Smoking, Smoking Cessation
Conditions
Keywords
Mindfulness, Oxytocin
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.
Interventions
DRUGOxytocin
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.
BEHAVIORALMindfulness
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.
DRUGSaline 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.
BEHAVIORALSham 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.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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. |
Countries
United States
Outcome results
None listed