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

NCT00015041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

  • Opioid-Related Disorders
  • Substance-Related Disorders

Interventions

DRUG

Buprenorphine

Sponsors & Collaborators

  • Cincinnati MDRU

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Eugene Somoza, M.D., Ph.D. · Cincinnati MDRU

Study Design

Purpose
TREATMENT

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-11-30
Primary Completion
1998-06-30
Completion
1998-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00015041 on ClinicalTrials.gov