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Synergy in Action

Developing Integrated Interventions: Clinical Trials for Drug/Neuromodulation – Psychotherapy Combinations

Chairs: Walter Dunn, MD, PhD, UCLA; Zimri Yaseen, MD, FDA CDER OND DPP

Recent years have seen a steady increase in the new applications of somatic therapies that target symptom change in interaction with psychotherapeutic interventions. Examples range from use of repetitive transcranial magnetic stimulation combined with symptom provocation for obsessive compulsive disorder, to intranasal oxytocin combined with social cognition training for young people with early psychosis, to use of MDMA to enhance non-directive psychotherapy grounded in psychodynamic principles to treat adults with post-traumatic stress disorder.

In clinical trials settings such integrated interventions pose a variety of technical and conceptual problems. These issues include:

• defining psychotherapy
• characterization of the psychotherapy component of an integrated intervention
• addressing potentially treatment-intrinsic functional unblinding (e.g., psychedelic psychotherapy)
• accounting for effects of integrated intervention components (e.g., 2×2 trial designs)
• accounting for psychotherapist effects
• evaluating distinctive or novel endpoints (e.g., extinction learning, intra-therapeutic process outcomes such as working alliance)
• distinctive needs in, limits on, and characteristics of regulation of medication-psychotherapy combinations

We are convening a Working Group to gather those who are currently investigating such integrated intervention approaches, to engage trialists who would like to investigate such approaches, and bring to the table those who are cautious or concerned about such approaches or their regulation, and begin an effort to better understand how integrated interventions can best be studied to support understanding of mechanisms, demonstrations of efficacy, and regulatory decision-making.

Deliverables

  • Whitepaper 1.5 years – to characterize critical issues and best practices for clinical trial design in the medication assisted psychotherapy domain
  • Peer reviewed journal article 2-2.5 years – parallel to whitepaper.

Inaugural Meeting will take place at the ISCTM 16th Annual Meeting, 19-21 February 2020. If working calls are conducted summer/fall 2019, a call for participation will be circulated to membership.