Nicotine Dependence Clinical Trial
Official title:
Glucocorticoid Antagonist Treatment for Tobacco Use Disorder
Verified date | May 2019 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | May 20, 2019 |
Est. primary completion date | May 20, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Hospital | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minnesota Nicotine Withdrawal Symptom Checklist (M-NWSC) | Smokers will be asked to rate several nicotine withdrawal symptoms on a 100 mm scale, from "not at all" to "extremely." | one week |
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