Medication (and brain stimulating device) Assisted Psychotherapy Clinical Trials
Chairs: Walter Dunn, MD, PhD, UCLA; Zimri Yaseen, MD, FDA CDER OND DPP
Objective: The aim of this working group is to develop a better understanding of the scientific and regulatory issues affecting clinical trial design for treatments meant to rely on the combination of medication with psychotherapy, with the aim of developing guidance for appropriate trial design to support development and approval of medications intended to be used in combination with or as enhancers of psychotherapies.
These issues include:
- potentially treatment-intrinsic functional unblinding (e.g., psychedelics)
- distinctive endpoints such as intra-therapeutic process outcomes (e.g., extinction learning, working alliance formation)
- characterization of psychotherapy component of treatment
- clinical trial design- 2×2
- accounting for psychotherapist effects
- accounting for psychotherapy effects
- distinctive needs in, limits on, and characteristics of regulation of medication-psychotherapy combinations
- 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.