This clinical trial aims to investigate the short and long-term efficacy of a harm reduction intervention in reducing the use of non-clinical anabolic-androgenic steroids (AAS) in abusive users of AAS. As secondary objectives, the study will investigate the intervention's effect on health parameters (i.e., blood), quality of life, sleep quality, body image, eating behavior, depression, anxiety, fatigue, aggressiveness, cardiovascular parameters, muscle strength, body composition and muscle cross-sectional area outcomes.
Anyone over 15 years of age;
Planning to use/increase the dose of AAS for aesthetic and/or physical performance purposes;
Plan to use/increase the dose of AAS during eight to twelve weeks.
Medical prescription for AAS use;
Use for sexual reassignment.
Parallel
harm reduction intervention in non-clinical anabolic-androgenic steroids users
BehavioralParticipants will receive four structured counseling sessions, each lasting up to 30 minutes. Utilizing a non-judgmental harm reduction framework, these sessions aim to reduce substance abuse and address associated health risks. The intervention is person-centered, tailoring discussions to the user's specific needs and questions regarding their health and the use of non-clinical anabolic-androgenic steroids (AAS).
Long-term reduction of the anabolic-androgenic steroids utilized
The primary outcome is the change in total anabolic- androgenic steroids (AAS) utilized (i.e., expressed in mg) compared to the initial plan (i.e., planned AAS amount for the self-conducted use) in the long-term (i.e., one year after the cycle's end).
Short-term effects on cumulative use of anabolic-androgenic steroids and short- and long-term effects on general health parameters
General health parameters will be assessed through a comprehensive blood panel analyzing endocrine (TSH, free T3, free T4, IGF-1, LH, FSH, estradiol, SHBG, total testosterone, prolactin, inhibin B, adiponectin, cortisol, oxytocin, DHEA), metabolic (HDL, triglycerides, VLDL, LDL, ApoB, glucose, insulin, C-peptide), hematological/inflammatory (iron, ferritin, hemoglobin, hematocrit, coagulation profile, D-dimer, fibrinogen, CRP, ESR, IL-6, IL-1B, IL-10, TNF-α), renal/hepatic (urea, electrolytes, creatinine, creatinine clearance, CK, bilirubin, ALT, AST, alkaline phosphatase, GGT, LDH), and infectious disease (HIV, hepatitis B, hepatitis C) biomarkers.
Short-term and long-term effects on cumulative use of anabolic-androgenic on quality of life and sleep quality
Quality of life will be measured by the Short Form-36 Health Survey (SF-36) (Lyons et al., 1994), with analysis focused on the physical component summary and mental component summary scores; and sleep quality will be evaluated using the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index (Bertolazi et al., 2011), with the primary outcome being the global score (0-21 points);
Short-term and long-term effects on cumulative use of anabolic-androgenic on body image
Issues related to body image will be assessed through the following questionnaires: Muscle Based Silhouette Measure (MSM) for men (Frederick et al., 2007) and Body Image Matrix of Thinness and Muscularity for women (Steinfeld et al., 2020), Male Body Checking Questionnaire (MBCQ) for men (Hildebrandt et al., 2009), Body Checking Questionnaire (BCQ) for women (Campana et al., 2013), Muscle Dysmorphic Disorder Inventory (MDDI) for women (Nagata, et al., 2021) and MDDI for men (Gomes et al, 2020).
Short-term and long-term effects on cumulative use of anabolic-androgenic on eating behavior
Eating behavior will be assessed through three questionnaires: The Muscularity-Oriented Eating Test (Carvalho et al., 2022) and Eating Pathology Symptoms Inventory (EPSI) (Forbush et al., 2013).
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