Buprenorphine Combination Tablet Feasibility - 1 - Tabular View

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Buprenorphine Combination Tablet Feasibility - 1

This study has been completed.

Study NCT00000298. Last updated on August 16, 2005. Information provided by National Institute on Drug Abuse (NIDA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Buprenorphine Combination Tablet Feasibility - 1

Official Title ^†

Buprenorphine Combination Tablet Feasibility

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Double-Blind, Placebo Control

Primary Outcome Measure ^†

Withdrawal symptoms
Opiate use
Opiate craving

Secondary Outcome Measure ^†

Condition ^†

Opioid-Related Disorders

Intervention ^†

Drug: Buprenorphine/naloxone

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

August 1995

Completion Date

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.

Gender

Both

Ages

21 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00000298

Organization ID

NIDA-09260-1

Secondary IDs ^††

P50-09260-1

Study Sponsor ^†

National Institute on Drug Abuse (NIDA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 1996

First Received Date ^†

September 20, 1999

Last Updated Date

August 16, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.