Debunking the myth of 'Blue Mondays': No evidence of affect drop after taking clinical MDMA.

BACKGROUND: Incorporating 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy has shown promise in recent years for treating various mental health conditions, particularly those involving trauma. However, concerns about declines in mood and cognition during the days following dosing, also known as 'Blue Mondays', have been raised as limitations to its clinical use. Although these changes have been well-documented among recreational users, there are critical confounds to these reports that limit generalizability to clinically administered MDMA. AIMS: Here, we aimed to evaluate the evidence basis for the negative side effects associated with MDMA as well as inform our understanding of the drug's post-acute effects in a clinical context with an open-label study. METHODS: The current open-label study examined MDMA therapy for alcohol use disorder (AUD; N = 14) and measured mood, sleep quality, illicit MDMA consumption and anecdotal reports after the acute drug effects had worn off. RESULTS: Participants maintained a positive mood during the week following drug administration in a clinical context. Relative to baseline, self-reported sleep quality improved at the 3- and 6-month follow-ups. Finally, no participants reported using or desiring to use illicit MDMA, and the anecdotal reports indicated that they perceived the treatment favourably. CONCLUSION: The results support the overall safety and tolerability of clinically administered MDMA and, importantly, suggest that the 'come downs' previously associated with the substance may be explained by confounds in research relating to the illicit sourcing of the drug and specific environmental setting for recreational consumption.

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder.

BACKGROUND: 3,4-methylenedioxymethamphetamine (MDMA) therapy has qualities that make it potentially well suited for patients with addictions, but this has never been explored in a research study. We present data from the Bristol Imperial MDMA in Alcoholism (BIMA) study. This is the first MDMA addiction study, an open-label safety and tolerability proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD). AIMS: This study aimed to assess if MDMA-assisted psychotherapy can be delivered safely and can be tolerated by patients with AUD post detoxification. Outcomes regarding drinking behaviour, quality of life and psychosocial functioning were evaluated. METHODS: Fourteen patients with AUD completed a community alcohol detoxification and received an eight-week course of recovery-based therapy. Participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Safety and tolerability were assessed alongside psychological and physiological outcome measures. Alcohol use behaviour, mental well-being and functioning data were collected for nine months after alcohol detoxification. RESULTS: MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the 'Outcomes' study) by the same team with a similar population of people with AUD. CONCLUSIONS: This study provides preliminary support for the safety and tolerability of a novel intervention for AUD post detox. Further trials to examine better the therapeutic potential of this approach are now indicated.

A Review of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy.

This paper provides a brief review of the history, proposed pharmacological mechanisms, safety issues, and clinical applications of the medicine 3,4-methylenedioxymethamphetamine (MDMA). Most clinical MDMA research in patients to date has focused on MDMA-assisted psychotherapy to treat posttraumatic stress disorder (PTSD). In this review paper other potential therapeutic applications for MDMA therapy are described, including contemporary studies treating anxiety associated with autism and the authors' ongoing study exploring the potential role for MDMA-assisted psychotherapy to treat alcohol use disorder. MDMA therapy for PTSD is now entering the final Phase 3 stage of drug development, with a target set for licensing by the FDA and EMA in 2021. This means that if clinical efficacy criteria are achieved, MDMA would become a medicine.

Illness perceptions in anorexia nervosa: a qualitative investigation.

OBJECTIVES: Anorexia nervosa (AN) is an eating disorder characterized by the egosyntonic nature of symptoms, denial of illness, and ambivalence about treatment engagement. Within the physical health literature, people's beliefs about their illness have been found to impact upon coping and treatment outcomes and this has largely been explored using the self-regulation model. This model has also been applied to mental health and more recently to AN, with beliefs about the disorder being associated with readiness to change. However, qualitative investigations have indicated that physical health models have limited applicability for assessing people's beliefs about mental illness. This may be particularly pertinent to AN, given the complexity of the disorder. Therefore, this study explored illness perceptions in AN using a qualitative design which was not restricted by a physical illness model but focused on personal models of AN from the perspective of those experiencing the disorder. DESIGN: Semi-structured interviews were conducted with thirteen participants who were currently in treatment for AN. METHOD: Interview transcripts were analysed using grounded theory methodology. RESULTS: An interpretative theory of illness perceptions in AN was developed and comprised four related categories: 'making sense of AN', 'the relationship between AN and the self', 'the recovery struggle', and 'coping with treatment'. CONCLUSION: Patient's accounts transcended the dimensions offered by physical illness models, with the implication that methods for assessing illness beliefs in AN require adaptation for a full understanding to be gained and the complexity of perceptions to be captured.