| CTRI Number |
CTRI/2023/05/052725 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Baclofen in alcohol dependence; open label, Randomised, study |
|
Scientific Title of Study
|
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
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BROTOTI MANDAL |
| Designation |
Junior resident, Centre for Addiction Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi Jharkhand 834006.
Ranchi
JHARKHAND
834006
India |
| Phone |
7003866752 |
| Fax |
|
| Email |
brototimandal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sourav Khanra |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Patratoli, Kanke, Jharkhand 834006, Ranchi, JHARKHAND 834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
7903302259 |
| Fax |
|
| Email |
souravpsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sourav Khanra |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Patratoli, Kanke, Jharkhand 834006, Ranchi, JHARKHAND 834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
7903302259 |
| Fax |
|
| Email |
souravpsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand-834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand 834006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Brototi Mandal |
Central Institute of Psychiatry |
Cetre of Addiction Psychiatry, Central Institute of Psychiatry, Ranchi, Girindra Shekhar Bose Centre for Neuroimaging and Radiological sciences at Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND |
7003866752
brototimandal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee ,CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H||Substance Abuse Treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No treatment |
No comparator agent will be given in the study. The control arm will receive the treatment as usual including benzodiazepines. The total dosage of benzodiazepines will be recorded. |
| Intervention |
Tablet Baclofen 10 mg |
Tablet Baclofen will be started day 1 as 10 mg BD and will be hiked 20 mg in every three days till it reaches 60 mg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
1.Not willing to give consent.2. 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,6. Patient is receiving any anti craving medication in last 14 days.7. Patients with complicated withdrawal( Delirium Tremens, Seizure) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in craving of alcohol assessed by Alcohol Craving Questionnaire(ACQ-NOW)from baseline to the end of the study.
2.Change in craving of alcohol assessed by Obsessive Compulsive Drinking Scale (OCDS)from baseline to the end of the study.
3. Change in withdrawal assessed by CIWA-Ar from baseline to the end of study. |
Baseline, Day 8, Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
3.Change in Clinical Global Index-Improvement(CGI-I) score from baseline to the end of the study.
4.Total dosage of Benzodiazepines required to reach CIWA-Ar below 10
4.Number of days required to reach CIWA-Ar below 10 |
Baseline, Day 8, Day 21
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
28/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |