Buprenorphine Combination Tablet Feasibility - 1 | NCT00000298

Studies
Buprenorphine Combination Tablet Feasibility - 1

NCT00000298

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Aug 17, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine/naloxone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50-09260-1

Status Module

Record Verification Date

Jan 1996

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1995

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 20, 1999

First Submission Date that Met QC Criteria

Sep 20, 1999

First Posted Date

Sep 21, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2005

Last Update Posted Date

Aug 17, 2005Estimated

Description Module

Brief Summary

The purpose of this study is to determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence."

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine/naloxone	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males/Females ages 21-50, opiate dependence according to DSM-IV criteria, self-reported use within the last 30 days, agreeable to conditions of study and signed informed consent

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walter Ling, M.D.	Friends Research Institute, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Friends Research Institute		Los Angeles	California	90025	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Buprenorphine/nalaxone cmbination tablet: First clinical experience (j. Add Dis 1997, in press). Buprenorphine/naloxone combination tablet: First clincial experience (J Add Dis 1997, in press).

Measure	Description	Time Frame
Withdrawal symptoms
Opiate use
Opiate craving

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D002047	Buprenorphine
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids