Scientific Concept Note — Part 2

Potential Assessment Timeline
1
Baseline or admission
2
30 days
3
60 days
4
90 days
5
Discharge
6
Three-month follow-up
7
Six-month follow-up
8
Twelve-month follow-up

The final schedule may be adapted according to treatment duration, institutional capacity and participant availability.

Potential Outcome Domains

Substance Use

Craving, relapse and continued recovery.

Mental Health

Depression, anxiety and psychological distress.

Psychological Functioning

Emotional regulation, flexibility and coping.

Quality of Life

Physical, emotional and social well-being.

Cognitive Functioning

Attention, memory, decision-making and executive functioning.

Social Reintegration

Family relationships, employment and community participation.

Spirituality and Meaning

Values, belonging, meaning in life and spiritual resources.

Treatment Engagement

Retention, adherence, participation and follow-up.

Proposed Data Collection

Data collection may combine validated questionnaires, structured interviews, institutional records, participant-reported outcomes and qualitative interviews. Digital systems may support symptom monitoring, follow-up and participant engagement. Digital tools should support, not replace, professional care or direct clinical assessment.

Qualitative Research

Qualitative interviews may provide insight into recovery experiences, identity reconstruction, relationships, stigma, spirituality, treatment engagement and barriers to long-term recovery. Analysis should follow transparent and scientifically appropriate methods.

Ethics and Participant Protection

  • ✦ Voluntary informed consent
  • ✦ Right to withdraw
  • ✦ Protection from coercion
  • ✦ Confidentiality and data minimization
  • ✦ Secure data storage
  • ✦ Protection of vulnerable participants
  • ✦ Independent ethical review
  • ✦ Clear professional responsibilities
  • ✦ Respect for cultural and religious diversity

Data Governance

The project should establish clear rules for data ownership, access, anonymization, storage, retention, analysis, authorship and publication. Brazilian institutions and professionals should participate in study governance, interpretation and scientific dissemination.

International Collaboration

Potential partners may contribute to study design, methodology, validated instruments, statistics, data management, ethics, neuroscience, neuropsychology, addiction medicine and cross-cultural analysis. Brazil should be treated as an active scientific partner and not merely as a participant-recruitment location.

International Collaboration

Future Research Perspective

The Observatory may create a scientific foundation for future research on preparation, integration, psychological mechanisms and psychedelic-assisted approaches. No interventional psychedelic research is included in the initial observational project. Any future study involving psychedelic substances would require qualified medical and academic leadership, ethical approval, regulatory authorization, suitable infrastructure and participant protection.

Potential Scientific Outputs

  • ✦ Feasibility report
  • ✦ Baseline population profile
  • ✦ Longitudinal outcome analyses
  • ✦ Relapse and adherence studies
  • ✦ Qualitative publications
  • ✦ Cross-cultural studies
  • ✦ Conference presentations
  • ✦ Professional training materials
  • ✦ Future multicenter proposals

Proposed Development Phases

1
Partner Identification

Academic, clinical and community partners.

2
Protocol Development

Objectives, methods, instruments and governance.

3
Ethical Review

Formal submission before recruitment.

4
Pilot Implementation

Training, data collection and follow-up.

5
Analysis and Publication

Interpretation, dissemination and future development.

Invitation to Scientific Dialogue

PSICODELIX welcomes dialogue with universities, hospitals, researchers, foundations and institutions interested in addiction recovery, community mental health, longitudinal research and cross-cultural cooperation.

The immediate objective is to refine the concept, identify qualified partners and develop a realistic pilot protocol.

Contact for Institutional Collaboration