- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819231
Mindfulness Training Plus Oxytocin (MOXY)
October 28, 2022 updated by: David Black, University of Southern California
Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Los Angeles, California, United States, 90033
- University of Southern California
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness and intranasal oxytocin
Given oxytocin through intranasal administration and self-directed mindfulness training.
|
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.
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.
|
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.
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.
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Sham Comparator: Sham mindfulness and placebo
Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Lapse Analogue Task (delay score)
Time Frame: 2 hours after nasal spray administration
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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).
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2 hours after nasal spray administration
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Trier Social Stress Test
Time Frame: 1 hour after nasal spray administration
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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.
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1 hour after nasal spray administration
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systolic blood pressure
Time Frame: Throughout study completion, an average of two weeks.
|
Throughout study completion, an average of two weeks.
|
Diastolic blood pressure
Time Frame: Throughout study completion, an average of two weeks.
|
Throughout study completion, an average of two weeks.
|
Heart rate
Time Frame: Throughout study completion, an average of two weeks.
|
Throughout study completion, an average of two weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2018
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
January 16, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 28, 2019
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-17-00972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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