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