scholarly journals Patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder: protocol for a randomized controlled open-label, decentralized trial (Preprint)

10.2196/32759 ◽  
2021 ◽  
Author(s):  
Hilary Luderer ◽  
Lisa Chiodo ◽  
Amanda Wilson ◽  
Christina Brezing ◽  
Suky Martinez ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Open Label ◽  
Randomized Controlled

scholarly journals Comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder: Protocol for an open-label, parallel-group, superiority, randomized controlled trial

2020 ◽  
Author(s):  
James S.H. Wong ◽  
Mohammadali Nikoo ◽  
Jean N. Westenberg ◽  
Janet G. Suen ◽  
Jennifer Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Controlled Trial ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Induction Method ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Successful Induction

Background: Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD). The standard induction method of buprenorphine/naloxone requires patients to be abstinent from opioids and therefore experience withdrawal symptoms prior to induction, which can be a barrier in starting treatment. Rapid micro-induction (micro-dosing) involves the administration of small, frequent does of buprenorphine/naloxone and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone in patients with OUD. Methods: This is a randomized, open-label, two-arm, superiority, controlled trial comparing the safety and effectiveness of rapid micro-induction versus standard induction of buprenorphine/naloxone for the treatment of OUD. A total of 50 participants with OUD will be randomized at one Canadian hospital. The primary outcome is successful induction of buprenorphine/naloxone with low levels of withdrawal. Secondary outcomes are treatment retention, illicit drug use, self-reported drug use behaviour, craving, pain, physical health, safety, and client satisfaction. Discussion: This is the first randomized controlled trial to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone. This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis.

Patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder: protocol for a randomized controlled open-label, decentralized trial (Preprint)

2021 ◽  
Author(s):  
Hilary Luderer ◽  
Lisa Chiodo ◽  
Amanda Wilson ◽  
Christina Brezing ◽  
Suky Martinez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Patient Engagement ◽  
Behavioral Treatment ◽  
Controlled Trial ◽  
Treatment Success ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Delivery Format

BACKGROUND Prescription digital therapeutics (PDTs) are software-based disease treatments that are regulated by the U.S. Food and Drug Administration (FDA). The reSET-O® PDT was FDA-authorized in 2018 and delivers behavioral treatment for individuals receiving buprenorphine for opioid use disorder (OUD). Although reSET-O improves outcomes for individuals with OUD, most of the therapeutic content is delivered as narrative text. PEAR-008 is an investigational device based on reSET-O that uses an interactive, game-based platform to deliver similar therapeutic content designed to enhance patient engagement, which may further improve treatment outcomes. OBJECTIVE The primary objective of this trial is to compare PEAR-008 to reSET-O to investigate how participants interact with the PDT’s changed delivery format. Secondary objectives include evaluating treatment success, symptoms of co-occurring mental health disorders, recovery capital, and skill development. METHODS A decentralized, randomized controlled trial (RCT) design will be utilized to compare PEAR-008 with reSET-O and evaluate differences in patient engagement with the therapeutics. The study population will consist of approximately 130 individuals with OUD (based on DSM-5 criteria) who have recently started buprenorphine for OUD (MOUD) treatment. Participants will be virtually recruited and randomly assigned to receive either PEAR-008 or reSET-O. All study sessions will be virtual and the duration of the study is 12 weeks. The primary outcome measure of engagement is operationalized as the number of active sessions per week with PEAR-008 vs. reSET-O. (An active session is any session that contains some active participation in the application such as navigating to a different screen, engaging with a learning module, or responding to a notification.) The hypothesis is that PEAR-008 will have significantly greater participant engagement compared to reSET-O. RESULTS Due to the COVID-19 pandemic, this study was re-designed using a de-centralized model as it was not possible to conduct medication initiation and study visits in person, as initially intended. Digital treatments like PDTs lend themselves well to a virtual study design. Furthermore, shifting to virtual recruitment has the added benefit of allowing a broader pool of study participants than is typically recruited by the participating study sites. This trial is actively enrolling. CONCLUSIONS This randomized controlled trial will use a decentralized study model and investigate if changing the delivery format and enhancing the content of a PDT for OUD will affect how participants use and interact with the PDT. The study design may serve as a useful model for conducting decentralized studies in this patient population.

