Mindfulness Training Plus Oxytocin

Smoking Cessation Clinical Trial

— MOXY  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03819231
• Other study ID #: HS-17-00972
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: October 10, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 180
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Smoke at least 10 cigarettes per day for the past year

Exclusion Criteria:

• Current DSM-5 substance use disorder
• Any medial condition that would increase risk for study participation
• Women who are pregnant or nursing
• Current use of psychiatric medication for anxiety or mood disorders
• Planning to quit or reduce smoking in the next 30 days
• Current regular use of other nicotine-containing products
• Current mindfulness or mediation practice of greater than 5 minutes per day

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	MGM Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Lapse Analogue Task (delay score)	This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (0-50 min).	2 hours after nasal spray administration
Primary	Trier Social Stress Test	This test measures self-reported responses to stress in a lab setting over the course of 30 minutes through salivary cortisol and heart rate variability.	1 hour after nasal spray administration
Secondary	Systolic blood pressure		Throughout study completion, an average of two weeks.
Secondary	Diastolic blood pressure		Throughout study completion, an average of two weeks.
Secondary	Heart rate		Throughout study completion, an average of two weeks.