An interventional study of MySafeRx™ in Opioid Use Disorder, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
The goal of the MySafeRx study is to evaluate the feasibility, acceptability, and usability of a novel platform that integrates text messaging reminders, secure electronic pill organizers, and daily remote brief motivational recovery support visits with a standardized protocol for supervised self- administration of buprenorphine via videoconferencing.
Opioid use disorder is a serious public health issue. Buprenorphine/ Naloxone (B/N) is a partial opioid mu-receptor agonist dosed daily that prevents opioid withdrawal, blocks opioid euphoria and can prevent opioid overdose. Extended treatment with B/N increases rates of abstinence and outpatient treatment retention and decreases Hepatitis C (HCV) transmission. B/N treatment dropout is associated with relapse and overdose death.
B/N adherence may be a critical factor influencing retention and reducing overall healthcare costs. Also, B/N diversion is associated with poor adherence and has become increasingly common and worrisome. While many patients achieve stability after starting B/N treatment, more than 80% of 18-25 year olds leave treatment within a year with relapse as the most common reason. Ongoing illicit opioid use during treatment increases odds of relapse and dropout. The MySafeRx™ platform helps prescribers offer a higher level of support for vulnerable patients with opioid use disorder during periods of clinical instability. The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of B/N medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. By offering this recovery support and medication adherence monitoring program during periods of instability, this system could improve treatment outcomes by ensuring increased adherence, while also preventing B/N diversion.
This study primarily seeks to demonstrate the feasibility, acceptability, and usability of the MySafeRx™ platform among young adults (18-39 years, inclusive) with opioid use disorders. While each key component may have an individual therapeutic effect, we hypothesize that an integrated process involving all key components may be necessary to unlock the full therapeutic potential of a mobile platform for daily remote supervised self-administration and diversion prevention among this group. Providing targeted motivational interviewing and recovery support at this context-specific moment of daily medication-taking when people are very receptive to treatment may offer a new opportunity for expanding how recovery support can be delivered. Usability will be assessed with the validated system usability scale as a primary outcome. Feasibility, acceptability and initial efficacy based on opioid urine toxicology will all be assessed as secondary outcomes.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 27 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard Care through office-based opioid treatment with buprenorphine/naloxone and weekly urine toxicology screening
The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. This arm represents Standard Care plus MySafeRx™.
Other: MySafeRx™
The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
Percent of subjects with adequate medication adherence
Feasibility will be demonstrated by MySafeRx achieving supervised self-administration of B/N on \>= 30 out of the first 42 days (equivalent to an average of 5 out of 7 days) for at least 2/3 of subjects randomized to MySafeRx.
Time frame: Day 42
Acceptability
Level of patient acceptability (mean score \> 3 out of 5 on the 13-item satisfaction scale)
Time frame: Day 42
Usability
Reported patient usability (mean score \> 68 on the system usability scale)
Time frame: 42 days
Initial Clinical Efficacy-Illicit opioid use
Percent negative weekly opioid urine toxicology
Time frame: 6 weeks
Initial Clinical Efficacy-Medication adherence
Weekly self-reports of B/N adherence
Time frame: 6 weeks
Treatment Retention
Percentage of patients dropped out from treatment or referred to higher level of care
Time frame: 6 weeks
Crisis and Hardship in Administering Office-Based Opioid Treatment (OBOT) Scale
Monthly CHAOS scale scores
Time frame: 8 weeks
Cost effectiveness ratio
Assess cost effectiveness ratio for prescribers and patients from MySafeRx™ versus standard care, which is the following \[CE Ratio = (Cost{new}-Cost{current}) /(Effect{new}-Effect{current})
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center