MDMA for Adjustment Disorder (AD) in a Patient with Cancer and a Significant Other (DYAD)

RECRUITMENT FOR STUDY

Sunstone Therapies is currently recruiting participants for a Phase 2 pilot trial that will assess the feasibility, tolerability, and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in dyads (pairs) of patients with cancer and a concerned significant other (CSO).

Introduction and Rationale for Study

The impact of adjustment disorder (AD) and other psychological stress can significantly affect both cancer patients and their loved ones. Studies have demonstrated AD’s association with depression, reduction of quality-of-life, impairment in social relationships and risk of suicide.

Counseling can reduce symptoms of AD for cancer patients, and studies have shown the value of treating both the patient and a family member/significant other as a unit of care given the interpersonal nature of coping and meaning making in the face of cancer

Efficacy of existing approaches, however, remains limited, and there are no medicines that treat AD in both patients and concerned significant others (CSO). 3,4-Methyl enedioxy methamphetamine (MDMA), also known as ecstasy or molly, can reduce defensiveness and fear of emotional injury, enhance communication and introspection, and increase empathy and compassion; thus, the subjective effects of MDMA can create a productive psychological state that enhances the therapeutic process within conjoint psychotherapy.

Purpose and Description

The pilot trial will assess the feasibility, tolerability and preliminary effectiveness of MDMA-assisted conjoint therapy for AD in 10 dyads (pairs) of patients with cancer and a CSO. One of the primary objectives of the study is to assess the effectiveness of the intervention on AD and relationship functioning in patients with cancer and their CSO.

The study involves the following in person activities over a 24 week period:

  • 1 screening visit
  • 2 preparation visits
  • 2 Drug administration
  • 4 Integration sessions
  • 4 follow up visits (may be able to be done remotely)

Important Considerations

  • The study’s therapy and most if not all procedures are at no cost to the participant. Some participant’s insurance may be charged for some assessment procedures. Also, there is no reimbursement for participation, child care, or travel expenses.
  • There is no placebo. Every participant receives a full dose.
  • All visits take place in person at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.
  • Antidepressants will need to be discontinued as well as other possible medications while participating in the study; however, participants MUST NOT discontinue ANY medication until after enrollment and with the study physician’s approval. Study physician will consult with patients’ providers.
  • Study will include psychiatric and medical questionnaires and medical screening including laboratory assessments and electrocardiogram.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must be using a highly effective method of birth control.
  • Risks to participation will be reviewed extensively during the screening and informed consent process.

Potential benefit of participation

MDMA-assisted therapy has the potential to eliminate fear in the face of a cancer diagnosis in both a patient and a loved one, which can lead to improved relationship functioning. Improved relationship functioning includes more open and comfortable communication about cancer and its impact on their life and an increased access to positive coping strategies in the face of a possibly life threatening illness

To inquire about participation in the IUSAD1/Dyad Study, apply below:

Apply For The Study

For more information about the study: https://clinicaltrials.gov/ct2/show/NCT05584826