Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction
In an open-label 15-week pilot with 15 nicotine-dependent smokers, moderate and high doses of the 5-HT2A agonist psilocybin administered alongside structured cessation support yielded an 80% biochemically-confirmed seven-day point-prevalence abstinence rate at six months, substantially higher than typical rates (<35%). While the uncontrolled design prevents definitive efficacy claims, the study suggests psilocybin may be a promising adjunct to smoking cessation treatment and provides a framework for future controlled research.
Authors
- Albert Garcia-Romeu
Published
Abstract
Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow-up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20 mg/70 kg) and high (30 mg/70 kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction.
Research Summary of 'Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction'
Introduction
Earlier research from the 1950s–1970s suggested therapeutic potential for 5-HT2AR agonist hallucinogens in treating substance use disorders, but many of those studies lacked modern methodological rigour and the field was largely abandoned amid controversy and regulatory restrictions. More recent experimental work with psilocybin in healthy volunteers and in patients with advanced cancer has reported mystical-type experiences and enduring positive behaviour change well beyond the acute drug effect, suggesting a possible mechanism relevant to addiction treatment given associations between increased spirituality and recovery outcomes. Johnson and colleagues therefore conducted an open-label pilot study to assess the safety and feasibility of psilocybin as an adjunct to a structured smoking cessation intervention. The study aimed to establish whether a psilocybin-facilitated protocol could be delivered safely, and whether preliminary cessation rates would justify proceeding to a randomized controlled trial; no control condition was included in this first-step evaluation.
Methods
This was a 15-week, open-label pilot study in which psilocybin was administered within a manualised smoking cessation programme. Psilocybin sessions occurred in weeks 5, 7, and 13. The institutional review board approved the protocol and participants gave informed consent. Fifteen nicotine-dependent, psychiatrically healthy adults (10 male; predominantly White) were enrolled after telephone and in-person screening from a pool of 323 telephone-screened individuals. Inclusion criteria included smoking at least 10 cigarettes per day, multiple prior quit attempts, medical fitness on examination and laboratory tests, and continued desire to quit. Exclusion criteria included personal or family history of psychotic or bipolar disorder and drug dependence (other than nicotine) within the prior 5 years. Ten participants reported minimal prior hallucinogen use and five were hallucinogen-naïve; participants received no monetary compensation. The psychological intervention combined cognitive behavioural therapy (CBT) for smoking cessation with preparatory and integration work for the psilocybin sessions. Four weekly preparatory meetings preceded a Target Quit Date (TQD) set to coincide with the first psilocybin session (week 5). Sessions included a brief body-scan meditation, development of a brief motivational statement, exposure to a scented oil as a cue-management strategy, and guided imagery. Psilocybin dosing was 20 mg/70 kg for the first (moderate) session, with default higher doses (30 mg/70 kg) for the second and third sessions; participants could choose to repeat the moderate dose. Staff support included at least two team members per participant (one doctoral-level psychologist), daily phone calls for 2 weeks after TQD, and 19 in-person meetings across the programme. Participants were instructed to avoid other smoking cessation treatments during the study. Safety monitoring during sessions included periodic blood pressure and heart rate checks, continuous staff presence, a physician on call, and availability of rescue medications. Participants lay down, wore eye masks, and listened to music while staff provided non-directive interpersonal support. Measures collected throughout intake, treatment and at 6-month follow-up included breath carbon monoxide (CO), urinary cotinine, Timeline Followback (TLFB) for cigarettes per day, Fagerström Test for Cigarette Dependence, Questionnaire on Smoking Urges (QSU), Smoking Abstinence Self-Efficacy (SASE), Wisconsin Smoking Withdrawal Scale (WSWS), Mysticism Scale, States of Consciousness Questionnaire (SOCQ), Persisting Effects Questionnaire, Visual Effects Questionnaire, and a post-session headache interview (administered to the final 10 participants after an interim finding of psilocybin-associated headache in other work). Biological verification used breath CO and urine cotinine thresholds (CO ⩽6 ppm; cotinine <200 ng/mL). Analysis compared intake to 6-month follow-up: paired two-tailed t-tests assessed changes in smoking (TLFB), CO and cotinine; repeated measures ANOVA tested changes across time for QSU, SASE and WSWS; Mysticism scores were compared with paired t-tests. Persisting Effects data were summarised descriptively.
