MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence

NCT02778282 | Completed DMC

• 2 other identifiers: 1R34DA040086 D140471R34DA040086
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 42

Secondary Outcomes (4)

• Acceptability

  Day 42

• Usability

  42 days

• Initial Clinical Efficacy-Illicit opioid use

  6 weeks

• Initial Clinical Efficacy-Medication adherence

  6 weeks

Other Outcomes (3)

• Treatment Retention

  6 weeks

• Crisis and Hardship in Administering Office-Based Opioid Treatment (OBOT) Scale

  8 weeks

• Cost effectiveness ratio

  3 months

Study Arms (2)

Standard Care

NO INTERVENTION

Standard Care through office-based opioid treatment with buprenorphine/naloxone and weekly urine toxicology screening

Standard Care + MySafeRx™ Intervention

EXPERIMENTAL

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™

Interventions

MySafeRx™ OTHER

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.

Standard Care + MySafeRx™ Intervention

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men age 18-39, inclusive, who are competent, wish to participate and willing to provide informed consent.
• DSM-V diagnosis of opioid use disorder, moderate or severe
• Seeking to initiate buprenorphine treatment or currently receiving buprenorphine treatment but had recent positive illicit opioid urine toxicology or missed scheduled urine toxicology.

You may not qualify if:

• DSM-V diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, mental retardation, or autism.
• Substantial cognitive impairment (Montreal Cognitive Assessment \< 25/30)
• Currently homeless
• Actively homicidal or suicidal with an imminent plan
• Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 3 months.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (3)

Cambridge Health Alliance Outpatient Addiction Services

Somerville, Massachusetts, 02143, United States

Location

Hawthorn Recovery Center

Bennington, Vermont, 05201, United States

Location

Mount Anthony Primary Care

Bennington, Vermont, 05201, United States

Location

Related Publications (3)

• Schuman-Olivier Z, Weiss RD, Hoeppner BB, Borodovsky J, Albanese MJ. Emerging adult age status predicts poor buprenorphine treatment retention. J Subst Abuse Treat. 2014 Sep;47(3):202-12. doi: 10.1016/j.jsat.2014.04.006. Epub 2014 May 20.

  PMID: 24953168 BACKGROUND

• Aaron Bangor, Philip T. Kortum & James T. Miller (2008) An Empirical Evaluation of the System Usability Scale, International Journal of Human-Computer Interaction, 24:6, 574-594, DOI: 10.1080/10447310802205776

  BACKGROUND

• Schuman-Olivier Z, Borodovsky JT, Steinkamp J, Munir Q, Butler K, Greene MA, Goldblatt J, Xie HY, Marsch LA. MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Addict Sci Clin Pract. 2018 Sep 24;13(1):21. doi: 10.1186/s13722-018-0122-4.

  PMID: 30249279 BACKGROUND

Related Links

• Website for Center for Technology and Behavioral Health at Dartmouth

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Zev D Schuman-Olivier, MD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Departments of Psychiatry and Biomedical Data Sciences

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: March 24, 2017
• Primary Completion: November 1, 2020
• Study Completion: August 31, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)