Mindfulness Training Plus Oxytocin Effects on Smoking Behavior (MOXY)

University of Southern California

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Smoking; Smoking Cessation

Treatments: Drug: Saline Solution; Behavioral: Sham mindfulness; Drug: Oxytocin; Behavioral: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT03819231

HS-17-00972

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Mindfulness and intranasal oxytocin

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness

Drug: Oxytocin

Mindfulness and placebo

Active Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness

Drug: Saline Solution

Sham mindfulness and placebo

Sham Comparator group

Description:

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

Treatment:

Behavioral: Sham mindfulness

Drug: Saline Solution