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Effects of Intranasal Oxytocin on Cigarette Smoking

NCT ID: NCT02595749

Last Updated: 2021-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nicotine Dependence Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo then Intranasal Oxytocin (40 IU)

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.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Intranasal Oxytocin (40 IU) then Placebo

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.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Oxytocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Pitocin Ocean Spray saline spray

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Matthew Kirkpatrick

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Kirkpatrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC Health, Emotion and Addiction Laboratory

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HS-15-00657

Identifier Type: -

Identifier Source: org_study_id