Sexual Dysfunctions in Alcohol Use Disorders on Baclofen Versus Non-Baclofen Alcohol Deaddiction Treatment: A Randomized Clinical Trial

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

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**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.

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**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.

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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.

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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

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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.

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Investigations:

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

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**Ethical Clearance:**Approved by the Institutional Ethics Committee of BLDE (DU), Vijayapura.