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

NCT00015041 | Completed Phase 1

• 2 other identifiers: NIDA-5-0012-2Y01-5-0012-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Keywords

opiate dependence

Outcome Measures

Primary Outcomes (2)

• PK parameters of buprenorphine

• Intoxication and withdrawal

Interventions

Buprenorphine DRUG

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Cincinnati MDRU: collaborator

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Eugene Somoza, M.D., Ph.D.

  Cincinnati MDRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 18, 2001
• First Posted: April 18, 2001
• Study Start: November 1, 1996
• Primary Completion: June 1, 1998
• Study Completion: July 1, 1998
• Last Updated: January 12, 2017

Record last verified: 1998-07

Locations

US (1)