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Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n= 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P< 0.0001, d= 0.91) and to significantly decrease the SDS total score (P= 0.0116, d= 0.43). The mean change in CAPS-5 scores in participants completing treatment was −24.4 (s.d. 11.6) in the MDMA group and −13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.

Background: For structurally marginalized populations, including people who use drugs (PWUD), equitable access to healthcare can be achieved through healthcare access supports. However, few studies characterized utilization of formal (eg, outreach workers, healthcare professionals) and informal (eg, friends/family) supports. Therefore, we sought to estimate the prevalence of and factors associated with receiving each type of support among PWUD.Methods: We used data from 2 prospective cohort studies of PWUD in Vancouver, Canada, in 2017 to 2020. We constructed separate multivariable generalized linear mixed-effects models to identify factors associated with receiving each of the 3 types of supports (ie, healthcare professionals, outreach workers/peer navigators, and informal supports) compared to no supports.Results: Of 996 participants, 350 (35.1%) reported receiving supports in the past 6 months at baseline, through informal supports (6.2%), outreach workers (14.1%), and healthcare professionals (20.9%). In multivariable analyses, HIV positivity, chronic pain, and avoiding healthcare due to the past mistreatment were positively associated with receiving supports from each of healthcare professionals and outreach workers. Men were less likely to receive any types of the supports (all P< .05).Conclusions: Utilization of healthcare access supports was relatively low in this sample. However, formal supports appeared to have reached PWUD exhibiting more comorbidities and experiencing discrimination in healthcare. Further efforts to make formal supports more available would benefit PWUD with unmet healthcare needs, particularly men.

Conflictual evidence exists regarding the effects of cannabis use on the outcomes of opioid agonist therapy (OAT). In this exploratory analysis, we examined the effect of recent cannabis use on opioid use, craving, and withdrawal symptoms, in individuals participating in a trial comparing flexible buprenorphine/naloxone (BUP/NX) take-home dosing model to witnessed ingestion of methadone.