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Effects of Intranasal Oxytocin on Cigarette Smoking

Primary Purpose

Nicotine Dependence, Tobacco Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

  • USC Health, Emotion and Addiction Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo then Intranasal Oxytocin (40 IU)

Intranasal Oxytocin (40 IU) then Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 30, 2015
Last Updated
October 16, 2021
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT02595749
Brief Title
Effects of Intranasal Oxytocin on Cigarette Smoking
Official Title
Effects of Intranasal Oxytocin on Cigarette Smoking
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Tobacco Smoking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo then Intranasal Oxytocin (40 IU)
Arm Type
Experimental
Arm 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.
Arm Title
Intranasal Oxytocin (40 IU) then Placebo
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Ocean Spray saline spray
Primary Outcome Measure Information:
Title
Smoking Lapse Analogue Task (Delay Score)
Description
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.
Time Frame
2.5 hours after nasal spray administration
Title
Brief Questionnaire of Smoking Urges (QSU)
Description
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.
Time Frame
30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Title
Systolic Blood Pressure (mmHg)
Description
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.
Time Frame
30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Title
Diastolic Blood Pressure (mmHg)
Description
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.
Time Frame
30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Title
Heart Rate (Bpm)
Description
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.
Time Frame
30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
Secondary Outcome Measure Information:
Title
Profile of Mood States (Anxious Scale)
Description
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.
Time Frame
30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Kirkpatrick, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Health, Emotion and Addiction Laboratory
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Intranasal Oxytocin on Cigarette Smoking

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