Glucocorticoid Antagonist Treatment for Tobacco Use Disorder

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

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). Mifepristone has already shown promise as a potential treatment for PTSD (1) and alcohol use disorder (AUD) (2), but no previous studies have examined the therapeutic potential of mifepristone for TUD. This will be a double-blind, placebo-controlled study on the effects of a 7-day treatment with 600 mg mifepristone, or placebo, on cognitive function, tobacco withdrawal severity, and smoking behavior.

Key facts

Study ID: NCT03248713
Run by: Yale University
People needed: 8
Starts: 2017-11-29
Expected to finish: 2019-05-20
Last updated by the study team: 2019-05-28

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Veterans Affairs Hospital — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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