RecruitingDepressionAnxietyCancer
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 1. Subjects must have solid or hematological malignancy that does not involve the brain.
- ✓ 2. Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months
- ✓ 3. Age ≥ 18 years.
- ✓ 4. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder, Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnoses are determined by. an MD Anderson licensed healthcare provider with graduate-level profession training and clinical experience in psychotherapy, licensed to practice independently.
- ✓ 5. Have an ECOG performance status of 0, 1, or 2.
- ✓ 6. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).
- ✓ 7. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.
- ✓ 8. Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance.
You may not qualify if…
- ✕ 1. Clinically significant suicidality or high risk of completed suicide defined as:
- ✕ i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self injurious behavior
- ✕ 2. History of bipolar disorder, psychosis (including a history of schizophrenia).
- ✕ 3. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.
- ✕ 4. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- ✕ 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).
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT06801041 · last updated 2026-06-24