Lofexidine for Opiate Withdrawal - 1

This study has been completed.
Sponsor:
Collaborator:
Britannia Pharmaceuticals Ltd.
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00032942
First received: April 5, 2002
Last updated: July 21, 2008
Last verified: July 2008
  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-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.

  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
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, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: April 5, 2002
Last Updated: July 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Lofexidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014