Story at a glance
- Research into the potential therapeutic uses of psilocybin has grown in recent years.
- Now, new data published in JAMA Psychiatry reveal administration of the hallucinogen paired with psychotherapy was superior to placebo and therapy alone in treating patients with alcohol use disorder (AUD).
- Only three medications are currently approved for AUD in the United States, while fewer than 9 percent of patients receive them.
Results of a new clinical trial show psychotherapy coupled with psilocybin, the active ingredient in “magic mushrooms,” was superior to placebo and psychotherapy alone in treating alcohol use disorder (AUD) among adults.
Study findings were published today in JAMA Psychiatry and come on the heels of new research that shows many psychiatrists disagree with U.S. federal policy classifying the substance as a Schedule I drug. Currently, only three treatments are approved by the Food and Drug Administration (FDA) for AUD: disulfiram, naltrexone and acamprosate.
The trial was the largest yet to investigate therapeutic effects of psilocybin, and future research into the drug could yield new clues on mechanisms of its effects and aid in identifying new treatment targets.
The double-blind, randomized clinical trial was carried out among 93 adults with diagnosed AUD who had at least four heavy drinking days during the 30 days prior to screening. Forty-eight patients received two administrations of high-dose psilocybin over the course of 12 weeks of manualized psychotherapy, while 45 individuals received diphenhydramine (Benadryl) at the same time periods as a placebo. All study participants underwent therapy.
Drugs were administered during two-day medication sessions at weeks four and eight, and outcomes were assessed at 32 weeks following the first dose of each medication. At week four, participants received either 25 mg/70 kg of psilocybin or 50 mg of diphenhydramine. At week eight, doses were increased to 25-40 mg/70 kg of psilocybin or 50-100 mg of the placebo.
Throughout the follow-up period, 9.7 percent of those who received psilocybin reported heavy drinking days compared with 23.6 percent of the placebo group, marking a nearly 14 percent difference.
Hair or fingernail samples tested for ethylglucuronide (EtG) concentration to confirm self-reported abstinence were only available for 53.8 percent of treated participants, authors noted.
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Mean daily alcohol consumption was also lower in the intervention group while no serious adverse events were reported in this cohort. Headaches, anxiety and nausea were common side effects among those who received psilocybin.
All participants had not used any hallucinogen drugs within the past year or reported less than 25 uses throughout their lifetimes. Participants were also not currently undergoing any other treatments for their AUD.
“Although this was, to our knowledge, the first controlled trial of psilocybin for AUD, these findings are consistent with a meta-analysis of trials conducted in the 1960s evaluating LSD as a treatment for AUD,” authors wrote. LSD, or lysergic acid diethylamide, is another hallucinogen.
Despite the limited adverse effects seen in this trial, researchers emphasize these cannot be generalized to all psilocybin use, as the drug was administered in a controlled setting and medications to treat acute psychiatric reactions were on hand.
In addition, “diphenhydramine was ineffective in maintaining the blind after drug administration, so biased expectancies could have influenced results,” marking a limitation of the study.
Results might also not be generalizable to individuals with more severe AUD, and researchers were unable to study outcomes based on subgroups. Future studies are needed to address these questions and investigate whether results are sustained beyond 32 weeks.
AUD remains underdiagnosed and undertreated in the United States, authors wrote in an accompanying editorial, as less than 9 percent of adults with AUD currently take an FDA-approved medication for the condition. Alcohol-related deaths are also the third most common preventable deaths in the United States.
Another important question raised by the trial “is the extent to which a hallucinogenic experience is required for psychedelic drugs to have a therapeutic effect,” while the optimal combination of medication and psychotherapy to treat AUD remains unknown.
The intensive psychotherapy included in the trial is also resource intensive and may thus limit the use of hallucinogens in clinical practice.
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