scholarly journals Comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder: protocol for an open-label, parallel-group, superiority, randomized controlled trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
James S. H. Wong ◽  
Mohammadali Nikoo ◽  
Jean N. Westenberg ◽  
Janet G. Suen ◽  
Jennifer Y. C. Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Controlled Trial ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Induction Method ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Low Levels

Abstract Background Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD). The standard induction method of buprenorphine/naloxone requires patients to be abstinent from opioids and therefore experience withdrawal symptoms prior to induction, which can be a barrier in starting treatment. Rapid micro-induction (micro-dosing) involves the administration of small, frequent does of buprenorphine/naloxone and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone in patients with OUD. Methods This is a randomized, open-label, two-arm, superiority, controlled trial comparing the safety and effectiveness of rapid micro-induction versus standard induction of buprenorphine/naloxone for the treatment of OUD. A total of 50 participants with OUD will be randomized at one Canadian hospital. The primary outcome is the completion of buprenorphine/naloxone induction with low levels of withdrawal. Secondary outcomes are treatment retention, illicit drug use, self-reported drug use behaviour, craving, pain, physical health, safety, and client satisfaction. Discussion This is the first randomized controlled trial to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone. This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis. Trial registration ClinicalTrials.gov, NCT04234191; date of registration: January 21, 2020; https://clinicaltrials.gov/ct2/show/NCT04234191

scholarly journals Open-label dose-extending placebos for opioid use disorder: a protocol for a randomised controlled clinical trial with methadone treatment

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026604 ◽  
Author(s):  
Annabelle M Belcher ◽  
Thomas O Cole ◽  
Aaron D Greenblatt ◽  
Stephen W Hoag ◽  
David H Epstein ◽  
...  
Keyword(s):  
Placebo Effect ◽  
Methadone Treatment ◽  
Opioid Use Disorder ◽  
Treatment Seeking ◽  
Personality Factors ◽  
Placebo Effects ◽  
Opioid Use ◽  
Open Label ◽  
University Of Maryland ◽  
Study Results

IntroductionMore than 2 million individuals in the USA have an opioid use disorder (OUD). Methadone maintenance treatment is the gold standard of medication-based treatment for OUD, but high-dose methadone is associated with cardiotoxicity and respiratory complications, among other side effects. These adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal. Long recognised for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement. This approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution and may thereby be more sensitive to placebo effects. Our study combines two promising clinical methodologies—conditioning/dose-extension and open-label placebo—to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking OUD patients.Methods and analysisA total of 120 newly enrolled treatment-seeking OUD patients will be randomly assigned to one of two different groups: either methadone plus daily placebo dose-extension (PDE; treatment group) or methadone/treatment as usual (control). Participants will meet with study team members five times over the course of 3 months of treatment with methadone (baseline, 2 weeks, and 1, 2 and 3 months postbaseline). Throughout this study time period, methadone dosages will be adjusted by an addiction clinician blind to patient assignment, per standard clinical methods. The primary outcome is methadone dose at 3 months. Secondary outcomes include self-report of drug use; 3-month urine toxicology screen results; and treatment retention. Exploratory outcomes include several environmental as well as personality factors associated with OUD and with propensity to demonstrate a placebo effect.Ethics and disseminationHuman subjects oversight for this study is provided by the University of Maryland, Baltimore and University of Maryland, College Park Institutional Review Boards. Additionally, the study protocol is reviewed annually by an independent Data and Safety Monitoring Board. Study results will be disseminated via research conference presentations and peer-reviewed publications.Trial registration numberNCT02941809.

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