Tobacco Use Disorder Research

What small trials of psilocybin combined with quit-smoking therapy have found, how they compare with the nicotine patch, and why the evidence is still early and not an approved treatment.

Content last updated October 22, 2026. This page has not been medically reviewed.

Where this research stands

Researchers have asked whether psilocybin, the active compound in some mushrooms, given inside a structured quit-smoking program, can help people stop smoking. This page describes that research only. It is not a treatment guide, and it does not recommend that anyone use psilocybin to quit. We did not verify a regulator-approved use of psilocybin for tobacco use disorder this session, so treat it as an experimental research question.

Evidence labels used here: approved medicine, promising but limited, mixed, insufficient evidence. For psilocybin and smoking, the overall label is promising but limited: the findings come from a handful of small studies at one research group, and only the newest used a comparison group.

The studies, in order

Study	Design and people	Main result	Limits
2014 pilot	Open-label (everyone knew what they got), 15 smokers in good mental health, psilocybin plus a 15-week quit program [1]	12 of 15 (80%) were not smoking at 6 months, confirmed by tests [1]	No comparison group; authors say it cannot show efficacy [1]
2017 follow-up of the same 15 people	Same participants checked again later [2]	10 of 15 (67%) abstinent at 12 months; 9 of 15 (60%) at long-term follow-up, about 30 months on average, with 12 of 15 returning [2]	Still no comparison group
2026 pilot randomized trial	82 smokers in good mental health; psilocybin plus behavioral therapy versus the nicotine patch plus the same therapy [3]	At 6 months, 40.5% of the psilocybin group and 10.0% of the patch group were verified as continuously abstinent [3]	Participants and investigators knew who got what [3]

The 2014 and 2017 reports describe one study, not two. Counting them twice would overstate the amount of evidence.

The 2026 randomized trial in more detail

Both groups also received a 13-week manualized cognitive behavioral therapy (CBT) program. The patch group used a patch approved by the US Food and Drug Administration. [3] A second measure, abstinence over the previous 7 days, was 52.4% with psilocybin and 25.0% with the patch. [3] Of the 82 people, 68 completed the 6-month check, so results rely on an intention-to-treat analysis that counts everyone randomized. [3] No serious adverse events were attributed to either treatment. [3]

How much weight does this deserve? It is a pilot, meaning a first, small trial. Because the groups could not be hidden from each other, hopes about psilocybin may have shaped results, a problem explained in how to read a psychedelic clinical trial. The authors disclose grants and personal fees from several psychedelic-related companies. [3] The trial is registered as NCT01943994. [3]

What systematic reviews add

A 2025 systematic review of psilocybin for substance use disorders found 16 published studies, five on tobacco use disorder, and only one double-blind randomized trial across all substance types. [4] It concluded that preliminary evidence supports efficacy and safety for alcohol and tobacco use disorders, particularly with psychotherapy, but that larger trials are needed. [4] It also noted that mystical-type experiences predicted long-term outcomes, which is an association, not proof that the experience causes quitting. [4] Another 2025 review said the tobacco evidence behind moving toward larger trials came from an open-label phase 2 study. [5] The first review also counted 26 ongoing registered trials, so this picture may change. [4]

Who was studied, and who was not

The trials above enrolled smokers described as psychiatrically healthy. [3][1] That means we do not know how psilocybin behaves for smokers with depression, bipolar disorder, psychosis risk or heart disease. See screening and eligibility and adverse effects and contraindications.

If you want to quit smoking

Approved options exist, including the nicotine patch used as the comparison in the 2026 trial. [3] A clinician or pharmacist can explain them. This page cannot tell you what is right for you. For help with substances in general, see substance use support and urgent help. Psilocybin remains a controlled substance in many places; see legal status by country, which is not legal advice.

Frequently asked questions

Is psilocybin an approved treatment for quitting smoking?

We did not verify an approval for this use on a regulator page this session. The trials are research studies. The authors of the 2014 pilot wrote that its open-label design does not allow definitive conclusions about efficacy. [1]

Did psilocybin beat the nicotine patch?

In one pilot randomized trial of 82 smokers, more people in the psilocybin group were verified abstinent at 6 months (40.5% versus 10.0%). [3] The trial was unblinded and small, so a larger, better-concealed trial is still needed.

Were there safety problems in these trials?

The 2026 trial reported no serious adverse events attributed to either treatment. [3] Participants were screened, healthy adults, so these results do not cover everyone.

How long were people followed?

The 2026 trial measured abstinence 6 months after the target quit date, with 68 of 82 people completing that check. [3] The 2014 pilot group was checked again at 12 months and later, up to 57 months after the first session. [2] Longer follow-up in a comparison-controlled trial has not been reported in the sources we read.

Does a strong psychedelic experience predict who quits?

A systematic review reported that mystical experiences predicted long-term outcomes. [4] That is a link seen in data, not evidence that creating such an experience works.

References

Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.