Effects of Intranasal Oxytocin on Cigarette Smoking

NCT02595749 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HS-15-00657
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Tobacco Smoking

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Profile of Mood States (Anxious Scale)

  30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

Study Arms (2)

Placebo then Intranasal Oxytocin (40 IU)

EXPERIMENTAL

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.

Drug: Oxytocin; Drug: Placebo

Intranasal Oxytocin (40 IU) then Placebo

EXPERIMENTAL

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.

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

Also known as: Pitocin

Intranasal Oxytocin (40 IU) then Placebo; Placebo then Intranasal Oxytocin (40 IU)

Placebo DRUG

Also known as: Ocean Spray saline spray

Intranasal Oxytocin (40 IU) then Placebo; Placebo then Intranasal Oxytocin (40 IU)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-40
• Smoke \>= 10 cig/day for the past year
• English fluency

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC Health, Emotion and Addiction Laboratory

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Smoking

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Matthew Kirkpatrick
• Organization: USC Dept. of Preventive Medicine

mgkirkpa@usc.edu

3234428221

Study Officials

• Matthew Kirkpatrick, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: July 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 15, 2021
• Results First Posted: November 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)