| CTRI Number |
CTRI/2024/11/077246 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Anticraving drug utilization in alcohol use disorder |
|
Scientific Title of Study
|
Anticraving drug utilization and risk of relapse in patients with Alcohol Use Disorder |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diya Kiran |
| Designation |
Pharm D Student |
| Affiliation |
Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of
Pharmaceutical Sciences,(Nitte Deemed to be University),
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7899192836 |
| Fax |
|
| Email |
diyakiran2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate Professor and HOD |
| Affiliation |
Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of
Pharmaceutical Sciences,(Nitte Deemed to be University),
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shishir Kumar |
| Designation |
Associate Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Psychiatry, Justice K.S Hegde Charitable Hospital, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
994552098 |
| Fax |
|
| Email |
shishirkumar@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka-575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Others(NIL)] |
|
|
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 |
| Dr Juno J Joel |
Justice KS Hegde Charitable Hospital |
Department of Psychiatry, Justice KS Hedge Charitable Hospital, Deralakatte, Mangaluru, Dakshina Kannada, 575018
Dakshina Kannada
KARNATAKA |
9480470727
junojoel@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F109||Alcohol use, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants of either gender, aged above 18 years.
Participants diagnosed with AUD presented with or without comorbidities taking anti-craving medications for a minimum duration of 1 month after admission
|
|
| ExclusionCriteria |
| Details |
Participants or caretakers of patients with AUD who are unwilling to participate in the study.
Participants/ caretakers who are not responding well to the queries
Participants who quit treatment against medical advice
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The pattern of drinking, extent of anti-craving drug utilisation and craving dynamicity will be studied.
|
0, 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The risk of relapse in patients taking anti-craving drugs will be studied. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Alcohol use disorder
(AUD) causes significant global mortality and frequent relapses due to intense
cravings triggered by internal and external cues. Effective treatment options
include FDA-approved medications like disulfiram, naltrexone, and acamprosate,
along with some off-label drugs. High relapse rates, influenced by factors like
age and social support, highlight the need for effective craving management.
This study focuses on evaluating craving intensity, treatment efficacy, and
relapse likelihood. |