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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must have solid or hematological malignancy that does not involve the brain.

Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months

Age ≥ 18 years.

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.

Disqualifiers

History of bipolar disorder, psychosis (including a history of schizophrenia).

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.

Postmenopausal (no menses in greater than or equal to 12 consecutive months).

History of hysterectomy or bilateral salpingo-oophorectomy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin

    Drug

    Participants will recive treatment by mouth on an outpatient basis.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment with PsilocybinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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