Evaluation of a Compliance Marker in Prescription Opioid Abusers With Chronic Pain
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| ClinicalTrials.gov Identifier: NCT02276989 |
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Recruitment Status :
Withdrawn
(poor recruitment)
First Posted : October 28, 2014
Last Update Posted : February 10, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Compliance Chronic Pain | Drug: acetazolamide Drug: Quinine Drug: Riboflavin | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Evaluation of a Compliance Marker A Supplement to: U01DA029580-02 Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of Pregabalin |
| Study Start Date : | December 2014 |
| Actual Primary Completion Date : | January 2016 |
| Actual Study Completion Date : | January 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Compliance Intervention
Subjects will receive acetazolamide, quinine and riboflavin as experimental compliance markers and will serve as their own controls.
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Drug: acetazolamide
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. Other Name: ACZ Drug: Quinine 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. Other Name: QUIN Drug: Riboflavin 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. Other Name: Vitamin B2 |
- 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 ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276989
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| Principal Investigator: | Peggy Compton, RN, PhD | Georgetown University |
| Responsible Party: | Peggy Compton, Professor and Associate Dean, Georgetown University |
| ClinicalTrials.gov Identifier: | NCT02276989 |
| Other Study ID Numbers: |
2013-0751 |
| First Posted: | October 28, 2014 Key Record Dates |
| Last Update Posted: | February 10, 2017 |
| Last Verified: | February 2017 |
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Chronic Pain Compliance Marker Narcotic Abuse Opioid related disorders Opiate substitution treatment Buprenorphrine |
Suboxone Lyrica Pregabalin Acetazolamide Quinine Compliance |
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Chronic Pain Pain Neurologic Manifestations Riboflavin Quinine Acetazolamide Vitamins Micronutrients Physiological Effects of Drugs Vitamin B Complex Photosensitizing Agents Dermatologic Agents Anticonvulsants Carbonic Anhydrase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |