Effects of Intranasal Oxytocin on Cigarette Smoking

Nicotine Dependence Clinical Trial

Official title:

Effects of Intranasal Oxytocin on Cigarette Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595749
• Other study ID #: HS-15-00657
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: October 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Drug:
• Oxytocin

• Placebo

Locations

Country	Name	City	State
United States	USC Health, Emotion and Addiction Laboratory	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (minimum = 0 minutes to maximum = 50 minutes). A higher number is better.	2.5 hours after nasal spray administration
Primary	Brief Questionnaire of Smoking Urges (QSU)	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.	30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Primary	Systolic Blood Pressure (mmHg)	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.	30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Primary	Diastolic Blood Pressure (mmHg)	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.	30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Primary	Heart Rate (Bpm)	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.	30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Secondary	Profile of Mood States (Anxious Scale)	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.	30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray