NCT03819231

Mindfulness Training Plus Oxytocin Effects on Smoking Behavior

Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.

Detailed description

Mindfulness training allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women. In this study, the use oxytocin is experimental and is in the form of a nasal spray.

Conditions

• Smoking
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Oxytocin	A single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) will be self-administered to each participant. Each 40 IU dose will be transferred into four, 1 ml intranasal atomizers and will be administered in four sprays to each nostril over the course of 15 minutes.
BEHAVIORAL	Mindfulness	Participants will be instructed to listen to and practice a 20-minute guided mediation each day for 7 days prior to the experimental session. The guided mindfulness practices will include body scan and seated stillness meditations.
DRUG	Saline Solution	A single 40mL doses of sterile saline (0.9% provided by USC pharmacy) will be transferred into four, 1 ml intranasal atomizers and will be self-administered in four sprays to each nostril over the course of 15 minutes.
BEHAVIORAL	Sham mindfulness	The mindfulness sham group will be required to listen to 20-minutes of Tedtalk podcasts each day that match the attention and time of the mindfulness group. Participants will be instructed to listen to two 10-minutes segments per day in succession between lab visits while in a seated posture.

Timeline

• Start date: 2018-10-10
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-01-28
• Last updated: 2024-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study