Provider FAQs
Psychedelics Research Study with DMT in Major Depression
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- What is the purpose of this study?
This research study is investigating the effects of DMT, a psychoactive compound found in ayahuasca, on symptoms of major depressive disorder (MDD) in adults whose depression has not adequately improved with standard antidepressant treatment.
- Who can participate?
Adults aged 21 to 65 years who meet one of the following criteria:
- Major Depressive Disorder (MDD): Currently experiencing a moderate to severe depressive episode and have had an unsatisfactory response to at least one antidepressant trial or are unable to tolerate antidepressants.
- Healthy adults: Individuals without a psychiatric diagnosis who meet health and safety requirements (e.g., BMI 18–35 kg/m², negative drug screen, English speaking).
- What are the key inclusion criteria for participants with depression?
- Diagnosis of Major Depressive Disorder (single or recurrent episode)
- Current moderate to severe depressive episode
- Inadequate response or intolerance to at least one antidepressant
- Engaged in clinical care for depression (or willing to initiate care for study participation)
- Consent to allow communication between the research team and their primary mental health provider
- What are the key inclusion criteria for healthy volunteers?
- Ages 21–65
- BMI 18–35 kg/m²
- English speaking
- Willing to refrain from drug/alcohol use before and after test sessions
- Negative urine drug screen before each test session
- Non-smoker during sessions
- Women of childbearing potential must use effective birth control
- Must not drive to or from study visits
- What does participation involve?
Eligible participants will undergo screening, clinical assessments, and controlled DMT administration sessions under medical supervision.
Participants will continue to engage in treatment with their primary mental health provider throughout the study.- Is there compensation for participants?
Yes. Participants will receive up to $750 for their time and participation.
- How long will the study run?
The study is expected to run from March 14, 2025, through August 31, 2030.
- Who is leading the study?
Principal Investigator: Deepak Cyril D’Souza, MBBS, MD, Vikram Sodhi ’92 Professor of Psychiatry, Director, Schizophrenia Neuropharmacology Research Group at Yale (SNRGY), Director, Yale Center for the Science of Cannabis and Cannabinoids, VA Connecticut Healthcare System
Sub-Investigators:
- Jose Cortes-Briones
- Mohini Ranganathan, MBBS
- Prakash Gupta
- How can providers refer a patient or learn more?
Providers can contact the Yale Center for the Science of Cannabis and Cannabinoids or the Schizophrenia Neuropharmacology Research Group (SNRGY) team for additional details on eligibility, referral procedures, and screening.
The Study Team contact name:
Coordinator: Prakash Gupta, MD,
Phone Number: 203-932-5711, ext. 14495,
Email: Prakash.gupta@yale.edu or yalecannabisresearch@yale.edu
- What should providers know about safety and oversight?
All study procedures are conducted under strict medical supervision and IRB-approved protocol (HIC #2000034770). Participants remain under the care of their treating clinicians, and collaboration with providers is encouraged throughout the study period.
THC-Aging Study
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- What is the purpose of this study?
This study examines how aging influences the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis. Findings from this research will help improve understanding of the potential risks and benefits of cannabis use in older adults.
- Who can participate?
Adults aged 21 years and older who have used cannabis and/or THC at least once in the past ten years may be eligible.
- What does participation involve?
Participation takes approximately 12 total hours, including:
- Visit 1 – Screening (about 4 hours): medical and psychological evaluations, urine drug test, and consent process.
- Visit 2 – Test Day (about 8 hours): participants receive two of the following under medical supervision: placebo, low-dose THC, or medium-dose THC.
- Follow-up telephone questionnaires at approximately 24 hours, 1 month, 3 months, and 6 months after the dosing day.
- What are the inclusion/exclusion criteria?
Inclusion Criteria:
- Age 21 years or older
- At least one use of cannabis/THC in the past 10 years
- Negative urine screen for illicit substances at screening and dosing (cannabinoids excluded)
- No serious medical or neurological illness
- No personal or family history of psychosis in a first-degree relative
- Weight ≤ 220 lbs (100 kg)
- High school education or higher
- English speaking
- What are the safety precautions?
• All sessions are conducted under direct medical supervision by trained research staff.
• Participants are screened carefully to ensure safety and exclude individuals at risk for adverse psychiatric or medical effects.
• The study is IRB-approved and monitored under Yale’s research compliance standards.- What is the compensation?
Participants will receive up to $350 total:
- $50 for the screening session
- $300 for the dosing day
- How might this study benefit patients?
While there is no direct clinical benefit to participation, the study will contribute valuable information about how age affects the brain’s response to THC, helping to inform safe cannabis use guidelines for older adults.
- Who is leading this study?
Principal Investigator: Dr. Deepak Cyril D’Souza, MBBS, MD, Vikram Sodhi ’92 Professor of Psychiatry; Director, Yale Center for the Science of Cannabis and Cannabinoids; Director, Schizophrenia Neuropharmacology Research Group at Yale (SNRGY)
Sub-Investigators:
- Ashley Schnakenberg Martin, PhD
- Jose Cortes-Briones
- How can providers refer patients or learn more?
- Phone: 203-937-3830 (Research Coordinator)
- Email: yalecannabisresearch@yale.edu
- Dr. D’Souza’s Office: 203-932-5711 x12594
- Interested individuals may also complete the Prescreening Interest Form (link available upon request).
- What is the study’s oversight and funding source?
This research is sponsored and funded by the National Institute on Drug Abuse (NIDA) and approved under Yale IRB protocol HIC #2000038388.
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