Tijs Johannes Verdegaal, Willem de Ronde, M. Jansen, Peter Bond, Diederik L. Smit
OBJECTIVE: Androgen abuse for performance- and image-enhancement is increasing despite preventive efforts, yet no controlled trials have evaluated harm reduction strategies. This trial assessed whether a harm reduction intervention could reduce androgen abuse in males. DESIGN: Historically controlled trial. METHODS: This 1-year prospective intervention study included 99 male amateur athletes planning to start an androgen cycle. Outcomes were compared to a historical cohort study (n = 100) from our research group receiving no intervention. The intervention comprised individualized counseling and medical assessments. Primary outcomes included cumulative androgen dose, cycle duration, and weekly dosage. Secondary outcomes included within-participant deviation from planned abuse. RESULTS: Baseline characteristics were largely comparable, although intervention participants reported slightly more weekly training time and lower intended cumulative cycle dose. Twelve percent refrained from initiating a cycle due to the intervention. The mean cumulative androgen dose was 13 087 (95% CI -16 564 to -9609) mg lower in the intervention group (6323 ± 5229 mg) compared to controls (19 410 ± 16 497 mg). Within-person differences showed an average reduction of 8729 (95% CI -11 297 to -6287) mg in the intervention group compared to controls. Multivariable regression confirmed that the interventions' effect was independent of baseline differences. No significant enabling effect was observed. CONCLUSION: This is the first controlled study to demonstrate that a harm reduction intervention can reduce androgen exposure among men planning to abuse androgens. These findings support harm reduction as a promising strategy to mitigate health risks associated with androgen abuse. Future studies should confirm generalizability and monitor for potential enabling effects. CLINICAL TRIAL REGISTRATION NUMBER: Registration number P2117, study number NL77191.028.21.