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Lofexidine for Opiate Withdrawal - 1

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. Identifier: NCT00032942
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
Britannia Pharmaceuticals Ltd.
Information provided by:
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Lofexidine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 66 participants
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
Study Start Date : April 2001
Actual Primary Completion Date : October 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Opiate withdrawal symptoms
  2. Potential Abuse Liability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00032942

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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.
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Principal Investigator: Ann Montgomery, R.N. National Institute on Drug Abuse (NIDA)
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Responsible Party: Ann Montgomery, National Institute on Drug about Identifier: NCT00032942    
Obsolete Identifiers: NCT00007566, NCT00024713
Other Study ID Numbers: NIDA-CSP-1020-1
First Posted: April 8, 2002    Key Record Dates
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:
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Opioid-Related Disorders
Narcotic-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