MDMA-assisted Therapy for Adjustment Disorder in Cancer Patients

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunstone Medical

Must not be taking: Psychiatric medications

Disqualifiers: Psychotic disorder, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether therapy with MDMA, a psychoactive drug, can help cancer patients and their close companions manage adjustment disorder, a stress-related condition. Participants will receive MDMA twice, along with several therapy sessions over an 8-week period. The trial aims to assess the feasibility, tolerability, and effectiveness of this approach. Individuals with cancer who experience stress or mood changes due to their diagnosis may be suitable candidates for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to refrain from certain medications before the experimental sessions, but it does not specify which ones. You may need to discuss your current medications with the study team to see if any adjustments are necessary.

Is there any evidence suggesting that MDMA-assisted therapy is likely to be safe for humans?

Research has shown that MDMA-assisted therapy is usually safe for patients. In a small study involving individuals with alcohol use disorder, participants reported no serious side effects. This suggests MDMA could be safe for therapy. However, these findings are based on early research. Safety remains a priority, and further studies are underway to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for adjustment disorder?

MDMA-assisted therapy is unique because it combines the psychoactive effects of MDMA with structured therapy sessions, offering a novel approach to treating adjustment disorder in cancer patients. Unlike traditional treatments that often focus on medications like antidepressants or therapy alone, MDMA works by enhancing emotional engagement and openness during therapy, potentially leading to deeper psychological healing. Researchers are excited about this treatment because it may provide quicker and more profound relief from distress associated with cancer, helping patients process their emotions more effectively and improving their overall quality of life.

What evidence suggests that MDMA-assisted therapy might be an effective treatment for adjustment disorder in cancer patients?

Research has shown that MDMA therapy effectively reduces anxiety in individuals with serious illnesses and PTSD, a mental health condition triggered by a frightening event. One study found that 71.2% of participants receiving MDMA-assisted therapy for PTSD no longer exhibited signs of the disorder by the end of treatment. This trial will investigate whether MDMA-assisted therapy can also benefit cancer patients with adjustment disorder, a stress-related condition. Participants will receive MDMA combined with talk therapy to help them better understand and manage their emotions and experiences. Early results appear promising, but further research is necessary to confirm its effectiveness specifically for adjustment disorder. ^{1 2 3 5 6}

Who Is on the Research Team?

Manish Agrawal, MD

Principal Investigator

Sunstone Medical, PC

Are You a Good Fit for This Trial?

This trial is for adult cancer patients with adjustment disorder and their significant others, who speak English, can swallow pills, and agree to study procedures including audio/video recording. Excluded are those with certain heart conditions, severe medical issues, recent heavy MDMA use, or uncontrolled hypertension.

Inclusion Criteria

I am using effective birth control and have a negative pregnancy test.

I have a spouse or close family member who is key to my well-being.

My high blood pressure is well-managed with medication.

Exclusion Criteria

I have had irregular heartbeats but not due to heart disease.

I have had low sodium levels or very high body temperature in the past.

You have had serious thoughts of hurting yourself or had a plan to do so in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week treatment period including two doses of MDMA, two Preparatory Sessions, and four Integrative Sessions of non-drug therapy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MDMA

Trial Overview The trial tests the effects of MDMA-assisted therapy on pairs consisting of a cancer patient and a close person. Over 8 weeks they'll have two sessions with MDMA and six non-drug therapy sessions to see how well it works for emotional distress from cancer.

How Is the Trial Designed?

Group I: MDMA-Assisted Therapy Experimental Treatment 1 Intervention

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.

MDMA is already approved in United States for the following indications:

Approved in United States as MDMA for:

• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

Sunstone Medical

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

MDMA, commonly known as ecstasy, is often mistakenly believed to be a safe drug, but its use has led to significant health risks, including serious cardiovascular effects and long-term neuropsychiatric issues.

The review highlights the increasing prevalence of ecstasy use among teenagers and young adults, emphasizing the need for awareness of its potential for toxicity and the importance of proper emergency care for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ecstasy toxicity]. Reingardiene, D.[2018]

MDMA, used by over 16 million Americans, produces desirable effects like increased energy, elevated mood, and social bonding, but it also carries significant risks including liver damage, serotonin syndrome, and even death.

The drug's effects are influenced by its unique pharmacological profile and the rave environment, which can enhance both its positive and negative effects, highlighting the need for education and harm prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How MDMA's pharmacology and pharmacokinetics drive desired effects and harms. Michael White, C.[2019]

In a preliminary study of MDMA-assisted psychotherapy for alcohol use disorder, the first four participants tolerated the treatment well, with no serious adverse events or unexpected physiological responses observed during the 8-week course.

The results suggest that MDMA-assisted therapy is safe and tolerable, prompting plans to expand the research into a randomized placebo-controlled study to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants. Sessa, B., Sakal, C., O'Brien, S., et al.[2021]

In a study involving 39 healthy adults, MDMA did not reduce physiological or subjective stress responses during a public speaking task, contrary to the hypothesis that it would dampen stress reactions.

While MDMA is known for its potential benefits in treating PTSD, this research indicates that a single dose does not moderate acute stress responses, suggesting that its therapeutic effects may depend on different conditions or contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA does not alter responses to the Trier Social Stress Test in humans. Bershad, AK., Miller, MA., de Wit, H.[2018]

In a phase 2 trial involving 26 veterans and first responders with chronic PTSD, MDMA doses of 75 mg and 125 mg combined with psychotherapy significantly reduced PTSD symptoms compared to a 30 mg dose, with large effect sizes indicating strong efficacy.

The treatment was well tolerated, with only 5% of reported adverse events being serious, suggesting that MDMA-assisted psychotherapy is a safe option for this population when administered in a controlled setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Mithoefer, MC., Mithoefer, AT., Feduccia, AA., et al.[2019]

MDMA, once used as a therapeutic aid before being classified as a Schedule I drug in 1985, has shown promise in treating posttraumatic stress disorder (PTSD) when used in psychotherapy, despite limited research due to its scheduling.

The review highlights the brain regions affected by both PTSD and MDMA, such as the amygdala and hippocampus, suggesting that MDMA may work through specific neurochemical mechanisms to enhance therapeutic outcomes in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychopharmacology of ±3,4 Methylenedioxymethamphetamine and its Role in the Treatment of Posttraumatic Stress Disorder. Amoroso, T.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05584826

MDMA-assisted Therapy for Adjustment Disorder (AD) in ... The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110200/

Effect of MDMA-assisted therapy on mood and anxiety ... This study will examine the effect of MDMA-assisted therapy on symptoms of anxiety and depression in advanced-stage cancer.

3. withpower.com withpower.com/trial/phase-2-adjustment-disorders-9-2022-ce5e5

MDMA-assisted Therapy for Adjustment Disorder in Cancer ... Research shows that MDMA-assisted therapy has been effective in reducing anxiety in people with life-threatening illnesses and PTSD, suggesting it might help ...

4. ucsf.edu ucsf.edu/news/2023/09/426116/mdmas-latest-trial-results-offer-hope-for-patients-ptsd

MDMA's Latest Trial Results Offer Hope for Patients with ... By the end of the 18-week trial period, 71.2% of the people in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD, ...

5. sunstonetherapies.com sunstonetherapies.com/science/clinical-trials/mdma-for-adjustment-disorder-in-cancer-patients-with-significant-other-2023/

MDMA for Adjustment Disorder in Cancer Patient Dyad The pilot trial will assess the feasibility, tolerability and preliminary effectiveness of MDMA-assisted conjoint therapy for AD in 10 dyads (pairs) of ...

6. maps.org maps.org/1995/08/22/a-dose-response-human-pilot-study-safety-and-efficacy-of-mdma-in-modification-of-physical-pain-and-psychological-distress-in-end-stage-cancer-patients/

Safety and Efficacy of MDMA in Modification of Physical ... This is a dose/response pilot study investigating the safety, efficacy and mechanisms of action of MDMA and guided imagery in modifying ...