Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02276989
Other study ID # 2013-0751
Secondary ID
Status Withdrawn
Phase Phase 2
First received October 21, 2014
Last updated February 8, 2017
Start date December 2014
Est. completion date January 2016

Study information

Verified date February 2017
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 the parent clinical trial.


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).

1. 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.

2. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. male and female English-speaking literate adults age 18- 50 years old,

2. have medically diagnosed chronic pain condition,

3. be on a stable dose of buprenorphine (clinic modal dose),

4. history of prescription opioid abuse,

5. adequate venous access,

6. 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,

7. 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:

1. physiologic drug dependence on benzodiazepines, barbiturates, and/or alcohol that would require medical management,

2. significant ongoing medical problems (e.g., diabetes),

3. history of head injury or seizure,

4. serious psychiatric illness outside of drug use (e.g., schizophrenia),

5. recent use of any agent that inhibits or induces cytochrome P450 3A4 or 2D6,

6. 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,

7. have a cardiac conduction or blood clotting disorder,

8. blood donation within the past 30 days prior to screening,

9. clinically significant laboratory results (as judged by the investigator/sub-investigator)

10. moderate to severe COPD,

11. renal impairment, and

12. severe renal hepatic impairment.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic profiles for each medication/tracer (assayed from blood and urine samples) and will include parameters such as AUC, CMAX, TMax, and t1/2. 26 days
See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain