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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of MDMA-assisted therapy for adjustment disorder in cancer patients?

Research shows that MDMA-assisted therapy has been effective in reducing anxiety in people with life-threatening illnesses and PTSD, suggesting it might help cancer patients with adjustment disorders too. ^{1 2 3 4 5}

Is MDMA-assisted therapy safe for humans?

MDMA-assisted therapy has been shown to be well-tolerated in a small study with alcohol use disorder patients, with no serious adverse events reported. However, recreational use of MDMA has been associated with potential long-term neuropsychiatric effects, such as mood and memory issues, and possible damage to brain cells, especially with repeated use. ^{1 6 7 8 9}

How is MDMA-assisted therapy different from other treatments for adjustment disorder in cancer patients?

MDMA-assisted therapy is unique because it uses MDMA, a drug known for its stimulant and psychedelic effects, to potentially reduce negative emotional responses and enhance therapeutic outcomes, which is different from traditional treatments that do not involve this drug. ^{1 9 10 11 12}

Research Team

Manish Agrawal, MD

Principal Investigator

Sunstone Medical, PC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute psychological and neurophysiological effects of MDMA in humans. [2013]

2. England pubmed.ncbi.nlm.nih.gov

MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA. [2022]

4. England 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic use of classic psychedelics to treat cancer-related psychiatric distress. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Ecstasy toxicity]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

How MDMA's pharmacology and pharmacokinetics drive desired effects and harms. [2019]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Long-term neuropsychiatric consequences of "ecstasy" (MDMA): a review. [2013]

10. Spain pubmed.ncbi.nlm.nih.gov

MDMA and serotonin: based on two cases. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

MDMA does not alter responses to the Trier Social Stress Test in humans. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

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