(415) A Randomized Controlled Trial Comparing Fluoxetine and Naltrexone for Compulsive Sexual Behavior Disorder: Sociodemographic and Clinical Characteristics and Study Feasibility

Introduction Compulsive Sexual Behavior Disorder (CSBD) is characterized by a persistent inability to control sexual impulses and urges leading to repetitive sexual behaviors. The conditions is linked with significant distress, negative consequences and impairment across various life domains. Although the World Federation of Societies of Biological Psychiatry recommend psychoeducation and psychotherapy as first-line treatments, guidelines also include selective serotonin reuptake inhibitors (SSRIs) or Naltrexone if satisfactory results are not achieved, depending on the severity of CSBD and comorbid mental conditions. However, evidence for the pharmacological treatment of CSBD remains sparse, with only one randomized-controlled trial in the past 20 years. Objective Given the high prevalence of CSBD and its associated adverse consequences, the need for effective treatment is essential. Therefore, the main objective of the study was to evaluate treatment effects. The presentation aims to review the clinical profile of participants enrolled in this drug trial and evaluate their implications for the generalizability of the findings. Additionally, considerations regarding validity and feasibility will be addressed. Methods Individuals who sought treatment for CSBD, who provided consent for on-site assessment as part of a drug trial at a specialized sexual medicine centre, were independently evaluated by both a psychiatrist and a psychologist to confirm the ICD-11 diagnostic criteria and eligibility. Participant characteristics were obtained through self-report questionnaires and structured interviews. Eighty adults with CSBD with or without paraphilic disorders were randomized to receive either naltrexone or the SSRI fluoxetine for eight weeks, followed by a six-week wash-out period. Baseline characteristics were analyzed using descriptive statistics. Results Recruitment lasted 3.5 years, possibly extended by the COVID-19 pandemic. Sociodemographic and clinical data will be presented and contextualized within the framework of CSBD research. Conclusions Considerations related to validity, generalizability, and feasibility will be discussed to enhance clinicians’ understanding of potential treatment outcomes and to support researchers in designing future clinical trials. Disclosure No