Mindfulness Training Plus Oxytocin Effects on Smoking Behavior

NCT03819231 | Terminated Phase 2 FDA Drug

• 1 other identifier: HS-17-00972
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.

Conditions

Smoking; Smoking Cessation

Keywords

Mindfulness; Oxytocin

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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.

Study Arms (3)

Mindfulness and intranasal oxytocin

EXPERIMENTAL

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

Drug: Oxytocin; Behavioral: Mindfulness

Mindfulness and placebo

ACTIVE COMPARATOR

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

Behavioral: Mindfulness; Drug: Saline Solution

Sham mindfulness and placebo

SHAM COMPARATOR

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

Drug: Saline Solution; Behavioral: Sham mindfulness

Interventions

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.

Mindfulness and intranasal oxytocin

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.

Mindfulness and intranasal oxytocin; Mindfulness and placebo

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.

Mindfulness and placebo; Sham mindfulness and placebo

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.

Sham mindfulness and placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Smoke at least 10 cigarettes per day for the past year

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Oxytocin; Mindfulness; Saline Solution

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Matthew Kirkpatrick, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 28, 2019
• Study Start: October 10, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)