- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00015041
Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2
PK 0396 - Buprenorphine Dose Escalation Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This will be an open-label, single dose-escalation trial. A total of 24 opiate experienced, but not dependent subjects will receive four ascending doses of buprenorphine, 4, 8, 16, and 24 mg, respectively, with an at least a 14 day washout interval between treatments. The four treatments are sublingual administration of:
- two 2-mg buprenorphine sublingual tablets,
- one 8-mg buprenorphine sublingual tablet,
- two 8-mg buprenorphine sublingual tablets; and
- three 8-mg buprenorphine sublingual tablets.
The dose proportionality in plasma profiles of buprenorphine and dose response of the buprenorphine sublingual tablets are evaluated at buprenorphine dose range of 4 to 24 mg.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Cincinnati MDRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be male or female of any race, between 21 and 45 years of age.
- Weigh within 15% of ideal body weight for height according to the current life insurance table.
- Be in good physical and mental health as judged by interview and physical examination.
- Have no significant oral cavity pathology including excessive caries, gingivitis, infectious or inflammatory disease, or recent piercing of the oral cavity.
- Be experienced in illicit use of opiates but not be physically dependent on opiates and other drugs (except nicotine or caffeine) at the time of the study. A history of other psychoactive drug use is acceptable but preference will be for subjects reporting less frequent and more controlled illicit drug use.
- For female subjects, test nonpregnant and use adequate birth control, and not be lactating.
- Be capable of providing written informed consent to participate in this study.
- Be able to comply with protocol requirements and be likely to complete all four study treatments.
Exclusion Criteria:
- Have a diagnosis of drug addiction (other than nicotine, caffeine, and opiate) as per DSM-IV criteria.
- Have any significant, active medical or psychiatric illnesses (other than drug dependence) which might inhibit their ability to complete the study or might be complicated by administration of study medications.
- Have clinically significant abnormal laboratory measurements in liver function tests (AST and ALT levels greater than 3 times the upper limit of normal), hematology (CBC, differential, platelet count), serum chemistries (SMA-24) and urinalysis at screening.
- Test positive on the HIV blood screen.
- Have a history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorders.
- Have known hypersensitivity to buprenorphine and its derivatives or opiates or opiate-like analgesics.
- Receive any medications for medical conditions.
- Have any condition or history considered by the investigator(s) to place the subjects at increased risk.
- Do not actively meet the inclusion criteria at the time of screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
PK parameters of buprenorphine
|
Intoxication and withdrawal
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eugene Somoza, M.D., Ph.D., Cincinnati MDRU
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Disease
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
Other Study ID Numbers
- NIDA-5-0012-2
- Y01-5-0012-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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