Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000320

Purpose

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."

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: Buprenorphine formulation: liquid vs. tablet	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

blood level [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

drug use [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
craving [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
withdrawal symptoms [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	October 1997
Study Completion Date:	August 1999
Primary Completion Date:	August 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1; liquid formulation liquid formulation	Drug: Buprenorphine formulation: liquid vs. tablet random assignment to liquid buprenorphine or tablet buprenorphine Other Names: Subutex Suboxone
Active Comparator: 2; tablet formulation tablet formulation	Drug: Buprenorphine formulation: liquid vs. tablet random assignment to liquid buprenorphine or tablet buprenorphine Other Names: Subutex Suboxone

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000320

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

No publications provided

Responsible Party:	Walter Ling, M.D., Friends Research Institute
ClinicalTrials.gov Identifier:	NCT00000320 History of Changes
Other Study ID Numbers:	NIDA-10068-1, R01-10068-1
Study First Received:	September 20, 1999
Last Updated:	January 5, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on February 12, 2012