CompliancePhase 2NCT02276989
Evaluation of a Compliance Marker in Prescription Opioid Abusers With Chronic Pain
A Phase 2 study testing acetazolamide, Quinine and Riboflavin in people with Compliance and Chronic Pain, run by Georgetown University at 1 site in United States.
Trial summary
In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this study will investigate the utility and feasibility of two novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor adherence to study drug prescription in… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Compliance, Chronic Pain
- What is being tested?
- acetazolamide, Quinine and Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2016
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male and female English-speaking literate adults age 18- 50 years old,
- have medically diagnosed chronic pain condition,
- be on a stable dose of buprenorphine (clinic modal dose),
- history of prescription opioid abuse,
- adequate venous access,
- if female, a negative pregnancy test. Individuals will not be accepted who are unstable in buprenorphine treatment as evidence by continued illicit drug use and irregular clinic attendance in the previous trial,
- be otherwise in good physical health or in care of a physician who is wiling to take responsibility for such treatment. The same conditions apply in cases of patients with a psychiatric disorder needing ongoing treatment.
Who cannot join
- physiologic drug dependence on benzodiazepines, barbiturates, and/or alcohol that would require medical management,
- significant ongoing medical problems (e.g., diabetes),
- history of head injury or seizure,
- serious psychiatric illness outside of drug use (e.g., schizophrenia),
- recent use of any agent that inhibits or induces cytochrome P450 3A4 or 2D6,
- nursing or pregnant female, or a female or male who does not agree to not become pregnant or father a child during the course of, and three months following completion of the study,
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- have a cardiac conduction or blood clotting disorder,
- blood donation within the past 30 days prior to screening,
- clinically significant laboratory results (as judged by the investigator/sub-investigator)
- moderate to severe COPD,
- renal impairment, and
- severe renal hepatic impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Evaluation of a Compliance Marker A Supplement to: U01DA029580-02 Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of Pregabalin
In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this study will investigate the utility and feasibility of two novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor adherence to study drug prescription in the parent clinical trial.
Read the detailed description
In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this supplement study will investigate the utility and feasibility of two novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor adherence to study drug prescription in the parent clinical trial (NCT01821430).
- We will examine the ability of two benign (in the doses used) medications, quinine (80mg) and acetazolamide (15mg) to serve as valid and reliable markers of medication use. The relative utility of each will be described for use with the study medication (PGB 400mg/day), a drug dependent on primarily renal excretion. In that both PGB and acetazolamide are eliminated unchanged in the urine, we will examine if the latter can be used without altering the elimination rate of the former, or whether a maker with both hepatic and renal modes of elimination (quinine) would serve as a better indicator of adherence in the trial.
- Being a standard in clinical trials, the medication adherence marker riboflavin is used in the parent study (NCT01821430), as it can be readily detected in urine samples by simple visual inspection. However, riboflavin is a relatively gross indicator of medication use; it does not reside in the body for the time period typically required in outpatient trials, can be affected by dietary riboflavin and has variable absorption. Capitalizing on riboflavin's ease of detection, the second aim of this supplement will be to examine whether riboflavin when combined with one of the new candidate tracers, can provide a superior indicator of adherence, in that riboflavin can be qualitatively observed immediately, and the other tracer being quantitatively detected during subsequent urine toxicology analyses.
The cross over design of the study will allow us to address these aims in an efficient and straightforward manner. Following examination of the pharmacokinetics (PK) of PGB alone, it's PK will then be reexamined when compounded with acetazolamide, and again with both acetazolamide and riboflavin present. Next, after a short washout period, the studies PGB PK will be repeated with acetazolamide replaced by quinine. If the new tracers do not interfere with the PK of PGB, one of them will be chosen to be formulated (along with riboflavin) with PGB for use in the parent study, thereby providing both qualitative and quantitative indicators of adherence.
- Conditions
- Compliance, Chronic Pain
- Being tested
- acetazolamide, Quinine, Riboflavin
- Keywords
- Chronic Pain, Compliance Marker, Narcotic Abuse, Opioid related disorders, Opiate substitution treatment, Buprenorphrine, Suboxone, Lyrica, Pregabalin, Acetazolamide, Quinine, Compliance
- Medical subject headings
- Patient Compliance, Chronic Pain, Narcotic-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
Also called ACZ
On evening of Day 0, subjects will arrive at the session previously stabilized on buprenorphine and pregabalin. Pregabalin titration = 6 days prior to Day 0, during which time they will receive 100mg/day x 2 days, 200mg/day x2 days, and 300mg/day x 2 days, with the subjects receiving the full dose of 400mg/day beginning Day 0.
On Day 1, pregabalin PK measures will be collected.
On the mornings (8am) of Days 1 - 5, PGB compounded with the first tracer, ACZ will be administered.
On Day 5, subjects will again undergo PK testing on PGB + ACZ tracer.
On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected.
On the mornings of Days 7-8 subjects will receive their PGB dose only.
QuinineDrug
Also called QUIN
On the morning of Days 8-11, subjects will be administered the same dose of PGB, now compounded with the QUIN.
On Day 11, PK testing of QUIN and PGB will be repeated.
On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected.
On Day 13 patients will be discharged with take-home doses of PGB that will taper to zero over the period of one week.
RiboflavinDrug
Also called Vitamin B2
All subjects will receive riboflavin on the following days of the study:
On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected.
