Status:
WITHDRAWN
Evaluation of a Compliance Marker in Prescription Opioid Abusers With Chronic Pain
Lead Sponsor:
Georgetown University
Conditions:
Compliance
Chronic Pain
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 ...
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 no...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02276989
Start Date
December 1 2014
End Date
January 1 2016
Last Update
February 10 2017
Active Locations (1)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20007