Hundreds of clinics may be using false and misleading statements in online advertising campaigns by offering off-label and unapproved ketamine to treat a variety of mental health and pain conditions, according to researchers.
In the study published in JAMA Network Open, the researchers noted that intravenous ketamine is not approved by the US FDA to treat any mental health condition but is sometimes used off-label for it.
Oral formulations are unapproved drugs that are often advertised to produce a hallucinogenic experience at home.
"These are expensive treatments for which patients generally must pay out of pocket and the evidence base is often not robust for many of the advertised uses," said Michael DiStefano, Assistant Professor in the Department of Clinical Pharmacy at the University of Colorado Anschutz Medical Campus.
"It is important that people considering these treatments are provided with an accurate and balanced statement of the possible risks and benefits," he added.
For the study, the team identified online direct-to-consumer ketamine advertisers with at least one clinic in Maryland and a website by using six national ketamine databases.
They found 17 advertisers operating across 26 locations in Maryland that promoted infusions or ketamine assisted therapy for a wide range of conditions including depression, post-traumatic stress disorder (PTSD), anxiety and chronic pain. The advertising revealed numerous misleading representations regarding treatment and safety.
While the study focused on clinics in Maryland, DiStefano said their compilation of the six directories for ketamine treatment suggests that there are approximately 800 such clinics across the US. He said there are also several companies that will send customers oral ketamine through the mail.
"Psychedelic or hallucinogenic substances are increasingly being considered as mental health treatments. For example, Colorado is at the vanguard of developing policies to govern the use of psilocybin in depression." DiStefano said.
"It is important to be transparent and accurate when explaining the potential risks and benefits of these treatments. While these treatments can provide hope and will be effective for some patients, there are real risks associated with ketamine use, especially over the long-term. There are high financial costs to consider as well."
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