MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
Sunstone Medical
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Are at least 18 years old 2. Are considered important to their well-being by patient participants (e.g., spouse or close family member) 3. Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental disorder. Does not represent a normal bereavement) 4. Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale) 5. Are able to swallow pills. 6. Are willing to be driven home after the experimental sessions, either by a driver arranged by the participant or by the si…
Interventions
- DrugMDMA
On 2 separate treatment visits, participants will receive dosing of 100 mg MDMA HCl (\~84 mg MDMA) + 40 mg MDMA HCl (\~34 mg MDMA) supplement unless tolerability issues arise from the first dose or the participant declines
Location
- Sunstone Medical, PCRockville, Maryland