Evaluation of a Compliance Marker in Prescription Opioid Abusers With Chronic Pain

NCT02276989 | Withdrawn Phase 2 DMC

• 1 other identifier: 2013-0751
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Compliance; Chronic Pain

Keywords

Chronic Pain; Compliance Marker; Narcotic Abuse; Opioid related disorders; Opiate substitution treatment; Buprenorphrine; Suboxone; Lyrica; Pregabalin; Acetazolamide; Quinine; Compliance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Compliance Intervention

EXPERIMENTAL

Subjects will receive acetazolamide, quinine and riboflavin as experimental compliance markers and will serve as their own controls.

Drug: acetazolamide; Drug: Quinine; Drug: Riboflavin

Interventions

acetazolamide DRUG

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.

Also known as: ACZ

Compliance Intervention

Quinine DRUG

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.

Also known as: QUIN

Compliance Intervention

Riboflavin DRUG

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.

Also known as: Vitamin B2

Compliance Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Patient Compliance; Chronic Pain; Narcotic-Related Disorders; Opioid-Related Disorders

Interventions

Acetazolamide; Quinine; Riboflavin

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavins; Pteridines; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Peggy Compton, RN, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (1)