MDMA-assisted Therapy for Adjustment Disorder in Cancer Patients and Loved Ones
This study is exploring if MDMA-assisted therapy can help people with cancer and their close loved ones (called a Concerned Significant Other or CSO) who are experiencing Adjustment Disorder (AD). AD is a type of stress-related condition. The study will involve 20 participants (10 pairs of patients and CSOs) and will test the safety, how well people tolerate the treatment, and if it helps with AD and relationship issues. You would receive two doses of MDMA (a drug) along with therapy sessions over an 8-week period. The main goal is to see how well this treatment works for AD and relationship functioning after 8 weeks.
- Study design
- This is an open-label, single-site pilot study (Phase 2) involving 20 participants (10 pairs of patients and their loved ones). Open-label means everyone knows what treatment is being given.
- What's involved
- You would participate in an 8-week treatment period, which includes two doses of MDMA, two preparatory therapy sessions, and four integrative therapy sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- The effectiveness of the intervention will be measured at 8 weeks after the start of treatment.
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MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Manish Agrawal, MD · PRINCIPAL_INVESTIGATOR · Sunstone Medical, PC
Who to contact
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What this trial measures
- To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.8 weeks ± 2 days
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).
- To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.8 weeks ± 2 days
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).