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BMJ Open

ISSN 2044-6055

12 papers in the library · 172 citations · publishing 2017-2026

Papers

Does psychedelic drug use reduce risk of suicidality? Evidence from a longitudinal community-based cohort of marginalised women in a Canadian setting

BMJ Open September 1, 2017 Elena Argento, Steffanie A. Strathdee, Kenneth W. Tupper et al. 60 citations

Among marginalised women in Vancouver, those who had ever used a psychedelic drug showed a 60% lower hazard of developing suicidal ideation or attempts over 54 months, after adjusting for other factors. Crystal methamphetamine use tripled the hazard, and childhood abuse more than tripled it. Nearly half of the 766 women had prior suicidality and were excluded; among the 290 without it at baseline, 11% developed suicidality during follow-up, an incidence of 4.42 per 100 person-years. The findings suggest naturalistic psychedelic use may have a protective association, while other illicit drug use and childhood trauma increase risk.

Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial

BMJ Open December 1, 2021 James Rucker, Hassan Jafari, Tim Mantingh et al. 23 citations

A randomized, placebo-controlled trial is testing the feasibility of psilocybin-assisted therapy for people with major depressive disorder who have not responded to at least two prior treatments. Up to 60 participants in London, UK receive either 25 mg psilocybin or a placebo in a single dosing session, along with psychological therapy. The primary outcomes are recruitment rates, dropout rates, and variance in depression scores measured by the Montgomery Asberg Depression Rating Scale at 3 and 6 weeks. The trial also collects neuroimaging and omics data and offers an open-label extension dose of psilocybin.

Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)

BMJ Open October 1, 2022 Mathias Ebbesen Jensen, Dea Siggaard Stenbæk, Tobias Søgaard Juul et al. 21 citations

A planned clinical trial will test whether psilocybin-assisted therapy, compared to a placebo, reduces heavy drinking in people with alcohol use disorder. Ninety treatment-seeking adults aged 20–70 will be randomly assigned to receive either psilocybin or placebo alongside psychological support. The main outcome is the change in percentage of heavy drinking days from baseline to 12 weeks after dosing. Secondary outcomes include total alcohol consumption, a blood biomarker for alcohol, the active drug metabolite in blood, the subjective drug experience, and brain responses to alcohol cues measured with functional MRI one week after dosing. The trial is registered and has ethical approval.

Mixed-methods evaluation comparing the impact of two different mindfulness approaches on stress, anxiety and depression in school teachers.

BMJ Open July 4, 2019 21 citations

A mixed-methods evaluation compared the impact of two different mindfulness approaches on stress, anxiety, and depression in school teachers. The study assessed which approach was more effective in reducing these negative outcomes. The findings indicate that both mindfulness approaches led to reductions in stress, anxiety, and depression among teachers, but the specific comparative effectiveness between the two approaches is not detailed in this abstract. The qualitative component provided insights into teachers' experiences with the interventions.

Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD

BMJ Open May 1, 2023 Alan K Davis, Adam W Levin, Paul B Nagib et al. 19 citations

Psilocybin-assisted therapy may help treat post-traumatic stress disorder (PTSD), which current treatments often fail to relieve, especially in U.S. military veterans. This open-label pilot study will test two psilocybin doses (15 mg and 25 mg) combined with psychotherapy in 15 veterans with severe, treatment-resistant PTSD. The primary safety outcome tracks adverse events and suicidal ideation; the primary PTSD outcome uses the Clinician Administered PTSD Scale-5. Follow-up continues for 6 months after the second session. Results will be published in a peer-reviewed journal.

UK medical students’ self-reported knowledge and harm assessment of psychedelics and their application in clinical research: a cross-sectional study

BMJ Open March 1, 2024 Charlie Song-Smith, Edward Jacobs, James Rucker et al. 9 citations

Most UK medical students (83%) are aware of psychedelic research and only 3% are not interested in learning more, yet only 17% feel well-educated on the topic. Students' harm assessments of psychedelics closely match experts', but teaching on psychedelics is rare in their curriculum. Time in medical school does not correlate with more knowledge about psychedelics. On average, students strongly support changing the legal status of psychedelics to enable further clinical research. Greater knowledge, lower perceived harm, more years in medical school, and lower perceived effectiveness of non-pharmacological mental health treatments are associated with stronger support for legal change.

Cost-effectiveness of providing university students with a mindfulness-based intervention to reduce psychological distress: economic evaluation of a pragmatic randomised controlled trial.

BMJ Open November 23, 2023 7 citations

Providing university students with a mindfulness-based intervention to reduce psychological distress is not cost-effective compared with usual support, according to an economic evaluation of a pragmatic randomised controlled trial. The intervention was more costly and produced no significant improvement in quality-adjusted life years or psychological distress outcomes, suggesting it does not represent good value for money.

Influence of low-dose esketamine on postoperative depressive symptoms in patients with breast cancer (EASE): study protocol for a randomised controlled trial

BMJ Open September 25, 2023 Cen Chen, Qingfeng Wei, Jiajia Zhu et al. 7 citations

A planned trial will test whether a low dose of the anesthetic esketamine, given before and during surgery, reduces depressive symptoms in women with breast cancer who are undergoing radical mastectomy. The study will randomly assign 108 women with mild-to-severe depression to receive either esketamine or a saline placebo. The main outcome is the proportion of patients whose depressive symptoms improve by the third day after surgery. The study also will measure changes in a brain protein called brain-derived neurotrophic factor and in resting-state brain connectivity, aiming to uncover how esketamine might work.

Evaluating the attitudes of mental health professionals towards trials of MDMA: a randomised vignette trial

BMJ Open November 26, 2022 Nick Glozier, Ben Colagiuri, Dean J Wright 3 citations

Mental health professionals' attitudes toward a trial of MDMA-assisted psychotherapy did not differ overall from their attitudes toward a neutrally labeled pharmacotherapy trial. Psychiatrists were less willing to recommend participation in the MDMA-AP trial than in the control trial. Psychologists and researchers showed no differences. More experienced professionals had greater concern and stronger objections to the MDMA-AP trial than less experienced ones. The findings suggest that certain mental health professionals, particularly experienced psychiatrists, may be hesitant about MDMA-AP, which could pose barriers to its research and implementation.

Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial: protocol for an open-label pilot trial for cancer-related bereavement

BMJ Open April 1, 2025 Vanessa L. Beesley, Tom Kennedy, Fiona Maccallum et al. 2 citations

Prolonged grief disorder (PGD) affects up to 30% of bereaved carers in oncology settings, and current treatments fail up to half of participants. The PARTING trial is the first to test psilocybin-assisted psychotherapy for cancer-related PGD. In this open-label pilot, about 15 participants receive a 25 mg dose of psilocybin with supportive guidance, plus preparation and integration sessions delivered by a psychologist and a nurse or Indigenous Therapist. Feasibility, safety, and acceptability are assessed through recruitment rates, adverse events, physiological measures, and qualitative interviews. Quantitative measures include grief severity, depression, anxiety, and quality of life over a 12-month follow-up.

MDMA-assisted PTSD and Alcohol Therapy Trial (MPATHY): study protocol for a double-blind, randomised, controlled outpatient trial of MDMA-assisted integrated exposure-based therapy for comorbid post-traumatic stress disorder and alcohol use disorder

BMJ Open July 1, 2026 Kirsten C. Morley, S Arunogiri, Katherine L. Mills et al.

Combining MDMA with an integrated exposure-based therapy may improve outcomes for people with both post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD), a comorbidity where standard treatments help only about half of patients. This double-blind trial will randomly assign 100 participants to receive either MDMA (80–160 mg) or an active control (niacin 250 mg) alongside 12 sessions of Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE). The primary PTSD outcome is the clinician-administered PTSD Scale for DSM-5; the primary drinking outcome is heavy drinking days per week, validated by phosphatidylethanol. Secondary measures include depression, sleep disturbances, adverse events, and cost-effectiveness. Results will provide first data on safety, efficacy, and cost-effectiveness of MDMA-augmented therapy for this comorbidity.

The Montreal model of ketamine-therapy for alcohol use disorder and comorbid treatment-resistant depression: protocol for a feasibility trial

BMJ Open March 1, 2026 Christina Mcanulty, Philippe Lavoie, Samuel Cyr et al.

A new treatment combining ketamine infusions with acceptance and commitment therapy (ACT) may be feasible for people who have both alcohol use disorder and treatment-resistant depression. In an open-label trial at a Montreal hospital, 30 participants will receive six ketamine infusions plus eight weekly therapy sessions, either in person or online. The study primarily tests whether the combined approach is practical and acceptable by measuring completion rates, safety, and data quality. Exploratory measures will track changes in depressive symptoms, alcohol use, and quality of life. Some participants will also be interviewed about their experiences.