Safety and tolerability of inhaled N,N-Dimethyltryptamine (BMND01 candidate): A phase I clinical trial.

Psychedelics are being increasingly examined for their therapeutic potential in mood disorders. While the acute effects of ayahuasca, psilocybin, and lysergic acid diethylamide (LSD) last over several hours, inhaled N,N-Dimethyltryptamine (DMT) effects last around 10 min, which might provide a cost- and time-effective alternative to the clinical application of oral psychedelics. We aimed at investigating the safety and tolerability of inhaled DMT (BMND01 candidate). We recruited 27 healthy volunteers to receive a first, lower dose and a second, higher dose (5/20 mg, 7.5/30 mg, 10/40 mg, 12.5/50 mg, or 15/60 mg) of inhaled DMT in an open-label, single-ascending, fixed-order, dose-response study design. We investigated subjective experiences (intensity, valence, and phenomenology), physiological effects (blood pressure, heart rate, respiratory rate, blood oxygen saturation, body temperature), biochemical markers (liver, kidney, and metabolic functions), and adverse events during the acute and post-acute effects of DMT. DMT dose-dependently increased intensity, valence and perceptual ratings. There was a mild, transient, and self-limited increase in blood pressure and heart rate. There were no changes in safety blood biomarkers and no serious adverse events. DMT dose-dependently enhanced subjective experiences and positive valence. Inhaled DMT might be an efficient, non-invasive, safe route of administration, which might simplify the clinical use of this substance. This is the first clinical trial to test the effects of inhaled DMT (BMND01 candidate).

Úlcera de Marjolin: relato de 12 casos / Marjolin's ulcer: a twelve-case report

Relato de 12 casos de úlcera de Marjolin observados de 1990 a 2003 no HUCFF-UFRJ. Cinco pacientes do sexo feminino e sete do masculino, com idade variando de 38 a 86 anos. Tempo de evolução de 10 a 50 anos, da cicatriz até surgimento do carcinoma espinocelular. Ressecção da lesão em dois casos e amputação terapêutica em oito. Em um caso realizada exérese paliativa da lesão por apresentar metástase para coluna sacrococcígea. Um caso de impossibilidade terapêutica. Concluiu-se que a biópsia é essencial em úlceras crônicas, para diferenciar carcinoma espinocelular de hiperplasia pseudoepiteliomatosa.

The authors report twelve cases of Marjolin's ulcer that have been diagnosed between 1990 and 2003 at HUCFF-UFRJ. Five females and seven males, aged 38 to 86 years old, formed the group. Evolution time from scar to squamous cell carcinoma onset ranged from 10 to 50 years. Amputation was performed in eight cases and in one of them radiation therapy was associated. Two patients underwent local excision. One patient who already had spinal metastasis was submitted to palliative local excision. Finally, one case had no therapeutic possibilities. Early biopsy was concluded to be essential in chronic ulcers, to establish the difference between squamous cell carcinoma and pseudoepitheliomatous hyperplasia.