HARM REDUCTION INTERVENTION FOR PEOPLE WHO USE ANABOLIC ANDROGENIC STEROIDS: THE RANDOMIZED CONTROLLED TRIAL

NCT07039539 | Not Yet Recruiting DMC

• 1 other identifier: 77455824.7.0000.0068
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is about harm reduction (HR) practices for peolple who use anabolic androgenic steroids. It is a randomized controlled trial (RCT) that will compare a group that will receive an intervention in HR and another control (CTRL) that will receive usual guidelines. The primary outcome is the reduction in the final amount of drug consumed in relation to the initial planned amount. The secondary outcome is the understanding of what made the participants change their beliefs and change the planned pattern of AAS consumption.

Conditions

Drug Abuse; Anabolic Steroids Adverse Reaction; Harm Reduction; Minimization, Harm

Keywords

human enhancement drug; performance and image enhancement drug; anabolic androgenic steroids; drug consumption; doping; harm reduction

Outcome Measures

Primary Outcomes (1)

• Modulation of drug use

  reduction in the total volume of drugs planned for the cycle compared to that used after the intervention (measured in milligrams of drugs)

  2 months

Secondary Outcomes (1)

• Decision-changing factors

  2 months

Study Arms (2)

Harm Reduction intervention

EXPERIMENTAL

Will receive health care based on harm reduction paradigma

Behavioral: Harm Reduction intervention

Control

NO INTERVENTION

Will receive regular and usual health care

Interventions

Harm Reduction intervention BEHAVIORAL

Care intervention guided by the harm reduction paradigm. Based on the acceptance of participants' needs as a starting point for constructing care responses. Guidance will be provided in collective meetings with information based on reliable scientific evidence and will support the construction of new knowledge and practices of mutual support.

Harm Reduction intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone over 15 years of age
• Planning to use AAS for aesthetic or performance purposes
• Planned use for a period of four months or more

You may not qualify if:

• Use for medical indication for hypogonadism, for example
• Use for sexual reassignment

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Substance-Related Disorders; Harm Reduction

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for performing interviews will be blinded to the allocation of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the Center for Lifestyle Medicine - School of Medicine of University of São Paulo

Model Details: Intervention (harm reduction practices) and control (usual practices)

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 10, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the analysis is completed
• Access Criteria: Having been a participant in the RCT

Locations

BR (1)