Psilocybin-assisted psychotherapy for methamphetamine use disorder: A pilot open-label safety and feasibility study

The abstract of this Lancet preprint reads: "Background: There are few effective treatments for methamphetamine use disorder, despite increasing global demand. Here, we assessed the safety and feasibility of outpatient psilocybin-assisted psychotherapy for methamphetamine use disorder.  Methods: We recruited 15 participants from a public stimulant treatment program and the community to this single arm, open label pilot study. Participants were ≥25 years old, seeking treatment for methamphetamine use, using methamphetamine ≥4 days/month at screening, and without serious mental illness or contraindicated medical conditions or medications. Participants received three preparatory psychotherapy sessions over two weeks before a single psilocybin dosing session (25mg oral), followed by two integration psychotherapy sessions over one week. Psychotherapy included elements of motivational enhancement and acceptance and commitment therapy. Participants were followed for 90 days post psilocybin-assisted psychotherapy session. Primary endpoints were safety and feasibility, and secondary endpoints included methamphetamine and other drug use, drug craving, depression, anxiety, stress and quality of life.  Outcomes: Fifty-six individuals were pre-screened. Of these, 16 progressed to screening and 15 were eligible and enrolled into the study. Fourteen participants completed the study intervention and 13 completed 90-day post-dose follow-up. No serious adverse events (AEs) occurred, and the seven treatment related AEs were self-limiting and mild to moderate in severity. AEs included hypertension during the dosing session and headache (n=4), nausea (n=1) and noise sensitivity (n=1) within the week following the dose. Methamphetamine use (over the prior 28 days) decreased from screening (median 12 days, IQR 7-16, n=15) to day 28 (median 0 days, IQR 0-2, n=13) and 90 (median 2 days, IQR 1-4, n=14) post psilocybin. Methamphetamine craving decreased while quality of life, depression, anxiety, and stress improved from baseline to day 28 and 90 follow-up.  Interpretation: Psilocybin assisted psychotherapy for methamphetamine use disorder was feasible to implement in an outpatient setting, did not appear to generate safety concerns, and demonstrated signals of effectiveness warranting further investigation."

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