectively (p = 0.297). However, there was an inverse correlation between the number of risk factors and reported levels of self-efficacy (p
Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]To evaluate patient engagement and usage of a prescription digital therapeutic (PDT) and associated outcomes of opioid use and treatment retention in a large real-world dataset of patients with opioid use disorder (OUD) treated with buprenorphine medication for opioid use disorder (MOUD). PDTs are software-based disease treatments evaluated for safety and effectiveness in randomized clinical trials (RCTs), and authorized by the U.S. Food and Drug Administration (FDA) to treat disease with approved directions for use (label).
ED-based Counseling Sessions Reduce Risky Opioid Use Among Certain Patients. [2018]Investigators at the University of Michigan have shown promising results from an ED-based intervention designed to curb risky opioid use among patients who have reported opioid misuse within the previous three months. The intervention includes a 30-minute counseling session with a therapist who utilizes motivational interviewing techniques to strengthen their desire to move away from opioid use behaviors. The randomized clinical trial included 204 emergency patients, divided between patients receiving printed educational materials and patients receiving printed materials as well as counseling sessions. Researchers followed up with all patients after six months, finding that those who received the counseling intervention demonstrated a substantially higher reduction in behaviors that heighten the risk of an overdose than patients who received only printed materials. Investigators are working now to adapt the counseling intervention so that it can be delivered by more cost-efficient,means, such as via interactive voice response messages or computer.
Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]To describe the development of an interactive, web-based self-management intervention for opioid-treated, chronic pain patients with aberrant drug-related behavior.
A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. [2021]Opioid use disorder (OUD) is a public health crisis with more than 2 million people living with OUD in the United States. Medication-assisted treatment (MAT) is an evidence-based approach for the treatment of OUD that relies on a combination of behavioral therapy and medication. Less than half of those living with OUD are accessing this treatment. Mobile technology can enhance the treatment of chronic diseases in readily accessible and cost-effective ways through self-monitoring and support.
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.
Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. [2023]The diagnosis of Opioid Use Disorder (OUD) during pregnancy has increased 2-to-5-fold over the past decade and barriers to treatment are significant. Technology-based solutions have the potential to overcome these barriers and deliver evidence-based treatment. However, these interventions need to be informed by end-users. The goal of this study is to gain feedback from peripartum people with OUD and obstetric providers about a web-based OUD treatment program.