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Lofexidine for Opiate Withdrawal - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00032942
First Posted: April 8, 2002
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Britannia Pharmaceuticals Ltd.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
The purpose of this study is to evaluate lofexidine for opiate withdrawal.

Condition Intervention Phase
Opioid-Related Disorders Drug: Lofexidine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Ann Montgomery, National Institute on Drug about
ClinicalTrials.gov Identifier: NCT00032942     History of Changes
Obsolete Identifiers: NCT00007566, NCT00024713
Other Study ID Numbers: NIDA-CSP-1020-1
First Submitted: April 5, 2002
First Posted: April 8, 2002
Last Update Posted: January 12, 2017
Last Verified: July 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
opiate dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
Clonidine
Lofexidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Narcotic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympatholytics
Autonomic Agents