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

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Treatments: Acetazolamide; Analgesics, Opioid; Pregabalin; Quinine; Riboflavin

Criteria

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.