Status:
TERMINATED
Glucocorticoid Antagonist Treatment for Tobacco Use Disorder
Lead Sponsor:
Yale University
Conditions:
Nicotine Dependence
Eligibility:
MALE
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this protocol is to examine whether mifepristone, a medication with glucocorticoid receptor antagonist activity, may be a potential treatment for Tobacco Use Disorder (TUD). Mifepriston...
Detailed Description
This will be a double-blind, placebo-controlled study that tests the effects of a 7-day treatment with 600 mg mifepristone, or placebo, on cognitive function, tobacco withdrawal severity and smoking b...
Eligibility Criteria
Inclusion
- Male smokers aged 18 to 55 years;
- History of smoking at least 5 cigarettes daily for the past 12 months;
- In good health as verified by medical history, screening examination, and -screening laboratory tests
Exclusion
- History of mifepristone allergy;
- Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
- Medical illnesses including diabetes, cardiovascular, renal, endocrine, or hepatic disorders;
- Prolonged QTc interval \>450 msec;
- History of adrenal insufficiency or a morning plasma cortisol level less than 5 mcg/dl at screening;
- Hypokalemia at screening (defined as potassium level \< 3.5 mEq/L);
- Current use of clinically significant CYP 3A4 substrates including, simvastatin, lovastatin, cyclosporine, ergotamines, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, triazolam, midazolam.
- use of rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's Wort.
- Current use of strong 3A4 inhibitors including ketoconazole, itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir, fosamprenivir, boceprevir, clarithromycin, conivaptan, lopinavir, mibefradil, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole.
- Treatment with systemic corticosteroids
- Current use of clinically significant CYP 3A inducers (e.g., rifampin, rifabutin);
- Abuse of alcohol or any other illicit or prescription drugs;
- Inability to tolerate cold exposure due to conditions such as peripheral -vascular disease or Raynaud's phenomenon;
- Inability to fulfill all scheduled visits and examination procedures throughout the study period.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03248713
Start Date
November 29 2017
End Date
May 20 2019
Last Update
May 28 2019
Active Locations (1)
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1
Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516