The Huntsman Cancer Institute, in partnership with the Huntsman Mental Health Institute, is conducting a clinical trial that combines ketamine infusions with traditional talk therapy to combat existential distress in patients with inoperable cancer.

Existential distress refers to the psychological pain caused by a serious or life-threatening diagnosis, and the host of issues surrounding the meaning of life and the fear of death that comes alongside it.

Ben Lewis, assistant professor of psychiatry at the Huntsman Mental Health Institute, is the co-principal investigator in the study. Lewis said existential distress is not a mental disorder, but it is a condition that causes suffering in patients and their loved ones.

“It’s a reliable phenomenon,” he said. “It’s commonly found in particular with patients with advanced cancer diagnoses. It is a constellation of features that is very difficult to treat meaningfully with standard pharmacologic tools.”

The study is being run through the Ketamine-Assisted Psychotherapy Clinic in Park City. The patients participating were diagnosed with inoperable gastrointestinal cancer.

Lewis said patients have a 90-minute consultation to ensure they are safe to participate in the study. The participants are then paired with a therapist and have three 60-minute ketamine-assisted psychotherapy sessions. Once those sessions are finished, the participants undergo an integration therapy session to examine their experience.

The patients will be tracked three months after the therapy sessions, and the study will take about a year to finish.

During the ketamine-induced sessions, participants wear masks that cover their eyes and listen to music.

“Having music playing is a key part of the experience to support the mind-altering psychedelic effects of ketamine,” said Kevin Byrne, assistant professor of clinical psychiatry at the U and co-principal investigator of the study. “The person wears an eye mask [and] is encouraged to have a mostly internal experience rather than looking around the room or doing a lot of talking.”

The type of psychotherapy used in the study is acceptance and commitment therapy. According to the American Psychological Association, ACT is a form of therapy that helps patients accept difficult thoughts and feelings as part of a meaningful life and helps them develop new thoughts and behaviors when faced with difficult challenges.

All of the participants in the clinical trial know they will be receiving the treatment. Lewis said the next step for KAP would be a randomized controlled study.

“Blinding is the key component of randomized controlled trials, which is the foundational type of trial that medical science is based on, and it helps us differentiate treatments that are truly more helpful than giving somebody a placebo,” Byrne said. “Psychedelic medications or drugs have overt, conscious, mind-altering effects, and so most people can tell whether they got something that changes their mental experience versus a placebo, which makes it hard to blind these studies.”

Lewis said some of the ways researchers have tried to solve this problem is by using active placebos that cause sedating effects like Benadryl or cause a flushing effect like niacin.

“How successful are those methods? It’s not entirely clear,” Lewis said. “So it does present really significant methodological challenges for these trials … [there is] a very active set of debates in the field right now.”

Ketamine has been used off-label to treat depression, and there are between 500 to 750 for-profit ketamine clinics nationwide, all having their own treatment protocols, according to NPR.

Lewis said ketamine infusions as a treatment for depression have an “extensive evidence base,” but ketamine combined with psychotherapy is only starting to emerge.

“We’re living in an interesting time with ketamine currently, and there’s a lot of ketamine happening out in the community and in the country in general,” he said.  ” … That can be a little bit of a mixed bag. So the model of using ketamine with this really robust ketamine-assisted psychotherapy model is, I think, unusual in terms of most practices of ketamine currently.”

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@GiovanniRadtke