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

Sunstone Medical1 site in 1 country20 target enrollmentOctober 6, 2022

ConditionsCancer Adjustment Disorders

InterventionsMDMA

DrugsMDMA

Overview

Phase: Phase 2
Intervention: MDMA
Conditions: Cancer
Sponsor: Sunstone Medical
Enrollment: 20
Locations: 1
Primary Endpoint: To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 6, 2022

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sunstone Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)
•Are able to swallow pills.
•Are willing to be driven home after the experimental sessions, either by a driver arranged by the participant or by the site personnel or taxi and agree not to drive after each Experimental Session until the therapists deem it safe to do so
•If able to become pregnant (i.e. assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).
•Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
•Are proficient in speaking and reading English
•Agree to have all clinic visit sessions recorded to audio and video

Exclusion Criteria

•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
•Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at V0 (see Appendix A)
•Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation
•Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
•Have a history of, or a current primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder
•Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 8.0: Concomitant Medications.
•Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.

Arms & Interventions

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.

Intervention: MDMA

Outcomes

Primary Outcomes

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

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).

Secondary Outcomes

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 6)(24 weeks)
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 10)(24 weeks)
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)(24 weeks)
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 11)(24 weeks)
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 7)(24 weeks)
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 8)(24 weeks)
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 9)(24 weeks)
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 14)(24 weeks)
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)(24 weeks)
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)(24 weeks)
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)(24 weeks)
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 5)(24 weeks)
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 15)(24 weeks)
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 12)(24 weeks)
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 13)(24 weeks)
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 16)(24 weeks)