Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Drinks Consumed During an Ad-libitum Drinking Period
研究概览
简要总结
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21 and over
- •Able to read and write in English
- •Heavy drinker
排除标准
- •Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
- •Significant hepatocellular injury
- •Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- •Women who are pregnant or nursing
- •Suicidal, homicidal, or evidence of severe mental illness
- •Prescription of any psychotropic drug in the 30 days prior to study enrollment
- •Blood donation within the past 8 weeks
- •Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months
- •Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis
- •Specific exclusions for administration of nicotine patch not specified above including history of dermatoses
- •Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray
- •Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
研究组 & 干预措施
patch+spray
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
干预措施: 21mg transdermal nicotine patch (Nicoderm CQ) (Drug)
patch+spray
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
干预措施: 1mg nicotine nasal spray (Drug)
patch+placebo spray
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
干预措施: 21mg transdermal nicotine patch (Nicoderm CQ) (Drug)
patch+placebo spray
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
干预措施: placebo nasal spray (Drug)
结局指标
主要结局
Number of Drinks Consumed During an Ad-libitum Drinking Period
时间窗: Two hour ad-libitum drinking period during laboratory session
Participants are presented with alcohol beverages and allowed to drink at their leisure.
次要结局
- Craving for Alcohol(first measurement during laboratory session (+60 minutes after beginning of laboratory session))
研究者
Sherry McKee
Associate Professor of Psychiatry
Yale University