The Neural Mechanisms Associated With Alcohol and Cigarette Craving in Alcohol Use Disorder Smokers During Oxytocin Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Alcohol craving
研究概览
简要总结
This proposed research seeks to examine the behavioral and neural substrates of intranasal oxytocin compared to placebo on alcohol cue-induced alcohol and cigarette craving smokers with an alcohol use disorder (AUD). Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures (heart rate and blood pressure) and mood measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •18 to 55 years of age
- •meet criteria for Alcohol Use Disorder DSM-5 diagnosis
- •meet the National Institute on Alcohol Abuse and Alcoholism criteria for heavy-drinking
- •smoke at least ≥5 cigarettes/day for at least a year, verified with breath carbon monoxide level > 5 ppm
- •in good health as confirmed by medical history, physical examination and lab tests
- •willing to take the medication and adhere to the study procedures
- •breath alcohol concentration (BrAC) = 0.00 at each visit
- •understand informed consent and questionnaires written in English at an 8th grade level
- •right-handedness
- •normal to normal-corrected vision
排除标准
- •positive urine test for pregnancy
- •women who are breast-feeding
- •body mass index > 40
- •current or prior history of any clinically significant disease, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, positive hepatitis or HIV test that could affect study participation, as determined by the study physician
- •history of suicide attempts
- •current diagnosis of substance dependence other than alcohol, nicotine or cannabis as assessed by self-report and urine toxicology screen at baseline
- •current use of psychoactive medications or any medication that may interact with oxytocin
- •history of hypersensitivity to oxytocin
- •chronic rhinitis or sinusitis
- •clinically significant electrolyte abnormalities
- •vasoconstricting medications or prostaglandins
- •clinically significant medical abnormalities: unstable hypertension, bilirubin >150% of the upper normal limit (UNL), ALT/AST >500% the UNL, creatinine clearance ≤60 dl/min)
- •significant alcohol withdrawal symptoms, defined as a CIWA-Ar > 8
- •positive urine drug screen at baseline for any excluded substances
- •individuals seeking treatment
- •meets DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
- •claustrophobia
- •any contraindications with the MRI machine
研究组 & 干预措施
Oxytocin nasal spray
干预措施: Oxytocin nasal spray (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Alcohol craving
时间窗: 1 day
average alcohol craving during the cue-reactivity task
Cigarette craving
时间窗: 1 day
average cigarette craving during the cue-reactivity task
Brain activity
时间窗: 1 day
BOLD response when comparing alcohol to neutral cues during fMRI
次要结局
- Alcohol and cigarette consumption(5-7 days)
研究者
Kimberly Goodyear
Assistant Professor
Brown University