Randomised Control Trial of fluoxetine for the treatment of problematic sexual arousal in adult males serving a custodial sentence for a sexual offence.

Primary research question: In men incarcerated for sexual offences who are referred for MMSA, fluoxetine prescribed over 6 months will be more effective in reducing problematic sexual arousal compared to placebo, as measured by the sexual compulsivity scale. Background: Sexual offending incurs tangible costs to society. Between 45-75% of men with a sexual conviction experience/are motivated by problematic sexual arousal. At present, the primary treatment approach for people is psychological. Yet none of the psychological interventions address problematic sexual arousal, despite this being a key criminogenic factor for sexual reoffending and a barrier to engagement in psychological interventions which address other criminogenic factors. To date, there has been one randomised control trial on Selective Serotonin Reuptake Inhibitors and sexual compulsivity with a 12-week double-blind study with a non-forensic sample of homosexual and bisexual patients diagnosed with sexual addiction; this study demonstrated significant treatment effects. No randomised control trials have been conducted on Selective Serotonin Reuptake Inhibitors with individuals convicted of a sexual offence(s). Aims and objectives: Does fluoxetine reduce problematic sexual arousal and increase the wellbeing of men with a sexual conviction compared to a placebo using a double blind, parallel, RCT design. We will conduct an economic analysis of the effectiveness of fluoxetine in improving quality of life for patients. The research includes a qualitative study that will examine the barriers and catalysts for prison staff referring men to healthcare for medication to manage problematic sexual arousal. Methods: Within eight prison treatment sites across the UK, a total of 196 patients referred for treatment, and who are confirmed by psychiatrists as having problematic sexual arousal, will be allocated randomly to receive either fluoxetine or placebo (over encapsulated to look identical). Patients will be assessed for problematic sexual arousal, wellbeing, quality of life, paedophilia, before treatment (baseline) and at 3 and 6 month follow-ups. The primary outcome is a measure of sexual compulsivity at the 6-month follow-up. Health economic data will be collected pre-treatment and at 6-month follow-up. A process evaluation will include, inter alia, assessment of fidelity of treatment delivery. Qualitative interviews with samples prison staff will be analysed to understand the barriers and catalysts for prison staff in referring men for medication to manage problematic sexual arousal. Timelines for delivery: 60 months overall duration, including an internal pilot (to m.18) and one qualitative study (m. 3-15). Anticipated impact and dissemination: We will publish the findings, present them at scientific and public meetings, and disseminate them widely to professional and lay audiences. If the intervention is supported, we would expect the medication treatment pathway to be expanded within the criminal justice system. The findings may also impact positively on primary care prescribing for those seeking early intervention within the community.