Clinical Trial Participant and Clinician Experience in a Phase 2 (US-only) Trial of MM120 for Generalized Anxiety Disorder
Author(s)
Dawn Bates, BS, MBA, MS1, Phong Duong, BSc, PharmD2, Stephanie Loomer, MS3, Michelle Matvey, BS4, Sarah Karas, PsyD4, Paula Jacobsen, PhD4, Jamie Freedman, BA4, Erin Ferries, PhD, MPH4, Jamileh Jemison, PhD4, Zander Pittman, BS3, Kathleen Beusterien, BS, MPH3.
1Senior Evidence Generation Lead, Oracle Life Science, Webster, NY, USA, 2MindMed, New York, NY, USA, 3Oracle Life Sciences, Austin, TX, USA, 4Mind Medicine, Inc., New York, NY, USA.
1Senior Evidence Generation Lead, Oracle Life Science, Webster, NY, USA, 2MindMed, New York, NY, USA, 3Oracle Life Sciences, Austin, TX, USA, 4Mind Medicine, Inc., New York, NY, USA.
Presentation Documents
OBJECTIVES: Patient voice throughout product development is invaluable. Such perspective is limited for psychedelic treatment and individuals with generalized anxiety disorder (GAD). This research sought to capture perceptions of clinical trial experiences for participants with GAD, early in product development.
METHODS: This qualitative study sought to obtain insights from site clinicians and individuals with GAD who participated in a placebo-controlled phase 2b trial of a single dose of lysergide D-tartrate (MM120) for treatment of GAD. One-on-one interviews were conducted by a trained moderator with site clinicians (n=10) and clinical trial participants (n=32) receiving therapeutic doses or placebo. The moderator guided all respondents through a discussion of the trial experience using a clinical trial timeline graphic to facilitate the conversation and enhance recall. For trial participants, a homework exercise was completed prior to the interview to understand the impact of GAD, and a projective technique was used during the interview to elicit the emotional impact of their trial experience. Thematic analysis of transcripts was performed using MAXQDA software.
RESULTS: Key themes identified included difficulty stopping select current medications before and during the trial, stigma associated with psychedelics, lexicon used in describing psychedelics, approaches to improve participant comfort and setting expectations, and limitations of eligibility criteria. All respondents noted anxiety about the prospect of receiving placebo, and clinicians noted disappointment for those given placebo. The projective technique with participants elicited a spectrum of emotions regarding the trial journey, including initially feeling fragile or tense, and proceeding to feeling calm, having a reset, healing, clarity and lightness.
CONCLUSIONS: This research outlines a successful strategy for soliciting input regarding clinical trial participant experiences. Projective techniques and visual stimuli worked well to gain a holistic picture of the participant’s experience, including difficult-to-quantify emotional experiences. These insights may provide practical solutions to improving psychedelic clinical trials.
METHODS: This qualitative study sought to obtain insights from site clinicians and individuals with GAD who participated in a placebo-controlled phase 2b trial of a single dose of lysergide D-tartrate (MM120) for treatment of GAD. One-on-one interviews were conducted by a trained moderator with site clinicians (n=10) and clinical trial participants (n=32) receiving therapeutic doses or placebo. The moderator guided all respondents through a discussion of the trial experience using a clinical trial timeline graphic to facilitate the conversation and enhance recall. For trial participants, a homework exercise was completed prior to the interview to understand the impact of GAD, and a projective technique was used during the interview to elicit the emotional impact of their trial experience. Thematic analysis of transcripts was performed using MAXQDA software.
RESULTS: Key themes identified included difficulty stopping select current medications before and during the trial, stigma associated with psychedelics, lexicon used in describing psychedelics, approaches to improve participant comfort and setting expectations, and limitations of eligibility criteria. All respondents noted anxiety about the prospect of receiving placebo, and clinicians noted disappointment for those given placebo. The projective technique with participants elicited a spectrum of emotions regarding the trial journey, including initially feeling fragile or tense, and proceeding to feeling calm, having a reset, healing, clarity and lightness.
CONCLUSIONS: This research outlines a successful strategy for soliciting input regarding clinical trial participant experiences. Projective techniques and visual stimuli worked well to gain a holistic picture of the participant’s experience, including difficult-to-quantify emotional experiences. These insights may provide practical solutions to improving psychedelic clinical trials.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR11
Topic
Patient-Centered Research
Topic Subcategory
Patient Behavior and Incentives, Patient Engagement
Disease
SDC: Mental Health (including addition)