Mindfulness Training Plus Oxytocin Effects on Smoking Behavior

Phase 2

Terminated

• Conditions: Smoking; Smoking Cessation
• Interventions: Drug: Oxytocin; Behavioral: Mindfulness; Drug: Saline Solution; Behavioral: Sham mindfulness

• Registration Number: NCT03819231
• Lead Sponsor: University of Southern California

Brief 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.

Study Timeline

• Study Start: 2018-10-10
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Mindfulness and intranasal oxytocin	Oxytocin	Given oxytocin through intranasal administration and self-directed mindfulness training.
Mindfulness and intranasal oxytocin	Mindfulness	Given oxytocin through intranasal administration and self-directed mindfulness training.
Mindfulness and placebo	Mindfulness	Given sterile saline through intranasal adminstration and self-directed mindfulness training.
Mindfulness and placebo	Saline Solution	Given sterile saline through intranasal adminstration and self-directed mindfulness training.
Sham mindfulness and placebo	Saline Solution	Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.
Sham mindfulness and placebo	Sham mindfulness	Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Diastolic blood pressure	Throughout study completion, an average of two weeks.
Heart rate	Throughout study completion, an average of two weeks.
Systolic blood pressure	Throughout study completion, an average of two weeks.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States