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CTRI Number  CTRI/2025/03/083639 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of Baclofen on Sexual Health in Alcohol Recovery: A Clinical Study 
Scientific Title of Study   Sexual Dysfunctions in Alcohol Use Disorders on Baclofen Versus Non-Baclofen Alcohol Deaddiction Treatment: A Randomized Clinical Trial 
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 ADITYA AITHAL 
Designation  POST GRADUATE STUDENT 
Affiliation  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura 
Address  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura.
Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura
Bijapur
KARNATAKA
586103
India 
Phone  9449147895  
Fax    
Email  aditya.aithal18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Ramdurg 
Designation  HOD & Professor, Department of Psychiatry 
Affiliation  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura 
Address  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura.
Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura.
Bijapur
KARNATAKA
586103
India 
Phone  9611281386  
Fax    
Email  santoshramdurg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ADITYA AITHAL 
Designation  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura 
Affiliation  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura 
Address  Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura
Shri B.M Patil medical college hospital and research centre, BLDE university, Vijayapura
Bijapur
KARNATAKA
586103
India 
Phone  9449147895  
Fax    
Email  aditya.aithal18@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychiatry, Shri B.M. Patil Medical College Hospital and Research Centre, Shri Bangaramma Sajjan Campus, Vijayapura 586103  
 
Primary Sponsor  
Name  DR ADITYA AITHAL 
Address  Department of Psychiatry, Shri B.M. Patil Medical College Hospital and Research Centre, Shri Bangaramma Sajjan Campus, Vijayapura 586103  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ADITYA AITHAL  SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  OPD NO 19, DEPARTMENT OF PSYCHIATRY, SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA SAJJAN CAMPUS VIJAYAPURA 586103 Bijapur KARNATAKA
Bijapur
KARNATAKA 		 9449147895

aditya.aithal18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC SBMPMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F10||Alcohol related disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  baclofen  one group will receive baclofen  
Comparator Agent  normal deaddiction treatment without Anti craving medication  normal deaddiction treatment without Anti craving medication 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Men with alcohol use aged 18-45 years
A written informed consent.
Currently having an active sexual life. 
 
ExclusionCriteria 
Details  Significant psychiatric or sexual dysfunction before alcohol use.
Refusal to give informed consent.
Patients who suffer from organic brain syndrome, comorbid opioid usage and dependence, and long-term comorbid disorders that may lead to sexual dysfunction.
Furthermore, patients on any other concurrent medications that may worsen sexual dysfunction—such as beta-blockers, ACE inhibitors, ARB diuretics, PDE-5 inhibitors, or hormonal preparations that may boost libido or enhance sexual functioning—would not be accepted. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assess the Sexual Dysfunction in men with alcohol dependence, currently abstaining and receiving baclofen vs patients receiving regular treatment for alcohol deaddiction.  To assess the sexual functioning of patients with alcohol dependence at the time of admission before starting the treatment.
To assess the sexual functioning of the patient after 1 month of abstinence from alcohol and 1 month of starting baclofen vs regular treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the sexual functioning of patients with alcohol dependence at the time of admission before starting the treatment.
To assess the severity of Alcohol dependence at the time of admission.
To assess the sexual functioning of the patient after 1 month of abstinence from alcohol & 1 month of starting baclofen vs regular treatment. 		 To assess the sexual functioning of patients with alcohol dependence at the time of admission before starting the treatment.
To assess the sexual functioning of the patient after 1 month of abstinence from alcohol & 1 month of starting baclofen vs regular treatment 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2025 
Date of Study Completion (India) 09/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 09/11/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Summary of the Dissertation

Title:
Sexual Dysfunctions in Alcohol Use Disorders on Baclofen vs. Non-Baclofen Alcohol Deaddiction Treatment – A Randomized Clinical Trial

Researcher: Dr. Aditya Aithal (P.G. in Psychiatry)
Guide: Dr. Santosh Ramdurg (Professor & HOD, Department of Psychiatry)
Institution: BLDE (DU) Shri B.M. Patil Medical College Hospital & Research Centre, Vijayapura, Karnataka

Introduction & Need for Study:

Alcohol dependence is a chronic condition characterized by an inability to control alcohol consumption despite harmful consequences. Alcohol affects neurotransmitters like GABA, leading to sedation and contributing to sexual dysfunction. Baclofen, a GABA-B receptor agonist, is used to treat alcohol dependence but may also influence sexual functioning.

The study aims to address the gap in research regarding sexual dysfunction caused by Baclofen compared to other alcohol deaddiction treatments. Understanding these effects is essential as sexual dysfunction may lead to relapse in patients undergoing treatment.

Aim:

To assess sexual dysfunction in men with alcohol dependence who are abstaining from alcohol and receiving Baclofen compared to those receiving standard non-Baclofen treatments.

Objectives:

  1. Evaluate sexual functioning in alcohol-dependent patients at admission (before starting treatment).
  2. Assess the severity of alcohol dependence at admission.
  3. Compare sexual functioning after one month of treatment between Baclofen and non-Baclofen groups.

Methodology:

  • Study Design: Randomized Clinical Trial (18-month duration: January 2024 – June 2025)

  • Sample Size: 110 participants (55 in each group)

  • Inclusion Criteria:

    • Male patients aged 18-45 with alcohol dependence
    • Active sexual life
    • Written informed consent

  • Exclusion Criteria:

    • Pre-existing psychiatric or sexual dysfunction
    • Use of medications affecting sexual function
    • Organic brain syndromes and comorbid opioid use

  • Data Collection:

    • Severity of Alcohol Dependence Questionnaire (SADQ)
    • Change in Sexual Functioning Questionnaire (CSFQ)
    • International Index of Erectile Function (IIEF)

  • Procedure:

    • Patients meeting ICD-10/11 alcohol dependence criteria will be randomized into two groups: Baclofen and non-Baclofen treatment.
    • Sexual function will be assessed at admission and one month after treatment initiation.

  • Statistical Analysis:

    • Data analyzed using SPSS (Version 26)
    • Independent t-test for continuous variables, Chi-square for categorical variables
    • p < 0.05 considered statistically significant

Key Findings from Literature Review:

  • Alcohol dependence is significantly linked to sexual dysfunction.
  • Baclofen may exacerbate sexual dysfunction compared to other treatments.
  • Previous studies indicate increased sexual dysfunction with Baclofen compared to Disulfiram.
  • Long-term alcohol use correlates with a higher prevalence of sexual dysfunction.

Investigations:

  • Complete Blood Count (CBC)
  • Liver and Renal Function Tests
  • Random Blood Sugar

Ethical Clearance:

Approved by the Institutional Ethics Committee of BLDE (DU), Vijayapura.

 
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