Opiate DependenceRODISCNCT01779973
Remote Observed Dosing to Increase Suboxone Compliance
A study testing Remote Observed Dosing in people with Opiate Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Remote Observed Dosing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Sep 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent prior to the conduct of any study-related procedure
- Male or female, 18 to 65 years of age,
- Meet DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of contraception
- Owns a smartphone with forward facing camera that allows for use of Skype
Who cannot join
- University of Pennsylvania student, employee, or affiliate
- Current diagnosis of AIDS
- Presence of AST and/or ALT equal to or 3X upper limit of normal
- Total bilirubin and/or creatinine equal to or 1.5X upper limit or normal
- Current diagnosis of chronic pain requiring opioids
- Pregnant or lactating females
Show all 13Show fewer
- Previous hypersensitivity or allergy to buprenorphine or EVA-containing substances
- Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and protease inhibitors (e.g. ritonavir, indinavir, saquinavir)
- Meet DSM-IV criteria for current dependence on any psychoactive substances other than opioids or nicotine (e.g. alcohol, sedatives)
- Current use of benzodiazepines other than physician prescribed
- Significant medical or psychiatric symptoms or dementia which in the opinion of the investigators would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent
- Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in the study; and/or any pending legal action that could prohibit participation and/or compliance in study procedures
- Participated in a clinical study within the previous 8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).
- Conditions
- Opiate Dependence
- Being tested
- Remote Observed Dosing
- Keywords
- Skype, compliance, remote dosing, suboxone, opiate, opiates, heroin, oxycontin, Philadelphia
- Medical subject headings
- Opioid-Related Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Observed DosingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Remote Observed Dosing | Experimental | Compliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit. Receives: Behavioral: Remote Observed Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study.
Measured: 9 months
Secondary outcomes (1)
Patterns of missed doses including visit times and frequency impact.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer G Plebani, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779973
- Sponsor's protocol ID
- 816651
- Acronym
- RODISC
- Status last verified
- Apr 2017
- First submitted
- 28 Jan 2013
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Observed Dosing to Increase Suboxone Compliance
- ClinicalTrials.gov ID
- NCT01779973
- Acronym / sponsor ID
- RODISC / 816651
- Conditions
- Opiate Dependence
- Keywords
- Skype, compliance, remote dosing, suboxone, opiate, opiates, heroin, oxycontin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jan 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 goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Observed Dosing | Experimental | Behavioral: Remote Observed DosingCompliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily provide written informed consent prior to the conduct of any study-related procedure
- Male or female, 18 to 65 years of age,
- Meet DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of contraception
- Owns a smartphone with forward facing camera that allows for use of Skype
Key exclusion criteria (13 listed)
- University of Pennsylvania student, employee, or affiliate
- Current diagnosis of AIDS
- Presence of AST and/or ALT equal to or 3X upper limit of normal
- Total bilirubin and/or creatinine equal to or 1.5X upper limit or normal
- Current diagnosis of chronic pain requiring opioids
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 |
|---|---|---|
| Remote Observed Dosing | Behavioural | Remote Observed Dosing |
Primary outcome
The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study.
Time frame: 9 months
1 secondary outcome
Patterns of missed doses including visit times and frequency impact.
Time frame: 9 months
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 7 Nov 2017.
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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.
Jennifer G Plebani, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Observed Dosing in people with Opiate Dependence, run by University of Pennsylvania 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 5 inclusion and 13 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 7 Nov 2017. 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?
The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study. (time frame: 9 months). 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 7 Nov 2017.