Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial
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
- Proportion of Heavy Drinking Days
研究概览
简要总结
Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming alcohol heavily for long periods and are physically and psychologically dependent on alcohol.
Participants: 50 adults with alcohol dependence
Procedures (methods): Oxytocin or placebo will be administered three times a day for the first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before, during and at the end of the trial, each subject will undergo evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks to evaluate for post-medication safety and efficacy
详细描述
The purpose of this research study is to learn whether oxytocin treatment decreases drinking and alcohol craving in people who have been consuming alcohol heavily for long periods and are unable to stop drinking on their own. Oxytocin is made naturally and is released in parts of the brain where it acts like a chemical signal from one cell to another. Oxytocin is approved by the Food and Drug Administration for stimulating labor in pregnant women but is not approved as a treatment to decrease alcohol drinking.
People who drink large amounts of alcohol every day or many days per week for weeks or months undergo chemical changes in their brains. They continue to drink frequently and heavily because, even though they may know drinking is not good for their health, they experience unpleasant symptoms if they stop or decrease drinking. Those symptoms can include increased anxiety, difficulty sleeping, difficulty tolerating stress, mild to moderate withdrawal symptoms such as tremors, nausea, feeling sweaty and/or headaches, and cravings to drink. Studies found that giving oxytocin to alcohol-addicted animals reduced symptoms when they were put into alcohol withdrawal. A pilot study conducted at UNC found that twice daily intranasal doses of oxytocin decreased withdrawal symptoms in heavy drinkers who were admitted to a hospital for medical detoxification to come off alcohol.
This study will test whether daily intranasal oxytocin treatment for 12 weeks will decrease how much subjects drink as well as craving for alcohol and anxiety.
Prospective subjects must have been drinking large amounts of alcohol for a sustained period to qualify for this study and want help to stop or cut back on their drinking. Subjects will self-administer oxytocin or placebo in this study in an intranasal spray. The placebo spray contains all of the ingredients of the oxytocin spray EXCEPT oxytocin. Subjects' assignment to oxytocin or placebo treatment will be random (like a flip of a coin).
Subjects must sign a consent form to take part in this study. Their participation in the study will last up to 14-15 weeks. Prospective subjects will be recruited from the community through advertisements (radio, social media, mass emails, etc). Those who respond to advertisements will undergo initial screening over the phone. Prospective subjects who appear to meet study criteria based on the phone screen will give informed consent and undergo more detailed evaluation during a screening clinic visit. If they are found to meet study criteria, they will shortly thereafter attend another clinic visit (randomization clinic visit) during which they will be randomized to oxytocin or placebo treatment and take their first test dose under study personnel supervision. They will then take home the bottle contained the intranasal study medication to which they have been randomized and self-administer intranasal test doses at home for the remainder of the 12-week test treatment period. New intranasal spray bottles will be exchanged for old every 2 weeks. Subjects will attend 8 additional clinic visits over a 12 week period after the randomization clinic visit. Each clinic visit will last 1-2 hours.
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
- Double (Participant, Investigator)
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
- •Meeting criteria for DSM-IV-TR alcohol dependence.
- •Consumption of at least 35 standard drinks/week for men or 28 standard drinks/week for women for at least 4 consecutive weeks prior to enrollment into the study.
- •Women who are able to conceive children and who are sexually active must be on an effective form of birth control such as oral contraceptives, IUDs or the use of condoms with spermicide.
- •Competency to give valid informed consent as indicated by a) a Breathalyzer reading at the time the consent form is signed showing an estimated blood alcohol level (BAL) of zero; b) ability to understand the written informed consent form demonstrated by correctly answering questions about the contents of the form after reading the consent form without help (this will also determine whether prospective subjects can read and understand the study questionnaires).
- •Ability to get to appointments either through personal or public transportation.
- •Ages 18-65.
排除标准
- •History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.
- •Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder).
- •History of psychotic disorder or admission for mania, meeting criteria for an eating disorder in the last 2 years, current moderate or severe major depression, current suicidal ideation.
- •Currently meeting DSM-IV TR criteria for dependence on addictive substances other than alcohol except for nicotine or caffeine. Substance abuse disorders are not exclusionary.
- •Consumption during the week prior to enrollment or plans to consume during the 12-week trial of benzodiazepines, barbiturates, anticonvulsants or stimulants.
- •AST or ALT > 5 times ULN, bilirubin > 1.5 X ULN, sodium < 132 or > 150 mMol/L, potassium < 3.2 or > 5.3 mMol/L.
- •Women who are pregnant or breastfeeding.
- •Currently participating in or intent to participate in an additional alcohol treatment program during the study period other than Alcoholics Anonymous.
- •Court-mandated participation in alcohol treatment or pending incarceration.
研究组 & 干预措施
Active
Intranasal oxytocin doses 2-3 times/day for 12 weeks
干预措施: Intranasal Oxytocin (Drug)
Control
Intranasal placebo doses 2-3 times/day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Heavy Drinking Days
时间窗: 12 weeks
Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).
Mean Weekly Drinks Per Drinking Day
时间窗: 12 weeks
The mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.
次要结局
- Alcohol Craving(12 weeks)