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Lofexidine for Opiate Withdrawal - 1

This study has been completed.
Britannia Pharmaceuticals Ltd.
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 5, 2002
Last updated: January 11, 2017
Last verified: July 2008
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-Blind
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.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00032942

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

Responsible Party: Ann Montgomery, National Institute on Drug about Identifier: NCT00032942     History of Changes
Obsolete Identifiers: NCT00007566, NCT00024713
Other Study ID Numbers: NIDA-CSP-1020-1
Study First Received: April 5, 2002
Last Updated: January 11, 2017

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
Antihypertensive Agents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents processed this record on June 23, 2017