Medication AdherenceNCT01867476
Adherence Monitoring For Substance Abuse Clinical Trials
An observational study of Medication Adherence, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Automated Adherence Monitoring System
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2013
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Normals
Who may be able to join
- Male or female, aged 18 to 60
- Ability to give informed consent.
- Be willing and able to use the study-provided phone for taking and transmitting capsule photos.
Who cannot join
- Unwilling or unable to use a cell phone.
- Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction & Pharmacology Research Lab, St. Luke's Hospital
San Francisco, California, 94110
About this study
The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.
- Conditions
- Medication Adherence
- Being tested
- Automated Adherence Monitoring System
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Adherence Monitoring SystemOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy Normals | Not described Receives: Other: Automated Adherence Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval
Measured: + 1, 2, 3, 4, 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Creare, Inc.
- Responsible party
- Principal investigator, John Mendelson, MD, California Pacific Medical Center Research Institute
- Investigators
- John Mendelson, MD, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867476
- Sponsor's protocol ID
- 2012.075EXP
- Status last verified
- May 2013
- First submitted
- 29 Jan 2013
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Monitoring For Substance Abuse Clinical Trials
- ClinicalTrials.gov ID
- NCT01867476
- Acronym / sponsor ID
- 2012.075EXP
- Conditions
- Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- Creare, Inc.
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Jun 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 determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Normals | – | Other: Automated Adherence Monitoring System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Normals
Key inclusion criteria (3 listed)
- Male or female, aged 18 to 60
- Ability to give informed consent.
- Be willing and able to use the study-provided phone for taking and transmitting capsule photos.
Key exclusion criteria (2 listed)
- Unwilling or unable to use a cell phone.
- Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.
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 |
|---|---|---|
| Automated Adherence Monitoring System | Other | Healthy Normals |
Primary outcome
Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval
Time frame: + 1, 2, 3, 4, 6 hours post dose
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 4 Jun 2013.
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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.
John Mendelson, MD principal investigator
California Pacific Medical Center
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 Medication Adherence, run by California Pacific Medical Center Research Institute 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 3 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 4 Jun 2013. 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?
Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval (time frame: + 1, 2, 3, 4, 6 hours post dose). 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 4 Jun 2013.