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Study on the Effects of Escitalopram, Naltrexone, and Their Combination on Reducing Symptoms of Compulsive Sexual Behavior Disorder in Affected Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different treatments for Compulsive Sexual Behavior Disorder (CSBD). CSBD is a condition where individuals find it difficult to control intense sexual urges, leading to repetitive sexual behaviors that can interfere with daily life. The study will explore the effectiveness of three different treatments: Escitalopram, Naltrexone, and a combination of both, as well as a placebo. Escitalopram is commonly used to treat depression and anxiety, while Naltrexone is often used to manage addiction by reducing cravings.

The purpose of the study is to compare how these treatments affect the severity of CSBD symptoms. Participants will receive one of the treatments or a placebo and will be monitored over a period of time to observe changes in their symptoms. The study will involve taking medication orally, which means swallowing a pill, and participants will be asked to keep a diary to track their behaviors and feelings.

Throughout the study, participants will be assessed using various scales and questionnaires to measure the frequency and intensity of their compulsive sexual behaviors. The study aims to provide insights into which treatment is most effective in reducing the symptoms of CSBD, potentially offering new options for managing this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, gender, and the presence of compulsive sexual behavior disorder (CSBD) as per the ICD-11 guidelines.

    Participants must have a subjective sense of loss of control over sexual behavior and a score of 50 or higher on the CSBD-19 questionnaire.

  2. Step 2

    Medication administration

    Participants are randomly assigned to one of the treatment groups: escitalopram, naltrexone, combined treatment (escitalopram plus naltrexone), or placebo.

    Escitalopram is administered as a 10 mg film-coated tablet taken orally.

    Naltrexone is administered as a 50 mg film-coated tablet taken orally.

    The duration and frequency of medication administration are determined by the study protocol.

  3. Step 3

    Monitoring and evaluation

    Participants are monitored regularly to evaluate the effects of the treatment on the severity of CSBD symptoms.

    Primary outcomes include scores on the CSBD-19 scale, BPS scale, and frequency of compulsive sexual behavior as recorded in a patient diary.

    Secondary outcomes include scores on various scales such as CSBD-DI, HADS, DERS-SF, IIEF-15, and BIS, as well as responsiveness to erotic stimuli.

  4. Step 4

    Completion and follow-up

    Upon completion of the treatment phase, participants undergo a final assessment to measure changes in symptoms and behavior.

    Participants are required to adhere to contraception guidelines for a specified period after the end of the treatment to ensure safety.

Who can join the trial?

14 criteria

  • Must be a male aged between 18-60 years.
  • Must sign an informed consent form, agreeing to participate in the study and allowing the use of personal data.
  • Must express a willingness to participate in all procedures outlined in the study plan.
  • Must feel a loss of control over sexual behavior, such as excessive viewing of pornography, masturbation, or using paid sexual services.
  • Must be seeking specialized help or therapy, including medication, for symptoms or consequences of these behaviors.
  • Must meet the criteria for Compulsive Sexual Behaviour Disorder (CSBD) as defined by the ICD-11 guidelines. This includes:
    • A persistent inability to control intense, repetitive sexual urges or behaviors.
    • These behaviors become the main focus of life, neglecting health, personal needs, or responsibilities.
    • Repeated unsuccessful attempts to control or reduce these behaviors.
    • Continuing these behaviors despite negative consequences or little satisfaction.
    • The pattern lasts for at least 6 months.
    • The behavior is not due to another mental disorder, medical condition, or substance use.
    • The behavior causes significant distress or problems in personal, family, social, educational, or work life.
    • Must score 50 points or higher on the CSBD-19 questionnaire.
    • Must agree to follow rules about contraception and avoid exposing a partner who could become pregnant to the study drug. This includes using a male condom and another effective method of contraception during the study and for 100 days after, if the partner could become pregnant, and for 7 days if the partner is already pregnant.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Compulsive Sexual Behaviour Disorder cannot participate. This is a condition where a person has difficulty controlling their sexual thoughts, urges, or behaviors.
  • Females are not eligible to participate in this study.
  • Individuals under the age of 18 or over the age of 65 are not eligible to participate.
  • Individuals who are part of a vulnerable population, such as those who cannot give informed consent, are not eligible to participate.
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Investigated drugs

  • Escitalopram

    is a medication commonly used to treat depression and anxiety. In this trial, it is being tested to see if it can help reduce the symptoms of compulsive sexual behavior disorder (CSBD).

  • Naltrexone

    is a medication that is often used to help people with alcohol or opioid dependence. It works by blocking the effects of these substances. In this study, it is being evaluated to determine if it can also help reduce the symptoms of CSBD.

  • Escitalopram plus Naltrexone

    is a combination treatment using both escitalopram and naltrexone. This trial is testing whether using these two medications together is more effective in reducing the symptoms of CSBD than using either medication alone.

What is already known about the treatment

  • Escitalopram

    This medication is typically administered orally in tablet form. It is currently well-established in medical literature as a treatment for depression and anxiety disorders. In this clinical trial, it is being investigated for its potential to reduce symptoms of Compulsive Sexual Behaviour Disorder (CSBD). Escitalopram works by increasing the levels of serotonin, a neurotransmitter, in the brain, which helps improve mood and reduce anxiety. It is classified as a selective serotonin reuptake inhibitor (SSRI).

  • Naltrexone

    This medication is usually taken orally in tablet form. It is widely recognized in medical literature for its use in treating alcohol and opioid dependence. In the context of this clinical trial, naltrexone is being studied for its effectiveness in alleviating symptoms of Compulsive Sexual Behaviour Disorder (CSBD). Naltrexone functions by blocking opioid receptors in the brain, which can help reduce cravings and addictive behaviors. It is classified as an opioid antagonist.

Investigated diseases

Compulsive Sexual Behavior Disorder – This condition is characterized by an overwhelming urge to engage in sexual activities, often leading to distress or impairment in daily life. Individuals may find it difficult to control these impulses, resulting in repetitive sexual behaviors. The disorder can cause significant emotional and psychological distress, affecting personal relationships and responsibilities. People with this disorder often experience intense preoccupations with sexual thoughts, fantasies, or urges. The behavior is typically persistent and recurrent, despite negative consequences. Over time, the compulsive nature of the disorder can lead to increased frequency and intensity of sexual activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514490-22-01Protocol codeCSBD-TREstimated enrolment410 patientsSponsorCentrum Medycznego Ksztalcenia Podyplomowego

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