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

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Trial Identification

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

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

Study ID: NCT05584826

Conditions

Cancer

Adjustment Disorders

Interventions

MDMA

Study Description

Brief Summary: 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.

Detailed Description: This open-label single site concurrent mixed-method phase 2 pilot trial will assess the 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). The intervention will include two doses of MDMA, administered during the Treatment Period with manualized therapy. This 8-week Treatment Period includes two Preparatory Sessions and four Integrative Sessions of non-drug therapy.