6.1.4 Psychedelic-assisted psychotherapy (PAP)
The role of psychedelic-assisted psychotherapy (PAP) is another important methodological concern in future trial design regarding investigations for chronic pain and OUD. Despite concomitant psychotherapy being a component of other modern trials of psilocybin for other SUDs,14,130 protocols have included mostly manualized cognitive behavioral therapy- or motivational enhancement therapy-based interventions. The efficacy for evidence-based psychosocial treatments for chronic pain131 and substance use132 remain modest, with small to medium effect sizes across trials. As such, adjunctive psychedelics may increase the efficacy and/or engagement in evidence-based psychosocial treatments. The importance of psychotherapy during these psychedelic trials on efficacy remains to be seen as there are exist few repeated evaluations or studies have not been powered to assess differences between groups on psychotherapy. Draft FDA guidance on psychedelic trials has also questioned the use of PAP as it raises concerns about standardization and the introduction of other forms of bias. The many types of PAP have been reviewed in detail, including discussions on trial design during each phase of psychedelic trial,133,134 as have theoretical considerations for its use in other components of recovery and synergy with other treatment paradigms such as twelve-step facilitation (TSF).135