Mindfulness Training Plus Oxytocin

Study Overview
=================
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.

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

Conditions
-----------------
Smoking, Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Behavioral: Mindfulness
* Drug: Saline Solution
* Behavioral: Sham mindfulness


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness and intranasal oxytocin<br>Given oxytocin through intranasal administration and self-directed mindfulness training. | Drug: Oxytocin<br>* 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.<br>Behavioral: Mindfulness<br>* 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.<br>|
| Active Comparator: Mindfulness and placebo<br>Given sterile saline through intranasal adminstration and self-directed mindfulness training. | Behavioral: Mindfulness<br>* 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.<br>Drug: Saline Solution<br>* 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.<br>|
| Sham Comparator: Sham mindfulness and placebo<br>Given sterile saline through intranasal adminstration and sham self-directed mindfulness training. | Drug: Saline Solution<br>* 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.<br>Behavioral: Sham mindfulness<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Oxytocin