Opioid DependenceNCT02017041
Using mHealth to Aid Opioid Medication Adherence Pilot Study
An observational study of Opioid Dependence, run by Care Team Solutions at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Medsignals and smartphone app
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- At least 21 years of age
- Physician diagnosis of opioid dependence (OD)
- Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.
- Able to speak and read English
- Willing to provide written informed consent prior to study entry
- Able to understand the study
- Ownership of an Android or iPhone smartphone
Who cannot join
- Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
- Cognitive or other impairment that would interfere with completing a self-administered questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.
Read the detailed description
The purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named SubAID. The SubAID system is a smartphone application and medication monitor designed to optimize adherence behaviors of an OD patient responsible for administering bup/nal maintenance therapy medication.
Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing OST.
- Stage 1 - 1 week: Participants will use only an electronic medication monitor (MedSignals) in control mode to passively record baseline adherence to medication.
- Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone application.
- Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone application.
After each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.
- Conditions
- Opioid Dependence
- Being tested
- Medsignals, smartphone app
- Keywords
- opioid dependence, buprenorphine, smartphone, suboxone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedsignalsDevice
MedSignals (www.medsignals.com) is a cellular communicating medication management device designed to improve adherence. It will be used to track when medication is removed from the device at dosing times and deliver audible and visual alerts at dosing times and to relay adherence data securely to patient files. Participants will use this device throughout the 5-week trial. It is a Class I device.
smartphone appDevice
The smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone.
| Study group | Role | What they receive |
|---|---|---|
| buprenorphine/naloxone | Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app. Receives: Device: Medsignals; Device: smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire assessing usability of the system.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Care Team Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Bailey, PhD, Study director, Care Team Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017041
- Sponsor's protocol ID
- HHSN271201300015C-1
- Other IDs
- HHSN271201300015C
- Status last verified
- Feb 2015
- First submitted
- 9 Dec 2013
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using mHealth to Aid Opioid Medication Adherence Pilot Study
- ClinicalTrials.gov ID
- NCT02017041
- Acronym / sponsor ID
- HHSN271201300015C-1
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, buprenorphine, smartphone, suboxone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Care Team SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.
Detailed description
The purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named SubAID. The SubAID system is a smartphone application and medication monitor designed to optimize adherence behaviors of an OD patient responsible for administering bup/nal maintenance therapy medication.
Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing OST.
- Stage 1 - 1 week: Participants will use only an electronic medication monitor (MedSignals) in control mode to passively record baseline adherence to medication.
- Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone application.
- Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone application.
After each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| buprenorphine/naloxone | – | Device: Medsignals, Device: smartphone appOpioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (7 listed)
- At least 21 years of age
- Physician diagnosis of opioid dependence (OD)
- Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.
- Able to speak and read English
- Willing to provide written informed consent prior to study entry
Key exclusion criteria (2 listed)
- Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
- Cognitive or other impairment that would interfere with completing a self-administered questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedsignalsMedSignals (www.medsignals.com) is a cellular communicating medication management device designed to improve adherence. It will be used to track when medication is removed from the device at dosing times and deliver audible and visual alerts at dosing times and to relay adherence data securely to patient files. Participants will use this device throughout the 5-week trial. It is a Class I device. | Device | buprenorphine/naloxone |
| smartphone appThe smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone. | Device | buprenorphine/naloxone |
Primary outcome
questionnaire assessing usability of the system.
Time frame: up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bailey, PhD study director
Care Team Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence, run by Care Team Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire assessing usability of the system. (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015; AzTrials last refreshed its copy on 31 Oct 2026.