Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000320
• Other study ID #: NIDA-10068-1
• Secondary ID: R01-10068-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: October 1997
• Est. completion date: August 1999

Study information

• Verified date: January 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

Description:

1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1999
• Est. primary completion date: August 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine formulation: liquid vs. tablet
random assignment to liquid buprenorphine or tablet buprenorphine

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood level		across study duration	Yes
Secondary	drug use		across study duration	Yes
Secondary	craving		across study duration	Yes
Secondary	withdrawal symptoms		across study duration	Yes