Status:
COMPLETED
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
Lead Sponsor:
USWM, LLC (dba US WorldMeds)
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Acute Opioid Withdrawal Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting op...
Detailed Description
This is a Phase 3, two-part, multicenter study to evaluate the dose-response, efficacy, and safety of lofexidine in alleviation of symptoms in subjects undergoing total and abrupt withdrawal from shor...
Eligibility Criteria
Inclusion
- Male or female at least 18 years of age.
- Currently dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.) \[17, 18\], on any opioid with a half-life similar to heroin or morphine, including Vicodin®, Lortab®, Lorcet®, Percocet®, Percodan®, Tylox®, or Hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected or swallowed after chewing).
- Seeking treatment for opioid dependence.
- Score of ≥2 on the Objective Opiate Withdrawal Scale (OOWS-Handelsman) at Baseline.
- Reported use of heroin, morphine, or any opioid with a half-life similar to heroin or morphine for at least 21 of the past 30 days.
- Urine toxicology screen positive for opioids but negative for methadone and buprenorphine.
- Females of childbearing potential must agree to using birth control methods and must have had documented proof.
- Able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, and pass the study consent quiz with 100% accuracy (if necessary, quiz may be administered more than one time).
Exclusion
- Female subject who is pregnant or lactating.
- Self-reported use of methadone or buprenorphine in the past 14 days.
- Serious medical illnesses including, but not limited to: seizures, pancreatic disease, liver disease, exposure to a hepatitis virus, and positive hepatitis results.
- Psychiatric disorder, based on the M.I.N.I., including but not limited to dementia or any disorder that, in the opinion of the study physician requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult.
- 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.
- Abnormal cardiovascular exam at screening and before randomization, including any of the following: clinically significant abnormal electrocardiogram (ECG) (e.g., second or third degree heart block, uncontrolled arrhythmia, or QTcF interval greater than 450 msec for males and greater than 470 msec for females); heart rate less than 55 bpm or symptomatic bradycardia; systolic blood pressure (SBP) less than 95 mmHg or symptomatic hypotension; diastolic blood pressure (DBP) less than 65 mmHg; blood pressure (BP) greater than 155/95 mmHg; and prior history of myocardial infarction.
- Clinically significant abnormal laboratory values.
- Requiring any of the following medications currently or within the past 4 weeks: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics (excluding those listed in inclusion criterion #2 above), anticonvulsants, antihypertensives, antiarrhythmics, antiretroviral, and cholesterol lowering medications. Nicotine replacement therapy (patch, inhaler, gum, or nasal spray) will be allowed for nicotine-dependent subjects. Note: Use of a short-acting benzodiazepine (e.g., oxazepam) for insomnia during Days 8 14 will not disqualify a subject.
- Currently dependent (based on the M.I.N.I.) on any psychoactive substance (other than that listed in inclusion criterion #2, caffeine or nicotine) that requires detoxification.
- Donated blood within the last 8 weeks.
- Participated in an investigational drug study within the past 3 months.
- Has "poor" veins that even a single venipuncture cannot be obtained during screening.
- Active tuberculosis (positive tuberculin test and/or confirmatory diagnostic chest x-ray).
- Active syphilis.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT01863186
Start Date
June 1 2013
End Date
December 1 2014
Last Update
March 22 2022
Active Locations (18)
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1
Clovis, California, United States, 93611
2
Escondido, California, United States, 92025
3
San Diego, California, United States
4
Miami, Florida, United States, 33136