Clinical trial NCT02595749: Effects of Intranasal Oxytocin on Cigarette Smoking
Official title: Effects of Intranasal Oxytocin on Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
Tobacco Smoking
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Smoking Lapse Analogue Task (Delay Score)
timeFrame: 2.5 hours after nasal spray administration
measure: Brief Questionnaire of Smoking Urges (QSU)
timeFrame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
measure: Systolic Blood Pressure (mmHg)
timeFrame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
measure: Diastolic Blood Pressure (mmHg)
timeFrame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
measure: Heart Rate (Bpm)
timeFrame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Secondary outcomes:
measure: Profile of Mood States (Anxious Scale)
timeFrame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Health, Emotion and Addiction Laboratory
state: California
Study officials:
affiliation: University of Southern California
name: Matthew Kirkpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
References: