Effects of Intranasal Oxytocin on Cigarette Smoking

University of Southern California

Status and phase: Completed; Phase 4

Conditions: Nicotine Dependence; Tobacco Smoking

Treatments: Drug: Placebo; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02595749

HS-15-00657

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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83 participants in 2 patient groups

Placebo then Intranasal Oxytocin (40 IU)

Experimental group

Description:

Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.

Treatment:

Drug: Oxytocin

Drug: Placebo

Intranasal Oxytocin (40 IU) then Placebo

Experimental group

Description:

Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.

Treatment:

Drug: Oxytocin

Drug: Placebo