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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00015041
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 12, 2017
Cincinnati MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: Buprenorphine Phase 1

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:

  1. two 2-mg buprenorphine sublingual tablets,
  2. one 8-mg buprenorphine sublingual tablet,
  3. two 8-mg buprenorphine sublingual tablets; and
  4. 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: PK 0396 - Buprenorphine Dose Escalation Trial
Study Start Date : November 1996
Primary Completion Date : June 1998
Study Completion Date : July 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. PK parameters of buprenorphine
  2. Intoxication and withdrawal

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be male or female of any race, between 21 and 45 years of age.
  2. Weigh within 15% of ideal body weight for height according to the current life insurance table.
  3. Be in good physical and mental health as judged by interview and physical examination.
  4. Have no significant oral cavity pathology including excessive caries, gingivitis, infectious or inflammatory disease, or recent piercing of the oral cavity.
  5. 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.
  6. For female subjects, test nonpregnant and use adequate birth control, and not be lactating.
  7. Be capable of providing written informed consent to participate in this study.
  8. Be able to comply with protocol requirements and be likely to complete all four study treatments.

Exclusion Criteria:

  1. Have a diagnosis of drug addiction (other than nicotine, caffeine, and opiate) as per DSM-IV criteria.
  2. 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.
  3. 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.
  4. Test positive on the HIV blood screen.
  5. Have a history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorders.
  6. Have known hypersensitivity to buprenorphine and its derivatives or opiates or opiate-like analgesics.
  7. Receive any medications for medical conditions.
  8. Have any condition or history considered by the investigator(s) to place the subjects at increased risk.
  9. Do not actively meet the inclusion criteria at the time of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00015041

United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Cincinnati MDRU
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU Identifier: NCT00015041     History of Changes
Other Study ID Numbers: NIDA-5-0012-2
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 1998

Keywords provided by National Institute on Drug Abuse (NIDA):
opiate dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists