| CTRI Number |
CTRI/2025/02/081102 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to compare the effectiveness of 100 mg naltrexone and 50 mg naltrexone in participants who have moderate to severe alcohol use problems. The main study aim will be to see how long the participants can stay away from alcohol and the side effects with the 2 doses of nalttrexone |
|
Scientific Title of Study
|
A Double-blind, Cross-over, Randomised Controlled Trial to Compare the Effectiveness of Higher Dose Oral Naltrexone with Standard Dose Oral Naltrexone in Moderate to Severe 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 |
Dr LALCHHANDAMA HAUHNAR |
| Designation |
DM (Superspecialty) Resident / Academic Senior Resident in Addiction Psychiatry |
| Affiliation |
Department of Psychiatry, All India Institute of Medical Sciences, Gorakhpur |
| Address |
Room 232, Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7005405607 |
| Fax |
|
| Email |
damtea.hauhnar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RICHA TRIPATHI |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Room NO.233, Department of Psychiatry, All India Institute of Medical Sciences (AIIMS)
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9999457412 |
| Fax |
|
| Email |
drricha12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr LALCHHANDAMA HAUHNAR |
| Designation |
DM (Superspecialty) Resident / Academic Senior Resident in Addiction Psychiatry, Department of Psychiatry |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Room No. 232, Department of Psychiatry, All India Institute of Medical Sciences
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7005405607 |
| Fax |
|
| Email |
damtea.hauhnar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Kunraghat, Gorakhpur, Uttar Pradesh.
PIN: 273008 |
| Type of Sponsor |
Government medical college |
|
|
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 LALCHHANDAMA HAUHNAR |
All India Institute of Medical Sciences |
Room No. 232, Psychiatry Department
Gorakhpur
UTTAR PRADESH |
07005405607
damtea.hauhnar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Naltrexone |
Tablet Naltrexone 100 mg, once daily, orally, for 3 months followed by Tablet Naltrexone 50 mg, once daily, orally for next 3 months. |
| Comparator Agent |
Tablet Naltrexone 50 mg |
Tablet Naltrexone 50 mg, once daily, orally for 3 months, followed by Tablet Naltrexone 100 mg, once daily, orally for next 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Resident of Gorakhpur and literate enough to understand the questionnaires, fulfilling DSM-5 criteria for alcohol use disorder with severity of alcohol dependence questionnaire (SAD-Q) score of at least 16 (assessed for the preceding 6 months)and Patients willing for inpatient detoxification and abstinence for 1 week. |
|
| ExclusionCriteria |
| Details |
Presence of other moderate to severe substance use disorders except tobacco.
Presence of any major psychiatric condition (except subsyndromal depression or anxiety).
Any acute medical or neurological condition or intellectual disability.
Any chronic medical conditions (malignancy or chronic pain conditions) that may pose a contraindication for opioid antagonist treatment.
History of hypersensitivity to naltrexone in the past.
Active use of any opioids (use of any opioids in the last 7 days).
Evidence of compromised liver function, with liver enzymes raised more than three times the upper normal limit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of participants that become abstinent:
2. If relapse, the number of days of abstinence
3. Number of lapses
4. Number of drinks per day: both for lapse and relapse
5. Severity of craving: The severity of craving will be assessed and quantified using the Penn Alcohol Craving Scale.
6. Treatment completion and dropout in each group.
|
At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Serum aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) levels.
Treatment emergent adverse events
|
6 time points: at the end of 1st, 2nd, 3rd, 4th, 5th and 6th months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
27/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study will be a double-blind crossover randomised controlled trial to compare the effectiveness of 100 mg oral naltrexone with 50 mg naltrexone in moderate to severe alcohol use disorder. It will be a non-funded, hospital-based prospective study for 6 months for each of the 26 patients to be recruited.The primary outcome measures will be the the rate of abstinence, while the secondary outcome measure will be tolerability or adverse events. |