Effects of Intranasal Oxytocin on Cigarette Smoking

Status

Completed

Phase

Phase 4

Enrollment

83 participants (actual)

Sponsor

University of Southern California · Other

Design

Randomized · Double masking

Countries

1 country

United States

Start

Jul 2016

Primary completion

Jul 2019

Completion

Jul 2019

First posted

3 Nov 2015 (estimated)

Last update posted

15 Nov 2021

Conditions

Nicotine Dependence · Tobacco Smoking

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.

• Experimental

  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.

• Experimental

  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.

1. Smoking Lapse Analogue Task (Delay Score)

   Time frame · 2.5 hours after nasal spray administration

   Registry 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.

2. Brief Questionnaire of Smoking Urges (QSU)

   Time frame · 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

   Registry 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.

3. Systolic Blood Pressure (mmHg)

   Time frame · 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

   Registry 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.

4. Diastolic Blood Pressure (mmHg)

   Time frame · 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

   Registry 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.

5. Heart Rate (Bpm)

   Time frame · 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray

   Registry 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.

No study cites this trial.