Effects of Intranasal Oxytocin on Cigarette Smoking
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Smoking Lapse Analogue Task (Delay Score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-40
- •Smoke >= 10 cig/day for the past year
- •English fluency
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oxytocin (Drug)
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.
干预措施: Placebo (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.
干预措施: Oxytocin (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.
干预措施: Placebo (Drug)
结局指标
主要结局
Smoking Lapse Analogue Task (Delay Score)
时间窗: 2.5 hours after nasal spray administration
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)
时间窗: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
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)
时间窗: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
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)
时间窗: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
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)
时间窗: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray
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.
次要结局
- Profile of Mood States (Anxious Scale)(30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray)
研究者
Matthew Kirkpatrick
Assistant Professor
University of Southern California