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Psilocybin-assisted Psychotherapy for Depression and Anxiety in Cancer Survivors

This study, called TRIPS, is looking at how safe and effective psilocybin-assisted psychotherapy is for cancer survivors who are experiencing depression and/or anxiety. You would receive psilocybin by mouth as an outpatient. The study aims to enroll 20 participants who are at least 18 years old and have a history of cancer that does not involve the brain, with no evidence of disease for the past 6 months. To be considered a success, the study will look at how many eligible patients join, how many complete the treatment, and how many complete follow-up assessments. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive psilocybin treatment by mouth on an outpatient basis. Assessments will be completed at 2- and 6-month follow-ups.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events (side effects) will be measured throughout the study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06801041

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~20 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Psilocybin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Depression
Anxiety
Cancer

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NCT06801041

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Moran Amit, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Moran Amit, MD, PHD
[email protected]
(713) 794-5304
Email the study team

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Eligibility criteria

Exclusion

Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 5. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional. 6. Documentation of current malignancy that is being treated with palliative intent. 7. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study. 8. Patients with brain metastases. 9. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) Blood Pressure \>blood pressure \>180/120mmHG, HR \>110 bpm . Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and "white coat hypertension." 10. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0