Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Cincinnati MDRU
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00015041

Purpose

The purpose of this study is to evaluate the effect, pharmacokinetics and dose proportionality of buprenorphine when administered to non-dependent opiate users. 1) To evaluate whether plasma concentrations of buprenorphine increase proportionally to buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects of buprenorphine; and 3) To determine the safety of buprenorphine.

Condition	Intervention	Phase
Opioid-Related Disorders Substance-Related Disorders	Drug: Buprenorphine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
Official Title:	PK 0396 - Buprenorphine Dose Escalation Trial

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

PK parameters of buprenorphine
Intoxication and withdrawal

Estimated Enrollment:	0
Study Start Date:	November 1996

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.

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015041

Locations

United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Cincinnati MDRU

Investigators

Principal Investigator:

Eugene Somoza, M.D., Ph.D.

Cincinnati MDRU

More Information

No publications provided

Study ID Numbers:	NIDA-5-0012-2, Y01-5-0012-2
Study First Received:	April 18, 2001
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00015041 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Disease
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Pathologic Processes
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010