Phase 4
N=83
Effects of Intranasal Oxytocin on Cigarette Smoking
Nicotine Dependence · Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02595749 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Smoking Lapse Analogue Task (Delay Score) — 11.5; 10.9 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Lapse Analogue Task (Delay Score) |
11.5; 10.9 | — |
| PRIMARY Brief Questionnaire of Smoking Urges (QSU) |
2.46; 2.49 | — |
| PRIMARY Systolic Blood Pressure (mmHg) |
122.1; 118.2 | — |
| PRIMARY Diastolic Blood Pressure (mmHg) |
77.5; 74.7 | — |
| PRIMARY Heart Rate (Bpm) |
65.6; 65.9 | — |
| SECONDARY Profile of Mood States (Anxious Scale) |
0.82; 0.71 | — |
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
Data sourced from ClinicalTrials.gov (NCT02595749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.