Lofexidine for Opiate Withdrawal - 1 - Full Text View

Lofexidine for Opiate Withdrawal - 1

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Britannia Pharmaceuticals, Ltd.
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00032942

Purpose

The purpose of this study is to evaluate lofexidine for opiate withdrawal.

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: Lofexidine	Phase III

Drug Information available for:

Lofexidine Lofexidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal

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

Primary Outcome Measures:

Opiate withdrawal symptoms
Potential Abuse Liability

Estimated Enrollment:	66
Study Start Date:	April 2001
Estimated Study Completion Date:	December 2002
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Detailed Description:

An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female as least 18 yrs of age & above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.

Exclusion Criteria:

Additional criteria available during screening at the site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032942

Locations


United States, California
	UCLA Medical Center
	Los Angeles, California, United States, 90095

United States, New York
	Columbia University
	New York, New York, United States, 10023

United States, Pennsylvania
	Philadelphia Veterans Medical Center
	Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Britannia Pharmaceuticals, Ltd.

Investigators


Principal Investigator:	Ann Montgomery, R.N.	National Institute on Drug Abuse (NIDA)

More Information

Responsible Party:	National Institute on Drug about ( Ann Montgomery )
Study ID Numbers:	NIDA-CSP-1020-1
First Received:	April 5, 2002
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00032942
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Lofexidine

Opioid-Related Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents

Adrenergic alpha-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Narcotic Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Adrenergic Agonists

Sensory System Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008