Expired Study
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Los Angeles, California 90025


Purpose:

The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.


Criteria:

Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.


Study is Available At:


Original ID:

NIDA-3-0010-6


NCT ID:

NCT00000341


Secondary ID:

Y01-3-0010-6


Study Acronym:


Brief Title:

Evaluation of Liquid vs. Tablet Buprenorphine - 6


Official Title:

Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

1


Enrollment Type:


Overall Contact Information

Official Name:Walter Ling, M.D.
Principal Investigator
Friends Research Institute, Inc.

Study Dates

Start Date:August 1996
Completion Date:August 2000
Completion Type:Actual
Verification Date:August 2008
Last Changed Date:January 11, 2017
First Received Date:September 20, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Subjective and observer rater physiological effects of bup
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Buprenorphine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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