The experiment was carried out with the participation of 93 alcoholics, both male and female, and was directed by researchers from the NYU Grossman School of Medicine.
They were given a placebo antihistamine or were given a random assignment to receive either two doses of psilocybin or the antihistamine. Neither the researchers nor the people who took part in the trial were aware of the drug each participant was given.
Those who were administered psilocybin at the beginning of their therapy reduced the amount of heavy drinking they did by 83% in the space of eight months, in comparison to the amount of drinking they did before the trial began. In the meantime, individuals who had been given antihistamine were able to cut their alcohol consumption by 51%.
The study found that eight months following their initial dosage, over half (48%) of individuals who took psilocybin stopped drinking entirely, in comparison to just 24% of those in the placebo group. This was one of the other significant results of the research.
“Our findings strongly suggest that psilocybin therapy is a promising means of treating alcohol use disorder, a complex disease that has proven notoriously difficult to manage,” says study senior author and psychiatrist Michael Bogenschutz, MD, director of the NYU Langone Center for Psychedelic Medicine.
According to the Centers for Illness Control and Prevention of the United States, Americans die from excessive alcohol consumption around 95,000 times each year. These deaths are frequently the result of binge drinking or liver disease. According to Bogenschutz, who is also a professor in the Department of Psychiatry at NYU Langone Health, it is also connected to massive economic and workplace losses, injury accidents, and poor learning, memory, and mental health. All of these issues are caused by stress.
Psychological therapy, detoxification programs under supervision, and some pharmacological regimens that decrease urges are some of the current approaches that are used to avoid excessive use of alcohol and reliance on the substance.
Psilocybin medication was previously known to be an effective technique of reducing anxiety and sadness in persons with the most severe kinds of cancer, according to the researchers who conducted the study. This was established by findings from prior research. In addition, early studies conducted by Bogenschutz and others revealed that psilocybin could be useful as a possible treatment for alcohol use disorder as well as other types of addictions.
According to the authors of the study, the newly published research is the first placebo-controlled experiment to investigate the use of psilocybin as a therapy for excessive alcohol consumption. The study was published on August 24 in the journal JAMA Psychiatry.
For the purpose of this experiment, the research team solicited the participation of male and female patients who, according to the criteria used to diagnose alcohol dependency, had drunk an average of seven alcoholic beverages on days when they partake in drinking. Forty-eight individuals were given at least one dosage and up to three doses of psilocybin, whereas forty-five patients were given a placebo consisting of an antihistamine.
Everyone participated in anywhere from six to twelve sessions of psychotherapy. Both before and after the pharmacological treatments, these took happened. After that, the participants were asked to indicate the proportion of days throughout weeks 5 to 36 of the study in which they engaged in excessive drinking.
In addition, they gave samples taken from their hair and fingernails to prove that they had not been drinking. After that, a third psilocybin session was made available to each and every participant so that even those who had been given a placebo in the past would have the opportunity to experience the effects of the psychedelic substance.
“As research into psychedelic treatment grows, we find more possible applications for mental health conditions,” says Bogenschutz. “Beyond alcohol use disorder, this approach may prove useful in treating other addictions such as cigarette smoking and abuse of cocaine and opioids.”
According to Bogenschutz, the next step for the study team will be to perform a bigger experiment across many centers as part of an FDA IND that will be financed by B.More Inc. Before the medication is suitable for widespread clinical application, he warns that further research has to be conducted to record the effects of psilocybin and to explain the right dosage. He makes the observation that researchers have begun such tests.
The mind-altering effects of psilocybin are comparable to those produced by LSD and mescaline. Psilocybin is a naturally occurring substance that is obtained from fungus. The majority of people who take part in this research report having dramatic shifts in their perceptions, feelings, and sense of who they are. These changes frequently include having experiences that are believed to be of high personal and spiritual value.
Researchers warn that because the drug can cause incapacitating and sometimes overwhelming psychological effects, it should only be used in carefully controlled settings and in conjunction with psychological evaluation and preparation. This is due to the fact that the drug raises blood pressure and heart rate as well as the fact that it can cause these effects.
Design, Setting, and Participants
Participants in this randomized clinical trial were offered 12 weeks of manualized psychotherapy and were randomly assigned to receive psilocybin or diphenhydramine during two day-long medication sessions at weeks 4 and 8. The trial was conducted with participants blinded to the identity of the other participant. After the initial dose of the study medicine, the outcomes were evaluated over the course of a double-blind period that lasted for 32 weeks. The research was carried out in the United States at two different academic institutions. Participants came from the local community and were solicited for participation between March 12, 2014 and March 19, 2020. Participants had to be adults aged 25 to 65 years old, have a DSM-IV diagnosis of alcohol dependence, and have at least four days of heavy drinking in the 30 days preceding to screening in order to be considered. The use of hallucinogens, significant mental and substance use problems, physical illnesses that were incompatible with the research drugs, the use of exclusionary medications, and ongoing treatment for AUD were all considered to be ineligible for participation.
The drugs used in the study were psilocybin at a dose of 25 mg/70 kg compared to diphenhydramine at a dose of 50 mg (the first session), then psilocybin at a dose of 25-40 mg/70 kg compared to diphenhydramine at a dose of 50-100 mg (second session). The psychotherapy that was provided includes cognitive behavioral therapy as well as motivational improvement treatment.
Main Outcomes and Measures
The primary outcome was the proportion of heavy drinking days, which was determined using a timeline followback interview and compared across groups using multivariate repeated-measures analysis of variance over the course of 32 weeks following the initial dose of study drug.
A total of 95 participants (mean [SD] age, 46  years; 42 [44.2%] female) were randomized (49 to psilocybin and 46 to diphenhydramine). One participant (1.1%) was American Indian/Alaska Native, 5 (5.3%) were Black, 16 (16.8%) were Hispanic, and 75 (78.9%) were non-Hispanic White. Of the 95 randomized participants, 93 received at least 1 dose of study medication and were included in the primary outcome analysis. Percentage of heavy drinking days during the 32-week double-blind period was 9.7% for the psilocybin group and 23.6% for the diphenhydramine group, a mean difference of 13.9%; (95% CI, 3.0–24.7; F1,86 = 6.43; P = .01). Mean daily alcohol consumption (number of standard drinks per day) was also lower in the psilocybin group. There were no serious adverse events among participants who received psilocybin.
Conclusions and Relevance
When psilocybin was given in conjunction with psychotherapy, significant reductions in the proportion of heavy drinking days were obtained. These reductions were much greater than those produced by active placebo and psychotherapy alone. These findings lend credence to the need for more research into the use of psilocybin in the treatment of AUD.
ClinicalTrials.gov Identifier: NCT02061293