Skip to main content
OpenTrials
Completed

NCT Number: NCT02595749

Effects of Intranasal Oxytocin on Cigarette Smoking

Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural processes that encode, interpret, and respond to socially and emotionally relevant stimuli) have been implicated in tobacco smoking and relapse, however this potential target for medication development has not been systematically examined. Evidence from animal and human laboratories indicate that administration of intranasal oxytocin enhances socioemotional processing and may be efficacious for the treatment of drug addiction, including nicotine dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular smokers following overnight abstinence.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

USC Health, Emotion and Addiction Laboratory

Los Angeles, California, 90032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-40
  • Smoke >= 10 cig/day for the past year
  • English fluency

Exclusion criteria

  • Current DSM-5 substance use disorder, excluding nicotine dependence (to minimize alcohol or drug withdrawal symptoms during the study sessions)
  • Any medical condition that would increase risk for study participation (such as sinus infection or other condition blocking access to the olfactory epithelium)
  • Women who are pregnant or nursing
  • Current use of psychiatric medication
  • Breath Carbon Monoxide (CO) levels < 10ppm measured during study intake (to exclude individuals who overreport smoking in order to participate in the study)
  • Planning to quit or reduce smoking in the next 30 days
  • Current regular use of other nicotine products

Treatment and study plan

Oxytocin

Drug

Other names: Pitocin

Placebo

Drug

Other names: Ocean Spray saline spray

Primary outcomes

  1. Smoking Lapse Analogue Task (Delay Score)

    Time frame: 2.5 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 (minimum = 0 minutes to maximum = 50 minutes). A higher number is better.

  2. Brief Questionnaire of Smoking Urges (QSU)

    Time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

    The Brief Questionnaire of Smoking Urges (QSU) is a 10-item self-report questionnaire measures desire, intention, urge, and need to smoke. The QSU was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Scores at each assessment time are calculated as the mean of all 10 items (minimum = 0 to maximum = 5). Each session's scores are then calculated as the mean scores of post-spray assessments. A lower score is better.

  3. Systolic Blood Pressure (mmHg)

    Time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

    Systolic blood pressure (SP) was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's values are calculated as the mean of post-spray assessments.

  4. Diastolic Blood Pressure (mmHg)

    Time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

    Diastolic blood pressure (DP) was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's values are calculated as the mean of post-spray assessments.

  5. Heart Rate (Bpm)

    Time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

    Heart rate (HR) was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's values are calculated as the mean of post-spray assessments.

Secondary outcomes

  1. Profile of Mood States (Anxious Scale)

    Time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

    The Profile of Mood States (POMS) lists 72 affective adjectives that are rated on 0 to 4-point. The main measure for this study is the Anxious scale, calculated as the mean of 6 anxiety-related items. The POMS was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's scores are calculated as the mean scores of post-spray assessments. Lower scores are better.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2015
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.