An interventional study of harm reduction intervention in non-clinical anabolic-androgenic steroids users in Drug Abuse, Harm Reduction and Minimization, Harm, sponsored by University of Sao Paulo. Not yet recruiting at 1 site in Brazil. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Supportive care
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.
Scientific Context and Rationale:
The abusive use of anabolic-androgenic steroids (AAS) for aesthetic and physical performance enhancing purposes (i.e., non-clinical) is a global problem that negatively affects the health of men and women of various age groups. In fact, the World Drug Report reinforced the concern about the non-clinical use of these drugs (World Drug Report, 2023). It is estimated that the global prevalence of AAS use is 6.4% and 1.6% among physically active men and women (Sagoe et al., 2014), respectively, and can reach 30% in bodybuilding gyms (Abrahin et al., 2014).
In short, AAS are synthetic substances similar to the hormone testosterone and are part of the list of performance and image enhancing drugs (PIED). The AAS promotes androgenic effects, such as spermatogenesis, deepening of the voice, increased libido, and changes in mood, along with anabolic effects, such as greater synthesis and lower protein degradation, and increased lipolytic activity. However, the abusive and prolonged use of AAS can negatively affect several health parameters. For example, AAS users are more prone to arrhythmias and sudden death, elevated mean arterial pressure over 24 hours, increases in the amount of calcium in the coronary arteries, and volume of atheromatous plaques (Baggish et al., 2017) . Additionally, the use of high concentrations of AAS (i.e., ≥ 200 mg per week) is associated with decreased endogenous testosterone production, spermatogenesis, and gonadal atrophy (Nieschlag \& Vorona, 2015). The seriousness of this global problem is aggravated when we consider that 32% of abusive users develop addiction (Pope, Kanayama, et al., 2014).
It is important to emphasize that the investigation of the effects of AAS abuse in health parameters is not methodologically trivial. The conduct of randomized and controlled studies is not possible because the obvious ethical impossibility of prescribing such substances to healthy humans, especially in the use schemes that are seen in the real world, which combine several drugs (a technique known as polypharmacy) in supraphysiological doses and in a chronic manner. In addition, as described, the use of AAS affects several systems in the human body, which requires a multidisciplinary evaluative approach. As a result, the current evidence on the damage caused to health by AAS is mostly of low scientific quality, and comes from cross-sectional studies, retrospectives, case studies, and opinion articles. Together, the conduction of better quality studies are needed in order to increase understanding about harm reduction strategies for abusive users. In this scenario, prospective cohort studies involving individuals planning to self-conduct the use of AAS emerge as an ethically viable and methodologically appropriate option for investigating the topic. (Bonnecaze et al., 2021; Rops et al., 2022)
Despite the advances achieved by prospective cohort studies with habitual users of AAS, several gaps remain regarding the development of harm reduction interventions in this population. Briefly, the harm reduction strategy aims to decrease and/or cease the use of AAS in the long term. However, it is worth noting that ceasing the use of these drugs is extremely complex, as most users are affected by post-use withdrawal syndrome, which is characterized by symptoms of depression, a sharp drop in libido, and anhedonia, which stimulates the continuous and recurrent use of AAS. Therefore, harm reduction also aims to guide the user to (i) reduce the frequency and dose of AAS, (ii) minimize health complications due to the misuse of additional substances and/or contaminated material, and (iii) provide specialized multidisciplinary support for long-term monitoring of health parameters. Thus, controlled clinical trials aimed at evaluating new strategies to minimize the harm caused by the abusive use of AAS are urgent (Anawalt , 2019; Bonnecaze et al., 2021; Pope, Wood, et al., 2014).
Study Justification and Objective:
Given the ethical constraints of conducting interventional studies that involve administering supraphysiological anabolic- androgenic steroids (AAS) doses to healthy individuals, there is a need for research that engages directly with current AAS users in their real-world context. Therefore, this study is designed to investigate the feasibility and impact of a harm reduction intervention specifically developed to habitual AAS users.
General objective: to investigate the efficacy of harm reduction intervention in reducing the short and long-term use of non-clinical AAS use in habitual and abusive users. Secondary objectives include evaluating the intervention's impact on health parameters (i.e., blood and cardiovascular variables), quality of life, sleep quality, body image, eating behavior, depression, anxiety, fatigue, aggressiveness, muscle strength and body composition outcomes.
Study Population:
This randomized controlled trial (RCT) will recruit anabolic-androgenic steroids (AAS) habitual users, who declare the intention to self-administrate AAS for aesthetic and physical performance enhancing purposes.
