Effect of adjunctive Baclofen on craving, withdrawal, resting and Cue related functional brain connectivity, among patients with alcohol dependence: an Open label, randomized Pharmaco-fMRI study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 3. Change in withdrawal assessed by CIWA-Ar from baseline to the end of study.
研究概览
简要总结
Alcohol use disorder is a major public health burden, and is associated with substantial mortality and morbidity. Alcohol use disorder is a major public health burden, and is associated with substantial mortality and morbidity. Recent literatures have put forth several intrinsically defined functional networks, such as the executive control network (ECN) etc. and the role they play in the pathophysiology of addiction. For exploring alcohol craving response of these brain areas, a the common method is cue exposure paradigm, which involves photographic alcohol related stimuli in non-realistic experimental or clinical settings. Pharmacotherapy is limited only few substances approved by the Federal Drug Administration or the European Medicines Agency for controlling symptoms of withdrawal and craving. But only some of them have shown clear but modest efficacy in meta-analysis of randomised control trial .A promising candidate to control craving can be the muscle relaxant and specific agonist for GABA-B receptor baclofen. More so we can try to use baclofen in withdrawal phase unlike any other anticraving drugs along with conventional way of detoxification. Till date we classically detoxify a patient with symptoms of alcohol withdrawal by benzodiazepines and the dose of benzodiazepines is titrated according to the alcohol intake of the patient. so sometimes we need higher dose also. Benzodiazepines has lots of side effects like cognitive side effects and physical side effects even high dose of benzodiazepines can have risk of respiratory depression. To the best of our knowledge, very few studies have been done about the effect of baclofen in acute withdrawal phase of alcohol along with benzodiazepines, decreasing in the need for high dose of benzodiazepines, also analysing reduction of craving. The results of these studies are also very inconclusive.Also, none of the study has tried to show any biological correlates with the use of Baclofen in withdrawal phase. Hence this study is proposed with following aim and objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients diagnosed with mental and behavioural disorder due to use of alcohol dependence syndrome, currently using the substance(F10.24) as per International classification of disease 10th (ICD 10) clinical description and diagnostic guidelines( WHO, 1993) who are ready to give consent and severity of alcohol dependence Questionnaire (SADQ) score > 20 that is moderate to severe alcohol dependence.
排除标准
- •1.Not willing to give consent.
- •Age <18 years,>50 years.3.Any other comorbid substance use except nicotine and caffeine.4.Participants having any comorbid psychiatric disorders .Participants having any contraindication for fMRI,
- •Patient is receiving any anti craving medication in last 14 days.
- •Patients with complicated withdrawal( Delirium Tremens, Seizure).
结局指标
主要结局
3. Change in withdrawal assessed by CIWA-Ar from baseline to the end of study.
时间窗: Baseline, Day 8, Day 21
1.Change in craving of alcohol assessed by Alcohol Craving Questionnaire(ACQ-NOW)from baseline to the end of the study.
时间窗: Baseline, Day 8, Day 21
2.Change in craving of alcohol assessed by Obsessive Compulsive Drinking Scale (OCDS)from baseline to the end of the study.
时间窗: Baseline, Day 8, Day 21
次要结局
- 1.Change in resting state brain connectivity of Executive Control Network among patients with alcohol dependence from baseline to the end of the study.(2.Change in cue related functional brain connectivity of Executive Control Network among patients with alcohol dependence from baseline to the end of the study.)