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Sponsors and Collaborators: |
Department of Veterans Affairs National Institute on Drug Abuse (NIDA) US WorldMeds LLC |
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00235729 |
The main objective of this study is to investigate the effectiveness of lofexidine in reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently, lofexidine is the most commonly used non-opiate medication for detoxification from opiates in the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug Administration (FDA) for the same indication in the United States (US). The only medications currently approved by the FDA for opiate detoxification are methadone and buprenorphine. These medications, however, have the potential to be abused. Lofexidine, on the other hand, offers a unique advantage for opiate detoxification because it is not addicting, is easy to use, and has a favorable safety profile.
Condition | Intervention | Phase |
Opiate Addiction |
Drug: Lofexidine Drug: Placebo |
Phase III |
ChemIDplus related topics: | Lofexidine Lofexidine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | CSP #1024 - A Phase III, Randomized, Multi-Center, Double Blind, Placebo-Controlled Study of Safety and Efficacy of Lofexidine for Relief of Symptoms in Subjects Undergoing Inpatient Opiate Detoxification. |
Enrollment: | 264 |
Study Start Date: | June 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Lofexidine 0.8 mg QID
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Drug: Lofexidine |
2: Placebo Comparator
Placebo QID
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Drug: Placebo |
Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Potential subjects must:
If female and of child bearing potential, agree to use of one of the following methods of birth control:
Exclusion Criteria:
Potential subjects must not:
Have serious medical illnesses including, but not limited to:
Have an abnormal cardiovascular exam prior to randomization, including any of the following:
United States, California | |||||
CNS, Cerritos | |||||
Cerritos, California, United States, 90703 | |||||
United States, District of Columbia | |||||
CNS Psychiatric Institute of Washington | |||||
Washington, District of Columbia, United States, 20016 | |||||
United States, Georgia | |||||
Atlanta Center for Medical Research | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, Illinois | |||||
Alexian Center for Psychiatric Research | |||||
Hoffman Estates, Illinois, United States, 60194 | |||||
United States, Kentucky | |||||
University of Kentucky | |||||
Lexington, Kentucky, United States, 40502 | |||||
United States, Maryland | |||||
VA Maryland Health Care System, Baltimore | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, Michigan | |||||
Wayne State University School of Medicine | |||||
Detroit, Michigan, United States, 48207 | |||||
United States, New York | |||||
Richmond Medical Center | |||||
Staten Island, New York, United States, 10304 | |||||
United States, Pennsylvania | |||||
VA Medical Center, Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Rhode Island | |||||
VA Medical Center, Providence | |||||
Providence, Rhode Island, United States, 02908 | |||||
United States, Tennessee | |||||
Psychiatric Hospital at Vanderbilt | |||||
Nashville, Tennessee, United States, 37232-8650 | |||||
United States, Texas | |||||
Research Across America | |||||
Dallas, Texas, United States, 75234 | |||||
University of Texas Health Science Center at San Antonio | |||||
San Antonio, Texas, United States, 78229-3900 | |||||
United States, Utah | |||||
VA Salt Lake City Health Care System, Salt Lake City | |||||
Salt Lake City, Utah, United States, 84148 | |||||
United States, Washington | |||||
VA Puget Sound Health Care System, Seattle | |||||
Seattle, Washington, United States, 98108 | |||||
United States, Wisconsin | |||||
Aurora Psychiatric Hospital | |||||
Wauwatosa, Wisconsin, United States, 53213 |
Department of Veterans Affairs |
National Institute on Drug Abuse (NIDA) |
US WorldMeds LLC |
Study Chair: | Charles W. Gorodetzky | VA Maryland Health Care System, Baltimore |
Responsible Party: | Department of Veterans Affairs ( Gorodetzky, Charles - Study Chair ) |
Study ID Numbers: | 1024, USWM-001 |
First Received: | October 6, 2005 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00235729 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
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