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

Part of paid clinical trials in Rockville, Maryland.

Sponsor
Sunstone Medical
Study ID
NCT05584826
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Adjustment Disorders
  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MDMA — DRUG
    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

Study 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.

Key Dates

Start date
Oct 6, 2022
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MDMA-Assisted Therapy
    Participants will receive 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.

Primary Outcome Measure

To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO. [ Time Frame: 8 weeks ± 2 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sunstone Medical, PCRockvilleMaryland20850
Study Contact
[email protected]
301-750-3401
Manish Agrawal, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Sunstone Medical, PC· Rockville, MD

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