Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total oxazepam dosage in milligrams
研究概览
简要总结
This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
- •average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
- •consenting to participate in the study;
- •have residency in Trøndelag County after discharge
排除标准
- •chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
- •dependence on substances other than alcohol, nicotine or caffeine;
- •inadequately treated, unstable and/or compromising medical or psychiatric conditions;
- •low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years;
- •pregnancy; parturition or breast-feeding in the past 6 months;
- •inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;
- •no alcohol in the blood and > 15 h since last intake of alcohol;
- •prior inclusion and participation in the same study.
研究组 & 干预措施
oxytocin
intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel.
Day 3-30: Self-administered intranasal spray as needed, max thrice daily intranasal spray without oxytocin
干预措施: intranasal oxytocin spray (Drug)
Placebo
intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel.
Day 3-30: Self-administered intranasal spray as needed, max thrice daily
干预措施: intranasal spray without oxytocin (Other)
结局指标
主要结局
Total oxazepam dosage in milligrams
时间窗: 3 days
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Alcohol intake
时间窗: 30 days
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
次要结局
- Sleep(30 days)
- motor activity(3 days)
- alcohol craving(day 30)
- Mental distress(day 30)
- patient activity(day 30)
- Socio-emotional recognition(day 30)
- Facial emotional selective attention(day 30)