MOXY: Mindfulness Training Plus Oxytocin

Sponsor

University of Southern California (Other)

Overall Status

Recruiting

CT.gov ID

NCT03819231

Collaborator

MGM Foundation (Other)

180

Enrollment

Location

Arms

62.7

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Smoking Cessation	Drug: Oxytocin Behavioral: Mindfulness Drug: Saline Solution Behavioral: Sham mindfulness	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 10, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness and intranasal oxytocin Given oxytocin through intranasal administration and self-directed mindfulness training.	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.
Active Comparator: Mindfulness and placebo Given sterile saline through intranasal adminstration and self-directed mindfulness training.	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.
Sham Comparator: Sham mindfulness and placebo Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.	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.

Arm

Intervention/Treatment

Experimental: Mindfulness and intranasal oxytocin

Given oxytocin through intranasal administration and self-directed mindfulness training.

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.

Active Comparator: Mindfulness and placebo

Given sterile saline through intranasal adminstration and self-directed mindfulness training.

Behavioral: Mindfulness

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.

Sham Comparator: Sham mindfulness and placebo

Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.

Drug: Saline Solution

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.

Outcome Measures

Primary Outcome Measures

Smoking Lapse Analogue Task (delay score) [2 hours after nasal spray administration]
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).
Trier Social Stress Test [1 hour after nasal spray administration]
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.

Secondary Outcome Measures

Systolic blood pressure [Throughout study completion, an average of two weeks.]
Diastolic blood pressure [Throughout study completion, an average of two weeks.]
Heart rate [Throughout study completion, an average of two weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

University of Southern California
MGM Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Black, Assistant Professor, University of Southern California

ClinicalTrials.gov Identifier:

NCT03819231

Other Study ID Numbers:

HS-17-00972

First Posted:

Jan 28, 2019

Last Update Posted:

Jan 28, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Black, Assistant Professor, University of Southern California

Mindfulness

Oxytocin

Additional relevant MeSH terms:

Oxytocin

Study Results

No Results Posted as of Jan 28, 2019