Opioid Use Disorder Clinical Trial
Official title:
MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE)
Verified date | December 2018 |
Source | Cambridge Health Alliance |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of the MyMOBILE 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.
Status | Completed |
Enrollment | 12 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: Participants must: 1. Be between the ages of 18 and 39 years old. 2. Be able to provide informed consent. 3. Be clinically diagnosed with opioid dependence (DSM-IV) or opioid use disorder (DSM-5). 4. Be currently in Medication-Assisted Treatment (MAT) with buprenorphine. 5. Test positive for illicit opioid use within the past week. 6. Have an Android smartphone or tablet device with current access to the internet through secure WiFi and/or a mobile data plan. 7. Be able to meet in a confidential place for scheduled videoconferencing call with Mobile Recovery Coach on a daily basis. Exclusion Criteria: Participants must not: 1. Be younger than 18 or older than 39 years of age. 2. Be non-English speaking. 3. Be otherwise unable to complete informed consent. 4. Be in their third trimester of pregnancy. 5. Have cognitive deficits that may limit their ability to complete study procedures. 6. Receive a twice daily prescription of buprenorphine. 7. Exhibit use of an illicit substance or prescribed medication considered by the PI to be unsafe for use with the MySafeRx device or study procedures. 8. Exhibit signs of severe mental illness such as psychoses, present with active suicidal ideation, or otherwise be a risk to themselves or others. |
Country | Name | City | State |
---|---|---|---|
United States | Cambridge Health Alliance | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cambridge Health Alliance | Dartmouth College, MedicaSafe, Inc., MySafeRx, Inc |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence | Feasibility will be measured by percentage of study days with confirmation of supervised self-administration of medication. | 4 weeks | |
Primary | Usability | Level of patient usability as measured by system usability scale | 2 weeks, 4 weeks | |
Primary | Acceptability | Level of patient acceptability of system | 4 weeks |
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