Safety and risk assessment of psychedelic psychotherapy: A meta-analysis and systematic review.

Psychotherapies assisted by psychedelic substances have shown promising results in the treatment of psychiatric disorders. The aim of this systematic review and meta-analysis was to evaluate safety data in human subjects. We carried out a search on MEDLINE, Embase and PsycINFO databases between 2000 and 2022. Standardized mean differences between different dose ranges and between acute and subacute phases were calculated for cardiovascular data after psychedelic administration. Risk differences were calculated for serious adverse events and common side effects. Thirty studies were included in this meta-analysis. There were only nine serious adverse events for over 1000 administrations of psychedelic substances (one during the acute phase and 8 during the post-acute phase). There were no suicide attempts during the acute phase and 3 participants engaged in self-harm during the post-acute phase. There was an increased risk for elevated heart rate, systolic and diastolic blood pressure for all dose range categories, as well as an increased risk of nausea during the acute phase. Other common side effects included headaches, anxiety, and decreased concentration or appetite. This meta-analysis demonstrates that psychedelics are well-tolerated, with a low risk of emerging serious adverse events in a controlled setting with appropriate inclusion criteria.

Ecological momentary assessment in addiction.

Numerous symptoms in psychiatry are subjective (e.g., sadness, anxiety, craving or fatigue), fluctuate and are environment dependent. Accurate measurement of these phenomena requires repeated measures, and ideally needs to be performed in the patient's natural environment rather than in an artificial laboratory environment or a protected hospital environment. The usual paper and pencil questionnaires do not meet these two conditions for reasons of logistics. A recently developed method, ecological momentary assessment (EMA), made it possible to implement these field assessments via ingenious use of various devices (most frequently an electronic diary) coupling an auditory signal with computerized data capture. The subject carries the device with him/her at all times, and data is recorded in vivo in real time. The programming of repeated measures in the form of a Likert scale or pull-down menu is easily achieved. A recall alarm system can help increase compliance. Compared with classical self-report, EMA improves the validity of the assessment of certain symptoms, which are the main evaluation criteria in clinical trials concerning certain pathologies (e.g., craving and treatment of addiction), where measurement was previously liable to bias. This article sets out to present this method, its advantages and disadvantages, and the interest it presents in psychiatry, in particular via three original applications developed by the authors including: measurement of reaction time without the knowledge of the subject in order to test certain cognitive models; use of a graphic solution for the data recorded for functional analysis of disorders; and the use of data collection via mobile phone and text messages, which also enables therapeutic interventions in real time by text messages, personalized on the basis of the situational data collected (e.g., in the case of craving, the associated mood, solitary or group consumption or concomitant occupations).

An in vivo study of the relationship between craving and reaction time during alcohol detoxification using the ecological momentary assessment.

BACKGROUND: To study cognitive interference associated with craving for alcohol, the Ecological Momentary Assessment (EMA) method was used to measure the relationship between craving and reaction time. A secondary aim was the study of the predictive factors for craving during alcohol detoxification. The EMA enables both repeated measures of craving in a natural setting and the recording of reaction time without the patient being aware of this. METHODS: Craving for alcohol, reaction time, sadness and anxiety were recorded 8 to 12 times a day, over three weeks of detoxification in 14 alcoholics (n=1767 measures), on an electronic diary issuing random prompts. Mixed models were used for statistical analysis (alpha=5%, 1-beta=88%). RESULTS: Reaction time was significantly increased in univariate analysis when a craving episode occurred but this difference did not persist after multivariate analysis. Craving episodes were more frequent and intense than previously reported. Predictive factors of craving during detoxification were: age, gender, sadness, anxiety and the number of previous detoxifications. Antidepressants, anti-craving medications but not benzodiazepines were negatively associated to craving.