MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunstone Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are at least 18 years old
Are considered important to their well-being by patient participants (e.g., spouse or close family member)
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)
Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)
Disqualifiers
Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)
Weigh less than 48 kg
Condition impairing oral intake or digestive absorption
Are not able to give adequate informed consent
Trial design
Design model
Single group
Treatments tested in this trial
MDMA
DrugOn 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: MDMA-Assisted TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
The study will assess participants scores on The Adjustment Disorder New Module - 20 items (ADNM-20) from baseline to the primary time point (Visit 10, week 8 ± 2 days).
Time frame
8 weeks ± 2 days2
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
The study will assess participants scores on the Couples Satisfaction Index (CSI-16) scores from baseline to the primary time point (Visit 10, week 8 ± 2 days).
Time frame
8 weeks ± 2 daysSecondary outcomes
1
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 1)
Cancer patient: Edmonton Symptom Assessment System (ESAS)
Time frame
24 weeks2
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 2)
Cancer Patient: Pain Interference Scale (PIS)
Time frame
24 weeks3
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 3)
Cancer patient: Fatigue Assessment Scale (FAS)
Time frame
24 weeks4
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 4)
Cancer patient: MAC scale
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov