Effects of Intranasal Oxytocin on Cigarette Smoking

Study Overview
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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.

Official Title
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Effects of Intranasal Oxytocin on Cigarette Smoking

Conditions
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Nicotine Dependence, Tobacco Smoking

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo then Intranasal Oxytocin (40 IU)<br>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<br> <br> * Other names: Pitocin;Drug: Placebo<br> <br> * Other names: Ocean Spray saline spray;|
| Experimental: Intranasal Oxytocin (40 IU) then Placebo<br>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<br> <br> * Other names: Pitocin;Drug: Placebo<br> <br> * Other names: Ocean Spray saline spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |