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Study completed early due to COVID-19 pandemic regulations.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness and intranasal oxytocin | Experimental | Given oxytocin through intranasal administration and self-directed mindfulness training. |
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| Mindfulness and placebo | Active Comparator | Given sterile saline through intranasal adminstration and self-directed mindfulness training. |
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| Sham mindfulness and placebo | Sham Comparator | Given sterile saline through intranasal adminstration and sham self-directed mindfulness training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 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. |
| 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 |
| 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. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Kirkpatrick, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D064866 | Mindfulness |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Mindfulness | Behavioral | 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. |
|
| Saline Solution | Drug | 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 mindfulness | Behavioral | 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. |
|
| Heart rate |
| Throughout study completion, an average of two weeks. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |