A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With… (NCT00768482) | Clinical Trial Compass
TerminatedPhase 3
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
Stopped: This study was terminated for reasons not related to efficacy or safety
United States9 participantsStarted 2008-09
Plain-language summary
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily provide written informed consent prior to the conduct of any study related procedures
* Male or female, 18-75 years of age
* Meet the DSM-IV criteria for current opioid dependence
* Females of childbearing potential and fertile males must use a reliable means of contraception
Exclusion Criteria:
* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Received treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for only short term opioid treatment or opioid detoxification therapy
* Pregnant or lactating females
* Previous hypersensitivity or allergy to BPN or EVA-containing substances or naloxone
* Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current history of coagulopathy, and/or anti-coagulant therapy (such as warfarin)
* Meet the DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate coope…
What they're measuring
1
Plasma BPN AUC(0-24)during 24 hours at steady state.