A Comparison Study of Gabapentin versus Baclofen in Insomnia Associated with Alcohol Use Craving for Alcohol and Alcohol Consumption Parameters
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Assessment of sleep parameters post detoxification in alcohol dependence.
研究概览
简要总结
STUDY PROCEDURE
- INCLUSION AND CONSENT
Any patient determined by the treating psychiatrist for the management of AUD, and satisfying inclusion with exclusion criteria, shall be offered to participate in the study. Written informed consent shall be obtained from the patient and primary caregiver (living with the patient).
2. PROCEDURE ON THE DAY OF ENROLLMENT
The patient shall be started on benzodiazepines for detoxification until the Clinical Institute Withdrawal Assessment of Alcohol Scale, revised (CIWA-Ar) is zero (38) following which the Socio-demographic Proforma, Alcohol Use Parameters Proforma, Severity of Alcohol Dependence Questionnaire (SADQ), and Alcohol use disorder identification test (AUDIT) shall be administered to the patient for basic details. The patient shall be randomly allotted one of the drugs i.e. Gabapentin or Baclofen based on computer generated randomized sequence. The randomization has been done to reduce the effect of bias. The initial starting dose of Baclofen and Gabapentin will be 40 mg per day and 300mg per day respectively. The doses for the drug shall be titrated during follow-ups with the course of study. The Penn Alcohol Craving Scale (PACS) and Pittsburgh Sleep Quality Index Hindi Version (PSQI-H) shall be administered on the patient for baseline values. The patient shall be prescribed tab. Thiamine as usual to all patients with both drugs. The patients will be instructed to take the medication 30-60 minutes before bedtime. The patient can be discharged and followed up in an out-patient setting.
3. PROCEDURE ON FIRST FOLLOW-UP (1 WEEK)
The patient is asked to follow up with his relative 1week post-discharge. The patient shall be enquired about the alcohol parameters and administered the PACS and PSQI-H. The patient upon examination and depending on the scores calculated for craving and sleep scales, dose titration of either of the drugs shall be done. The dose of Baclofen shall be increased by 20 mg whereas that of Gabapentin will be increased by 100mg. The maximum dose of Gabapentin and Baclofen prescribed for the patients will be 600mg per day and 60 mg/day. It has been demonstrated that higher doses of Gabapentin up to 1800 mg per day have a stronger effect on alcohol use disorder abstinence maintenance (39). Dose monitoring will be done by baseline creatinine levels before and during the treatment. The maximum dose of baclofen that has been used is up to 270 mg per day (40).
4. PROCEDURE ON SECOND FOLLOW UP (4 WEEKS)
Similarly, as in first follow up, the patient shall be enquired about the alcohol parameters and administered the PACS and PSQI-H. The dose titration may be done as per need for the patients.
5. PROCEDURE ON THIRD FOLLOW UP (8 WEEKS)
Similarly, the patient shall be enquired about the alcohol parameters and administered the PACS and PSQI-H. With the final assessment, the participation of the patient in the study will cease. The treatment shall be continued as usual for all the patients.
6.DROPOUT
Any patient during the course of the study, who consumes alcohol or did not follow up within 4-8 weeks shall be considered as a dropout from the study. The patient shall continue to seek treatment as usual from the institution. Also if clinical need arises for any need of addition of an extra medication either for his co-morbid psychiatric or medical illness, medication will be added as per need and subsequently be considered as a drop out from study.
STATISTICAL ANALYSIS
Descriptive and inferential statistics will be computed using statistical software. Data will be reported as mean ± standard deviation unless otherwise indicated, with a significance level set at 0.05. Both the treatment groups will be compared on baseline demographic, sleep, drinking, independent variables with sleep and craving dependent variables and any significant differences were used as covariates in the primary analyses. Intention to treat analysis will also be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Aged between 18-45 years
- •Is fulfilling the criteria of DSM-5 of Alcohol Use Disorder
- •Detoxified at the in-patient or out-patient Psychiatry department of BMHRC
- •Is assessed to be suffering from IAAC at the time of completion of detoxification
- •Can read Hindi or English
- •Is willing to give informed consent.
排除标准
- •EXCLUSION CRITERIA
- •Any other co-morbid substance use disorder other than Nicotine Use Disorder.
- •Any co-morbid psychiatric Disorder like Major Depression, Bipolar Mood Disorder, Schizophrenia etc.
- •that can affect sleep.
- •Presence of any co-morbid medical conditions that contradicts the use of Gabapentin or Baclofen (Gabapentin and Baclofen primarily eliminated via kidneys).
- •On any Medication that is known to affect sleep e.g. sedating antidepressants, anticonvulsants, antipsychotic agents, centrally acting antihistamines or antihypertensives, oral corticosteroids, sedative-hypnotics, psychomotor stimulants, or theophylline as part of a General Medical Condition.
- •Known case of co-morbid Neurological condition, Obstructive Sleep Breathing Disorder or any sleep disorder.
- •Most Common adverse effects associated with Baclofen – oversedation, confusion, muscle weakness, vertigo, and nausea and with Gabapentin – dizziness, fatigue, ataxia, somnolence, nausea, etc.
- •History of hypersensitivity to Gabapentin or Baclofen.
结局指标
主要结局
Assessment of sleep parameters post detoxification in alcohol dependence.
时间窗: 0 week( Baseline) , 1 week, 4 week, and 8 week.
次要结局
- Assessment of craving post detoxification in alcohol dependence.(0 week( Baseline) , 1 week, 4 week, and 8 week.)
研究者
Tanveer Kaur
BMHRC