Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
286 participants
INTERVENTIONAL
2015-02-28
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label Lofexidine
During this open-label study, subjects will be given the option to receive lofexidine tablets for 7 days and up to 14 days if requested.
Lofexidine
All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Interventions
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Lofexidine
All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
* Must have current dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.), on any opioid (including methadone and buprenorphine maintenance treatment)
* Must be seeking treatment for partial or total withdrawal from current opioid and expected, as determined by the Principal Investigator, to benefit from lofexidine treatment for at least 7 days at clinically relevant doses. This can include a variety of clinical situations where opioid withdrawal illness is likely to occur including abrupt and total withdrawal (including from methadone and buprenorphine), agonist-assisted total withdrawal, dose reduction of maintenance treatment (e.g., methadone, buprenorphine) and transition from an opioid agonist to naltrexone or buprenorphine maintenance
* Must have Urine toxicology screen result of positive for opioid(s) relevant to the subject's withdrawal treatment goal
* If female and of childbearing potential, subject must agree to use of one of the following methods of birth control including oral contraceptives, patch, barrier (diaphragm, sponge or condom) plus spermicidal preparations, intrauterine contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring or surgical sterilization or partner sterile (with documented proof)
Exclusion Criteria
* History of very serious medical illness not under control including, but not limited to, active self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks and/or having an unstable psychiatric condition. These conditions will be determined at Screening by medical history, physical examination, 12 lead electrocardiogram (duplicate), clinical laboratory tests for infectious diseases, and a tuberculin test
* Current dependence (based on the M.I.N.I.) on any psychoactive substance (excluding caffeine, nicotine, and the subject's current opioid-dependence agent, which can include methadone and buprenorphine, for example, in agonist-maintained subjects) that requires detoxification or dose reduction as part of the pre-defined individual subject withdrawal treatment goal
* Have participated in an investigational drug study within the past 30 days
* Have a history of lofexidine exposure in a prior clinical trial or otherwise
* Have an abnormal cardiovascular exam at screening
* Any subject that requires tricyclic antidepressants, which may reduce the efficacy of imidazoline derivatives and/or beta-receptor blockers, to avoid the risk of excessive bradycardia
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
USWM, LLC (dba US WorldMeds)
INDUSTRY
Responsible Party
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Principal Investigators
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Charles W Gorodetzky, MD, PhD
Role: STUDY_DIRECTOR
US WorldMeds
Locations
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Little Rock, Arkansas, United States
Springdale, Arkansas, United States
San Diego, California, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Winfield, Illinois, United States
Lake Charles, Louisiana, United States
Rockville, Maryland, United States
Flowood, Mississippi, United States
St Louis, Missouri, United States
New York, New York, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
North Charleston, South Carolina, United States
Orem, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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USWM-LX1-3003-2
Identifier Type: -
Identifier Source: org_study_id
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