Lofexidine for Opiate Withdrawal - 1

This study has been completed.

First Received: April 5, 2002 Last Updated: July 21, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	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

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

Resource links provided by NLM:

Drug Information available for: Lofexidine hydrochloride Lofexidine

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Cardiovascular Agents
Opioid-Related Disorders
Lofexidine

Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009