We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness Training Plus Oxytocin (MOXY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819231
Recruitment Status : Suspended (Study recruitment temporarily suspended due to COVID-19 pandemic.)
First Posted : January 28, 2019
Last Update Posted : November 2, 2022
Sponsor:
Collaborator:
MGM Foundation
Information provided by (Responsible Party):
David Black, 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. 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.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Drug: Oxytocin Behavioral: Mindfulness Drug: Saline Solution Behavioral: Sham mindfulness Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Mindfulness and intranasal oxytocin
Given oxytocin through intranasal administration and self-directed mindfulness training.
Drug: Oxytocin
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.

Behavioral: Mindfulness
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.
Behavioral: Mindfulness
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.

Drug: Saline 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.

Sham Comparator: Sham mindfulness and placebo
Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.
Drug: Saline 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.

Behavioral: Sham 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.




Primary Outcome Measures :
  1. Smoking Lapse Analogue Task (delay score) [ Time Frame: 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).

  2. Trier Social Stress Test [ Time Frame: 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 :
  1. Systolic blood pressure [ Time Frame: Throughout study completion, an average of two weeks. ]
  2. Diastolic blood pressure [ Time Frame: Throughout study completion, an average of two weeks. ]
  3. Heart rate [ Time Frame: Throughout study completion, an average of two weeks. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819231


Locations
Layout table for location information
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
MGM Foundation
Layout table for additonal information
Responsible Party: David Black, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03819231    
Other Study ID Numbers: HS-17-00972
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Black, University of Southern California:
Mindfulness
Oxytocin
Additional relevant MeSH terms:
Layout table for MeSH terms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs