1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sanjuktaghosh18@gmail.com].
   


6. For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - None

STUDY PROCEDURE

1. 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.