Glucocorticoid Antagonist Treatment for Tobacco Use Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03248713|
Recruitment Status : Terminated (Lack of recruitment)
First Posted : August 14, 2017
Last Update Posted : May 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Mifepristone Drug: Placebo||Early Phase 1|
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 behavior. Once the intake and physical examination is completed and eligibility is determined, subjects will participate in a baseline session to become familiar with the study procedures and to assess baseline measures of withdrawal, smoking urges, pain sensitivity, and cognitive performance. Subjects will be asked to refrain from consuming alcoholic beverages and drugs during their study participation. This will be verified by urine drug screening and breathalyzer before the session and during outpatient visits. If results indicate non-compliance with these study procedures, subjects will be discharged from the study.
Participants will be assessed for compliance with medication treatment, withdrawal severity, recent smoking behavior, and cognitive function during treatment visits on Days 1 and 4. On Day 7, following overnight abstinence from smoking, participants will attend a test session that models relapse to smoking. During this session, subjects will have the option to smoke, or to delay smoking in exchange for monetary compensation (45). To examine if mifepristone's proposed therapeutic effects last beyond the treatment duration (as observed in previous studies), there will be 1-week and 1-month follow-up assessments on smoking behavior, urges to smoke, endocrine biomarkers, and cognitive function.
Participants in each group will complete the laboratory-based, delayed smoking procedure in a designated, negative pressure room in Bldg. 36 of the West Haven VA just after assessing pain sensitivity with the cPT. This sequence allows the cPT to assess pain sensitivity, a potential biomarker of relapse behavior, and to also be used as a mild stressor prior to participation in the smoking relapse model. Participants will be instructed to abstain from smoking after 10 pm the night before Test Sessions. Abstinence will be confirmed the morning of the session by measuring a breath CO level of < 8 ppm.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The primary analyses will use linear mixed models (LMMs). LMMs can handle continuous and dichotomous outcomes, as well as missing data. Analyses will include baseline (pre-treatment) measures of these variables as covariates and other baseline variables where appropriate.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||This is a double blind randomized study|
|Primary Purpose:||Health Services Research|
|Official Title:||Glucocorticoid Antagonist Treatment for Tobacco Use Disorder|
|Actual Study Start Date :||November 29, 2017|
|Actual Primary Completion Date :||May 20, 2019|
|Actual Study Completion Date :||May 20, 2019|
Active Comparator: Mifepristone
Mifepristone 600 mg/day in 2 tablets
Placebo sugar 2 tablets will be compared to mifepristone
Other Name: sugar pill
Placebo Comparator: Placebo
matching placebo in 2 tablets
Mifepristone 600mg 2 tablets will be compared to the placebo
Other Name: korlym, mifeprex
- Minnesota Nicotine Withdrawal Symptom Checklist (M-NWSC) [ Time Frame: one week ]Smokers will be asked to rate several nicotine withdrawal symptoms on a 100 mm scale, from "not at all" to "extremely."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248713
|United States, Connecticut|
|Veterans Affairs Hospital|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D.,Ph.D.||Yale University|