On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected.
| Study group | Role | What they receive |
|---|---|---|
| Compliance Intervention | Experimental | Subjects will receive acetazolamide, quinine and riboflavin as experimental compliance markers and will serve as their own controls. Receives: Drug: acetazolamide; Drug: Quinine; Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profiles for each medication/tracer (assayed from blood and urine samples) and will include parameters such as AUC, CMAX, TMax, and t1/2.
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peggy Compton, Georgetown University
- Investigators
- Peggy Compton, RN, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276989
- Sponsor's protocol ID
- 2013-0751
- Status last verified
- Feb 2017
- First submitted
- 21 Oct 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Compliance Marker A Supplement to: U01DA029580-02 Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of Pregabalin
- ClinicalTrials.gov ID
- NCT02276989
- Acronym / sponsor ID
- 2013-0751
- Conditions
- Compliance, Chronic Pain
- Keywords
- Chronic Pain, Compliance Marker, Narcotic Abuse, Opioid related disorders, Opiate substitution treatment, Buprenorphrine, Suboxone, Lyrica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Oct 2014 (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.
In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this study will investigate the utility and feasibility of two novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor adherence to study drug prescription in the parent clinical trial.
Detailed description
In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this supplement study will investigate the utility and feasibility of two novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor adherence to study drug prescription in the parent clinical trial (NCT01821430).
- We will examine the ability of two benign (in the doses used) medications, quinine (80mg) and acetazolamide (15mg) to serve as valid and reliable markers of medication use. The relative utility of each will be described for use with the study medication (PGB 400mg/day), a drug dependent on primarily renal excretion. In that both PGB and acetazolamide are eliminated unchanged in the urine, we will examine if the latter can be used without altering the elimination rate of the former, or whether a maker with both hepatic and renal modes of elimination (quinine) would serve as a better indicator of adherence in the trial.
- Being a standard in clinical trials, the medication adherence marker riboflavin is used in the parent study (NCT01821430), as it can be readily detected in urine samples by simple visual inspection. However, riboflavin is a relatively gross indicator of medication use; it does not reside in the body for the time period typically required in outpatient trials, can be affected by dietary riboflavin and has variable absorption. Capitalizing on riboflavin's ease of detection, the second aim of this supplement will be to examine whether riboflavin when combined with one of the new candidate tracers, can provide a superior indicator of adherence, in that riboflavin can be qualitatively observed immediately, and the other tracer being quantitatively detected during subsequent urine toxicology analyses.
The cross over design of the study will allow us to address these aims in an efficient and straightforward manner. Following examination of the pharmacokinetics (PK) of PGB alone, it's PK will then be reexamined when compounded with acetazolamide, and again with both acetazolamide and riboflavin present. Next, after a short washout period, the studies PGB PK will be repeated with acetazolamide replaced by quinine. If the new tracers do not interfere with the PK of PGB, one of them will be chosen to be formulated (along with riboflavin) with PGB for use in the parent study, thereby providing both qualitative and quantitative indicators of adherence.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compliance Intervention | Experimental | Drug: acetazolamide, Drug: Quinine, Drug: RiboflavinSubjects will receive acetazolamide, quinine and riboflavin as experimental compliance markers and will serve as their own controls. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male and female English-speaking literate adults age 18- 50 years old,
- have medically diagnosed chronic pain condition,
- be on a stable dose of buprenorphine (clinic modal dose),
- history of prescription opioid abuse,
- adequate venous access,
Key exclusion criteria (12 listed)
- physiologic drug dependence on benzodiazepines, barbiturates, and/or alcohol that would require medical management,
- significant ongoing medical problems (e.g., diabetes),
- history of head injury or seizure,
- serious psychiatric illness outside of drug use (e.g., schizophrenia),
- recent use of any agent that inhibits or induces cytochrome P450 3A4 or 2D6,
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 |
|---|---|---|
| acetazolamideAlso: ACZOn evening of Day 0, subjects will arrive at the session previously stabilized on buprenorphine and pregabalin. Pregabalin titration = 6 days prior to Day 0, during which time they will receive 100mg/day x 2 days, 200mg/day x2 days, and 300mg/day x 2 days, with the subjects receiving the full dose of 400mg/day beginning Day 0. On Day 1, pregabalin PK measures will be collected. On the mornings (8am) of Days 1 - 5, PGB compounded with the first tracer, ACZ will be administered. On Day 5, subjects will again undergo PK testing on PGB + ACZ tracer. On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected. On the mornings of Days 7-8 subjects will receive their PGB dose only. | Drug | Compliance Intervention |
| QuinineAlso: QUINOn the morning of Days 8-11, subjects will be administered the same dose of PGB, now compounded with the QUIN. On Day 11, PK testing of QUIN and PGB will be repeated. On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected. On Day 13 patients will be discharged with take-home doses of PGB that will taper to zero over the period of one week. | Drug | Compliance Intervention |
| RiboflavinAlso: Vitamin B2All subjects will receive riboflavin on the following days of the study: On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected. On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected. | Drug | Compliance Intervention |
Primary outcome
Pharmacokinetic profiles for each medication/tracer (assayed from blood and urine samples) and will include parameters such as AUC, CMAX, TMax, and t1/2.
Time frame: 26 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Peggy Compton, RN, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetazolamide, Quinine and Riboflavin in people with Compliance and Chronic Pain, run by Georgetown University 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 12 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: withdrawn, as of the sponsor's last update on 10 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic profiles for each medication/tracer (assayed from blood and urine samples) and will include parameters such as AUC, CMAX, TMax, and t1/2. (time frame: 26 days). 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 10 Feb 2017.