Double-blind, placebo-controlled randomised clinical trial on flexible doses of escitalopram and naltrexone in the treatment of men with compulsive sexual behaviour disorder: study protocol presentation
- 1Department of Psychiatry, Centre of Postgraduate Medical Education, Warsaw, Poland
- 2Institute of Psychology, Polish Academy of Sciences, Warsaw, Poland
- 3Institute for Neural Computations, University of California San Diego, La Jolla, California, USA
Abstract
Background Recent research has led to a better understanding of biological and psychosocial correlates of compulsive sexual behaviour disorder (CSBD). Psychotherapy is considered a first-line treatment strategy, while evidence on the use of pharmacotherapy is still scarce. This study aimed to provide new data on the efficacy of a selective serotonin reuptake inhibitor and an opioid receptor antagonist used as monotherapy or in combination in CSBD.Methods and analysis 410 adult men seeking treatment due to perceived loss of control over sexual behaviour and its negative consequences, meeting the ICD-11 diagnostic guideline of CSBD and scoring ≥50 on the Compulsive Sexual Behavior Disorder Scale, used for assessment of CSBD according to ICD-11 guidelines (CSBD-19) questionnaire, will be randomised to 24-week, double-blind treatment with either escitalopram 10–20 mg, naltrexone 25–50 mg, combined treatment or placebo (fixed- and flexible-dosing for the first and subsequent 12 weeks, respectively) with a 12-month follow-up after completing the medication. Men with relevant psychiatric or neurological comorbidity or cognitive impairment, with current psychoactive substance dependence or compulsive gambling, already using psychotropic medications, with positive drug test or significant blood lab test abnormality, or any medical or concomitant treatment-related contraindications for use of any of the investigated medications will be excluded from participation in this clinical trial. Patients will be assessed using structured clinical interviews, validated questionnaires, ecological momentary assessment and functional electroencephalography. Pharmacovigilance and lab tests will be provided throughout the active treatment phase to monitor its safety and tolerability.Main outcome measure will include changes in the severity of symptoms of compulsive sexual behaviours operationalised using CSBD-19 and Brief Pornography Screen (BPS) questionnaires as well as diary assessments. A mixed multivariate analysis of variance (MANOVA) model will be applied with three measurements (before therapy initiation, after 12—primary endpoint and 23 weeks of treatment—secondary endpoint) in the four treatment arms. Regression models will be used in the search of predictors of clinical outcomes and correlation analyses to measure the relationship between psychometric outcomes, diary variables and neuronal biomarkers.Ethics and dissemination Ethical approval was granted as part of the Clinical Trials Information System (CTIS) Part II assessment in Poland on 17 February 2025. The trial was authorised in Poland on 24 February 2025 (EU CT approval reference: 2024-514490-22-01). The results of the study will be presented during conferences and published in peer-reviewed journals.Trial registration number EUCT: 2024-514490-22-01.
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BibTeX
@article{lewstarowicz2026doubleblind,
title = {{Double-blind, placebo-controlled randomised clinical trial on flexible doses of escitalopram and naltrexone in the treatment of men with compulsive sexual behaviour disorder: study protocol presentation}},
author = {Michał Lew-Starowicz and Małgorzata Draps and Kacper Wilk and Pawel Wisniewski and Mateusz Gola},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-125612},
url = {https://doi.org/10.1136/bmjopen-2026-125612},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Double-blind, placebo-controlled randomised clinical trial on flexible doses of escitalopram and naltrexone in the treatment of men with compulsive sexual behaviour disorder: study protocol presentation
AU - Michał Lew-Starowicz
AU - Małgorzata Draps
AU - Kacper Wilk
AU - Pawel Wisniewski
AU - Mateusz Gola
PY - 2026
DA - 2026/10/23
JO - BMJ Open
DO - 10.1136/bmjopen-2026-125612
UR - https://doi.org/10.1136/bmjopen-2026-125612
AB - Background Recent research has led to a better understanding of biological and psychosocial correlates of compulsive sexual behaviour disorder (CSBD). Psychotherapy is considered a first-line treatment strategy, while evidence on the use of pharmacotherapy is still scarce. This study aimed to provide new data on the efficacy of a selective serotonin reuptake inhibitor and an opioid receptor antagonist used as monotherapy or in combination in CSBD.Methods and analysis 410 adult men seeking treatment due to perceived loss of control over sexual behaviour and its negative consequences, meeting the ICD-11 diagnostic guideline of CSBD and scoring ≥50 on the Compulsive Sexual Behavior Disorder Scale, used for assessment of CSBD according to ICD-11 guidelines (CSBD-19) questionnaire, will be randomised to 24-week, double-blind treatment with either escitalopram 10–20 mg, naltrexone 25–50 mg, combined treatment or placebo (fixed- and flexible-dosing for the first and subsequent 12 weeks, respectively) with a 12-month follow-up after completing the medication. Men with relevant psychiatric or neurological comorbidity or cognitive impairment, with current psychoactive substance dependence or compulsive gambling, already using psychotropic medications, with positive drug test or significant blood lab test abnormality, or any medical or concomitant treatment-related contraindications for use of any of the investigated medications will be excluded from participation in this clinical trial. Patients will be assessed using structured clinical interviews, validated questionnaires, ecological momentary assessment and functional electroencephalography. Pharmacovigilance and lab tests will be provided throughout the active treatment phase to monitor its safety and tolerability.Main outcome measure will include changes in the severity of symptoms of compulsive sexual behaviours operationalised using CSBD-19 and Brief Pornography Screen (BPS) questionnaires as well as diary assessments. A mixed multivariate analysis of variance (MANOVA) model will be applied with three measurements (before therapy initiation, after 12—primary endpoint and 23 weeks of treatment—secondary endpoint) in the four treatment arms. Regression models will be used in the search of predictors of clinical outcomes and correlation analyses to measure the relationship between psychometric outcomes, diary variables and neuronal biomarkers.Ethics and dissemination Ethical approval was granted as part of the Clinical Trials Information System (CTIS) Part II assessment in Poland on 17 February 2025. The trial was authorised in Poland on 24 February 2025 (EU CT approval reference: 2024-514490-22-01). The results of the study will be presented during conferences and published in peer-reviewed journals.Trial registration number EUCT: 2024-514490-22-01.
SN - 2044-6055
ER -