MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other

This open-label single-group assignment trial (n=20) aims to evaluate the feasibility, tolerability, and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of cancer patients and their concerned significant others (CSOs).

Led by Sunstone Medical, the trial will span an 8-week treatment period, involving two doses of MDMA along with manualized therapy sessions, including two preparatory sessions and four integrative sessions of non-drug therapy. The intervention seeks to assess the impact on adjustment disorder and relationship functioning.

Participants, aged 18 and above, must meet DSM-5 criteria for current AD and be considered important to the well-being of the patient participants. The primary outcome measures include assessing participants’ scores on The Adjustment Disorder New Module – 20 items (ADNM-20) and the Couples Satisfaction Index (CSI-16) from baseline to week 8 ± 2 days. Secondary outcome measures encompass various psychological distress, mental adjustment to cancer, relationship functioning, and health-related quality of life scales.

Participants will receive two doses of MDMA during the treatment period, with dosing based on participant tolerance. Recruitment is ongoing, and the estimated completion date is December 2024.

Topic Relationships Palliative Care
Compound MDMA
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 06 October 2022
End date 31 December 2024
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18-
Therapy Yes

Trial Details

The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total). Participants will undergo an 8-week treatment period which will include two doses of MDMA, two Preparatory Sessions and four Integrative Sessions of non-drug therapy.

NCT Number NCT05584826

Sponsors & Collaborators

Sunstone Therapies
Sunstone Therapies is dedicated to the development and implementation of innovative therapies for individuals affected by cancer and other conditions.

Data attribution

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