Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Weekly Percentage of Heavy Drinking Days
研究概览
简要总结
Primary: The primary objective of the study is to compare the efficacy of intranasal oxytocin in reducing the weekly percentage of heavy drinking days over the 10 weeks of maintenance treatment among subjects with moderate to severe Alcohol Use Disorder (AUD). A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Secondary: Secondary objectives include assessment of other measures of the effects of oxytocin compared with placebo on reduction of alcohol use as well as effects on psychological assessments, alcohol craving, alcohol-related consequences, cigarette smoking and other nicotine use, retention in the study, safety, and application site (nares) tolerability throughout the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 21 years of age.
- •Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated).
- •Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
- •Be seeking treatment for problems with alcohol reduction in drinking.
- •Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- •Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
- •oral contraceptives,
- •contraceptive sponge,
- •double barrier (diaphragm/spermicidal or condom/spermicidal),
- •intrauterine contraceptive system,
- •etonogestrel implant,
- •medroxyprogesterone acetate contraceptive injection,
- •complete abstinence from sexual intercourse, and/or
- •hormonal vaginal contraceptive ring.
- •Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen.
- •Complete all assessments required at screening and baseline.
- •Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week
- •Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week
- •Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical.
- •Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- •Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
- •Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- •Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
- •If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:
- •Dual uptake inhibitors
- •Tricyclic antidepressants
- •Bupropion
- •Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.
排除标准
- •Contact study site for exclusion criteria.
研究组 & 干预措施
Intranasal Oxytocin
Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL.
干预措施: Instranasal Oxytocin (Drug)
Instrasal Placebo
Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL.
干预措施: Instranasal Oxytocin (Drug)
结局指标
主要结局
Weekly Percentage of Heavy Drinking Days
时间窗: Weeks 3-12
The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method.
次要结局
- Percentage of Subjects With no Heavy Drinking Days(weeks 3-12)
- Percentage of Subjects Abstinent From Alcohol(Weeks 3-12)
- Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease(weeks 3-12)
- Percentage of Days Abstinent Per Week(weeks 3-12)
- Weekly Mean Number of Drinks Per Week(weeks 3-12)
- PROMIS Pain Interference Score(weeks 3-12)
- Profile of Moods States (POMS) - Total Mood Disturbance(weeks 3-12)
- Urge to Drink Alcohol Craving Score(weeks 3-12)
- Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease(weeks 3-12)
- Number of Alcohol Use Disorder Symptoms (MINI)(week 13)
- Cigarettes Smoked Per Week Among Smokers(weeks 3-12)
- Abstinence From Cigarette Smoking Among Smokers(weeks 3-12)
- Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users(weeks 3-12)
- Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)(weeks 3-12)
- PROMIS Sleep Disturbances Score(weeks 3-12)
- PROMIS Alcohol-related Negative Consequences Score(weeks 3-12)
- Weekly Mean Drinks Per Drinking Day(weeks 3-12)