Hormone therapy to treat withdrawal symptoms among men with anabolic androgenic steroid dependence: A pilot study

Use of anabolic-androgenic steroids (AAS) is associated with physical and mental behavioural risks including depression, anxiety, aggression and psychosis. Many users develop AAS-dependence related to endogenous testosterone deficiency (hypogonadism). Hypogonadism is often present for months up to years after AAS-cessation, leading to depression with or without suicidal ideation, fatigue, sleep disorder and sexual dysfunction, and relapse is common. While AAS-users are entitled to psychosocial addiction treatment in Norway, hormone therapy is not an approved treatment of AAS-dependence. Our aim is to examine whether use of endocrine therapy is safe and effective to reduce withdrawal symptoms among AAS-dependent men upon cessation.

In this one-site open off-label longitudinal pilot study at Oslo University Hospital(OUH) 25-30 AAS-dependent men referred to outpatient addiction treatment will be given endocrine therapy consisting of the anti-oestrogen clomiphene citrate for 16 weeks. Participants are recruited through an OUH information service, used by 20-30 AAS-users on average per month. Participants will be compared to AAS-users in another study of men who end AAS-use without similar treatment. Comparison is based on self-reported withdrawal symptoms and other mental health measures including degree of dependence, quality of life, fatigue, depression, suicidal ideation, anxiety, sleep, sexual function, body image perceptions and aggressive behaviour. Health parameters in the intervention group will be monitored using within-subjects repeated measures design before, during intervention, and at follow-up 6 and 12 months after AAS-cessation.

Study inclusion started in December 2021. Preliminary results will be presented and be focused on changes in AAS-dependence symptoms and other measures of mental health, following withdrawal and during the intervention.

This pilot is the first intervention study to test off-label use of clomiphene citrate on AAS-dependent patients. If proven safe and effective, it may lead to physical, mental and social health benefits for users, and in long run, new treatment guidelines for AAS-dependence.