Mindfulness Training Plus Oxytocin Effects on Smoking Behavior

NCT ID: NCT03819231

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2023-12-31

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.

Conditions

Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness and intranasal oxytocin

Given oxytocin through intranasal administration and self-directed mindfulness training.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: 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.

Mindfulness

Intervention Type: 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.

Mindfulness and placebo

Given sterile saline through intranasal adminstration and self-directed mindfulness training.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: 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

Intervention Type: 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 and placebo

Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.

Group Type: SHAM_COMPARATOR

Saline Solution

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

David Black

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Kirkpatrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS-17-00972

Identifier Type: -

Identifier Source: org_study_id