In total, 32 participants will be recruited and randomly assigned into either the harm reduction intervention (HR) (n = 16) or the control (CTRL) group (n = 16). The sample size was calculated based on a previous study (Veerdegaal et al., 2026) which investigated the effect of a harm reduction intervention on the total AAS amount utilized compared to the initial plan, reflecting the expected longitudinal interaction between the intervention and control groups on cumulative anabolic steroid exposure. This effect size was computed using the Morris'd method for pretest-posttest control group designs, which standardizes the between-group difference in change scores using the pooled baseline standard deviation to account for initial imbalance (Morris, 2008). The resulting standardized mean difference (Morris d = -1.167) was converted to Cohen's f (f = 0.584) for use in ANOVA-based sample size estimation. Under a repeated-measures framework with four assessments, a two-sided alpha of 0.05, and 90% power, the calculated minimum sample size was 8 participants. However, this estimate was conservatively increased by a factor of four to account for the high dropout rates reported in the Veerdegaal (2026) study (53.9% in the harm reduction group and 45% in the historical control group), as well as to improve the sensitivity and robustness of the statistical analyses. Given the very large effect size observed, this inflation strategy also aims to mitigate potential overestimation of effects, enhance the precision of estimates for secondary and exploratory outcomes.
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 long-term (one year after the cycle's end). As for secondary outcomes, the current study will evaluate the harm reduction intervention effects on health parameters (i.e., blood and cardiovascular variables), quality of life, sleep quality, body image, eating behavior, depression, anxiety, fatigue, aggressiveness, muscle strength and body composition in the short (i.e., 8 weeks from AAS's cycle onset) and long-term (i.e., one year after the AAS's cycle end).
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 32 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants will undergo health exams at specific time points: T0 (before the start of the anabolic-androgenic steroids cycle), T0.5 (4 weeks into the cycle), and T1 (8 weeks into the cycle) and T2 (one year after T1).
Participants will undergo health exams and complete the research questionnaires at time points T0, T0.5, T1 and T2. Additionally, every 15 days between T0 and T1, the harm reduction intervention will attend 30 minutes long counseling sessions with the research team. These brief counseling sessions are based on a technique known as "Brief Intervention", which focuses on the participant's needs and discussion of health exams results.
Behavioral: harm reduction intervention in non-clinical anabolic-androgenic steroids users
Participants 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).
Time frame: One year after the end of the AAS cycle.
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.
Time frame: Eight weeks after AAS cycle's onset (short-term) and one year after the end of the AAS cycle (long-term)
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);
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
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).
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
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).
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
Short-term and long-term effects on cumulative use of anabolic-androgenic on depression, anxiety, fatigue and aggressiveness
To assess the severity of depressive episodes, the Beck Depression Inventory will be used (Richter et al., 1998). To evaluate anxiety symptoms, the Beck Anxiety Inventory (BAI) will be applied (Beck et al., 1988). For the assessment of fatigue, the Fatigue Severity Scale (FSS) (Toledo et al., 2011) and the Chalder Fatigue Questionnaire (Cho et al., 2007) will be used. To assess aggressiveness, the reduced version of the Buss-Perry Aggression Questionnaire (AQ-R) (Paiva et al., 2020) will be used.
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
Short-term and long-term effects on cumulative use of anabolic-androgenic on cardiovascular parameters
Cardiovascular health will be assessed through four complementary examinations: (1) Endothelial Function: evaluated by the flow-mediated dilation (FMD) technique; (2) Resting Electrocardiogram: recorded with 12 simultaneous leads; and (3) Cardiopulmonary Exercise Test (ergospirometry): conducted on a cycle ergometer to determine maximal aerobic capacity.
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
Short-term and long-term effects on cumulative use of anabolic-androgenic on muscle strength
Muscle strength will be assessed through (a) lower-limb strength, measured by a 5-second maximum voluntary contraction (MVC) for the right leg, and (b) upper-limb strength, assessed by handgrip dynamometry on the right arm.
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
Short-term and long-term effects on cumulative use of anabolic-androgenic on body composition and muscle cross-sectional area
body composition (lean mass, fat mass, and fat percentage) will be assessed via dual-energy X-ray absorptiometry (DXA). Muscle cross-sectional area will be assessed by rectus femoris and vastus lateralis cross-sectional area from the right thigh utilizing B-mode ultrasonography with a linear transducer.
Time frame: Eight weeks after AAS cycle's onset and one year after the end of the AAS cycle.
Plan to share: Yes — The results produced will be shared as requested by participants. All those who wish to be included will be included in a specific category in publications where this is possible.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: After the analysis is completed
Access criteria: Having been a participant in the RCT
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jan 2028, 17 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 17 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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