Trials / Withdrawn
WithdrawnNCT05344625
Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress
Ketamine-Assisted Psychotherapy Viability in Treating Cancer-Related Emotional Distress
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Northwell Health · Academic / Other
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The present study will investigate if ketamine-assisted psychotherapy during palliative radiation therapy is safe, feasible, and effective at reducing psychological distress.
Detailed description
Patients prescribed palliative radiation therapy with moderate-severe cancer-related anxiety or depression will be prescribed 3 Ketamine Assisted Psychotherapy (KAP) sessions. At the time of enrollment, they will complete surveys to assess depression, anxiety, and existential distress. KAP will be preceded by a preparatory session during which the subjects will virtually meet their the KAP clinical team, discuss important stressors or concerns, and prepare for KAP. Each KAP session will last approximately 3 hours during which patients will receive an individualized dose of Ketalar intramuscularly, and after the ketamine experience subsides, the patient will discuss the experience with a psychotherapist trained in KAP. A virtual integration session will occur the day after each KAP session as it provides patients with an opportunity to work collaboratively with their assigned therapist in a manner that can help translate any insights from their preparation and KAP sessions into actionable goals. Depression, anxiety, and existential distress will be measured throughout the trial to assess the impact from KAP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ketamine 100 MG/ML | Ketamine Assisted Psychotherapy |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2024-03-15
- Completion
- 2024-03-15
- First posted
- 2022-04-25
- Last updated
- 2024-01-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05344625. Inclusion in this directory is not an endorsement.