NCT02649231已完成2 期
A Phase II, Randomised, Double-blind, Placebo- Controlled, Multi-site, Parallel Group Clinical Trial to Examine Ketamine as a Pharmacological Treatment for Alcohol Dependence in an Alcohol Dependent Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Percentage Days Abstinent
研究概览
简要总结
96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. Primary endpoints will be % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet either a) DSM-5 criteria for severe alcohol use disorder and b) DSM-IV criteria for alcohol dependence within the last 12 months;
- •Currently abstinent from alcohol (breathalyser BAC level 0.00) and negative urine drug screening (participants testing positive for THC who do not have a history or current cannabis dependency may be included);
- •Minimum of mild depression(>14 on Beck Depression Inventory-II);
- •Capacity to give informed consent as defined by GCP guidelines;
- •Willing and able to wear SCRAM-X bracelet for 6 months;
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; True abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs. For the purpose of clarity, True abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception;
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment and on day of first treatment.
排除标准
- •Currently taking any other relapse prevention medication or anti-depressants;
- •Uncontrolled hypertension, systolic 140mm Hg or greater and diastolic 90mm Hg or greater;
- •<16 or > 35 BMI
- •History of psychosis, or in a first-degree relative as identified by DSM-5 or DSM-IV SCID; co-morbid current psychiatric diagnosis excluding depression, identified via self-reported or identified by a medical professional;
- •Previous or current diagnosis of substance dependence / severe substance misuse disorder;
- •History of neuropsychological difficulties
- •One or more previous confirmed seizures;
- •Currently taking daily prescribed medication contraindicated in the SPC with ketamine:
- •Barbiturates and/or narcotics
- •Atracurium and tubocurarine
- •Central nervous system (CNS) depressants (e.g. phenothiazines, sedating H1 - blockers or skeletal muscle relaxants)
- •Anxiolytics, sedatives and hypnotics
- •Thiopental, thyroid hormones
- •Antihypertensive agents
- •Theophylline and methylxanthines.
- •Halogenated anaesthetics
- •OR psychotropic drug use at screening assessments or during treatment weeks
- •Liver function tests > 3 times normal levels
- •Where there are "special warnings or precautions for use" according to the SPC and where risk vs benefit ratio is not in favour of giving ketamine, with assessment made by physical examination by medically qualified trial personnel, self-report or inspection of the medical notes:
- •Acute intermittent porphyria
- •Dehydration or hypovolemia
- •Hyperthyroidism, or patients receiving thyroid replacement
- •Pulmonary or upper respiratory tract infection
- •Severe Coronary artery disease, Cerebrovascular accident or cerebral trauma
- •Known glaucoma or globe injuries
- •Neurological condition/brain damage
- •Intracranial mass lesions, presence of head injury or hydrocephalus
- •Suicidal ideation.
- •Not willing to use effective contraception or (females) take pregnancy test;
- •Allergic reaction to ketamine;
- •>10 previous detoxifications from alcohol;
- •Pregnant or breastfeeding;
- •Allergies to excipients of IMP or placebo;
- •Use of another experimental investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment.
研究组 & 干预措施
Ketamine+Psychological Therapy
Experimental
Ketamine with psychological therapy
干预措施: Psychological Therapy (Behavioral)
Ketamine+Psychological Therapy
Experimental
Ketamine with psychological therapy
干预措施: Ketamine (Drug)
Ketamine+Education
Active Comparator
ketamine with alcohol education
干预措施: Ketamine (Drug)
Ketamine+Education
Active Comparator
ketamine with alcohol education
干预措施: Alcohol Education (Behavioral)
Placebo+Psychological Therapy
Active Comparator
placebo with psychological therapy
干预措施: Placebo (Drug)
Placebo+Psychological Therapy
Active Comparator
placebo with psychological therapy
干预措施: Psychological Therapy (Behavioral)
Placebo+Education
Placebo Comparator
placebo with simple alcohol education
干预措施: Placebo (Drug)
Placebo+Education
Placebo Comparator
placebo with simple alcohol education
干预措施: Alcohol Education (Behavioral)
结局指标
主要结局
Percentage Days Abstinent
时间窗: 6 months
Time line follow back
Relapse Rates
时间窗: 6 months
Time line follow back
次要结局
未报告次要终点
研究者
研究点 (2)
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