This phase II trial studies the effect of mindfulness training and oxytocin in reducing smoking and craving among smokers in withdrawal. Mindfulness training given in the form of daily audio recordings allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment. Oxytocin is a naturally occurring hormone in the brain and throughout the body. Increasing oxytocin level in the body may reduce tobacco craving. This trial is being done to learn if mindfulness training combined with oxytocin nasal spray reduces the urge to smoke.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03819231.
PRIMARY OBJECTIVES:
I. To test the effects of mindfulness training (MT) combined with intranasal oxytocin (inOT) on the ability to resist smoking on the smoking lapse task following exposure to an acute social evaluative stressor.
II. To test the effects of MT combined with inOT on smoking urge, nicotine withdrawal, anxiety and cortisol levels following exposure to an acute social evaluative stressor.
EXPLORATORY OBJECTIVE:
I. To test potential psychophysiological mechanisms of action linking MT and smoking behavior.
OUTLINE:
PILOT: Participants are assigned to 1 of 2 groups.
PILOT GROUP I: Participants listen to and practice a 20-minute guided meditation daily for 7 days.
PILOT GROUP II: Participants complete sham MT of Tedtalk over 20 minutes daily for 7 days.
MAIN STUDY: Participants are randomized to 1 of 4 groups:
GROUP I: Participants listen to and practice a 20-minute guided meditation daily for 14 days. Participants also receive inOT via nasal spray for 4 doses over 15 minutes.
GROUP II: Participants listen to and practice a 20-minute guided meditation daily for 14 days. Participants also receive placebo via nasal spray for 4 doses over 15 minutes.
GROUP III: Participants complete sham MT of Tedtalk over 20 minutes daily for 14 days and receive inOT via nasal spray for 4 doses over 15 minutes.
GROUP IV: Participants complete sham MT of Tedtalk over 20 minutes daily for 14 days and receive placebo via nasal spray for 4 doses over 15 minutes.
Lead OrganizationUSC / Norris Comprehensive Cancer Center
Principal InvestigatorDavid Black