Results
Fifteen participants completed the study; twelve completed all three psilocybin sessions and three completed two sessions but remained in follow-up. A total of 42 psilocybin sessions were conducted (16 moderate, 26 high dose). No clinically significant adverse events requiring physician intervention or pharmacologic rescue occurred. Acute cardiovascular responses were consistent with prior controlled psilocybin research: mean peak systolic blood pressure was 153 mmHg (SD 11; range 134–173) versus baseline 125 mmHg (SD 10; range 105–153); mean peak diastolic blood pressure was 87 mmHg (SD 11; range 72–105) versus baseline 71 mmHg (SD 8; range 55–89); mean peak heart rate was 87 beats/min (SD 11; range 66–120) versus baseline 68 beats/min (SD 9; range 51–89). On the SOCQ, one participant (7%) reported extreme fearful/dysphoric ratings and five others (33%) reported strong fear-related experiences at some point; these episodes resolved within the sessions with staff support. Visual Effects Questionnaire scores showed no increase in clinically significant visual disturbances at 6 months. Of the 10 participants assessed for headache, eight reported at least one post-session headache; mean duration was reported as 5.8 hours (SD 2.4; range 2.0–9.5) and mean severity was mild (mean 2.6 on a 1–6 scale). Five participants used over-the-counter analgesics after sessions. Smoking outcomes were promising: 12 of 15 participants (80%) demonstrated seven-day point prevalence abstinence at 6-month follow-up as assessed by TLFB and verified by CO and cotinine. Eleven of these 12 reported quitting on the TQD and were biologically verified as abstinent throughout the subsequent 10 weeks of active treatment; one of the 12 was unable to provide some samples due to unexpected travel but was biologically verified at attended visits. Three of the abstainers reported brief, self-corrected lapses (1, 4 and 48 cigarettes) in the period between end of treatment and 6-month follow-up. One participant relapsed after 13 weeks of abstinence, smoked an average of 5 cigarettes/day for 14 weeks (down from 19/day at intake), then returned to verified abstinence before 6 months; that person also used nicotine replacement during the relapse. Statistical analyses showed large reductions in self-reported smoking: TLFB comparisons from intake to 6-month follow-up for the entire sample yielded t14 = 11.1, p < .001. Biomarker reductions were statistically significant for breath CO (t14 = 3.8, p < .01) and urine cotinine (t14 = 2.3, p = .04) across the whole sample. Three participants who were smoking at 6 months reported reduced cigarettes/day after TQD (mean 20 before TQD to mean 14 after; t2 = 5.3, p = .03), although their CO and cotinine did not show significant changes from intake to 6 months. Measures of smoking-related psychological processes changed in directions consistent with cessation: repeated measures ANOVA found significant effects across time for SASE confidence (F2,34 = 24.9, p < .001), SASE temptation (F3,43 = 18.5, p < .001), QSU craving (F3,39 = 12.7, p < .001), and WSWS withdrawal (F4,46 = 4.0, p = .009). Linear contrasts indicated increased confidence to abstain and decreased craving and temptation across the assessment period; withdrawal symptoms peaked at 1 week post-TQD and declined significantly through 6 months. Persisting subjective effects were substantial: Lifetime Mysticism scores increased from intake to one week after the final psilocybin session (mean difference +54; t14 = 3.5, p = 0.004). On the Persisting Effects Questionnaire participants reported many more positive than negative persisting changes (mean positive subscale score 55.8% of maximum; mean negative subscale score 5.3% of maximum). Thirteen participants (87%) rated at least one psilocybin session among the 10 most meaningful experiences of their lives; 11 (73%) rated at least one session among the five most spiritually significant. When asked at three weeks post-TQD how psilocybin helped, the most commonly endorsed mechanisms were a shift in future orientation so long-term benefits outweighed immediate desires (endorsed by 73%), increased belief in ability to quit (73%), and changed life priorities making smoking less important (68%). One participant (7%) indicated psilocybin had not helped.
Discussion
Johnson and colleagues interpret these findings as preliminary evidence that psilocybin can be administered safely within a structured smoking cessation programme and that the approach is feasible. Acute effects—transient increases in blood pressure and heart rate, short-lived dysphoric subjective reactions in some sessions, and post-session headaches—were manageable with non-pharmacological support and brief pharmacologic resources on call, and no serious adverse events occurred. The authors contrast the temporally confined adverse effects of psilocybin with the daily adverse-effect profiles of some approved cessation medications. Regarding efficacy, the investigators note that 80% abstinence at 6 months substantially exceeds typical 6-month abstinence rates reported for standard pharmacotherapies and behavioural programmes; they caution, however, that the open-label design, small sample size and high level of staff contact preclude causal conclusions about psilocybin per se. The study sample was relatively homogeneous (predominantly White, well educated) and this may limit generalisability. Dose-related conclusions could not be drawn: all participants who achieved abstinence did so after the first, moderate (20 mg/70 kg) session, while those who did not quit were not helped by subsequent higher-dose sessions. The authors discuss concerns about using a psychoactive substance to treat another substance dependence and argue that 5-HT2AR agonists lack features of compulsive drug-seeking and are not reliably self-administered in animal models; the observation that some participants declined additional sessions is offered as further evidence against a strong psilocybin-seeking tendency in this context. Mechanistically, participant reports and questionnaire changes suggest psychological processes such as expanded temporal perspective, greater self-efficacy, and altered life priorities may contribute to smoking cessation, and the authors recommend qualitative investigations and neuroimaging studies to probe psychological and biological mechanisms. Finally, the investigators conclude that the results justify further research, specifically a randomised controlled trial to determine efficacy and mechanisms, given the large global burden of tobacco-related mortality and the modest success of existing cessation treatments. They acknowledge key limitations of the present pilot—small N, open-label design, unrepresentative sample and inability to disentangle the contributions of intensive behavioural support versus psilocybin—and frame the study as a first step towards more definitive trials.
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METHODS
This study utilized a 15-week course of smoking cessation treatment, with psilocybin administration occurring in weeks 5, 7, and 13. This study was approved by the Johns Hopkins University School of Medicine Institutional Review Board, and participants provided informed consent.
RESULTS
Safety data consisted of acute measures of cardiovascular function during psilocybin sessions, post-session States of Consciousness Questionnaire ratings of acute adverse psychological effects, nextday headache ratings, and Visual Effects Questionnaire data. Smoking cessation outcomes were assessed using Timeline Followback, and biomarker data (breath CO, urine cotinine). Changes in smoking between study intake and 6-month follow-up were examined with 2-tailed paired t-tests. For the Timeline Follow-back data, the t-test compared mean cigarettes per day between the 30 days prior to study intake and the 6 months after TQD. These t-tests were conducted for both the entire study sample (N=15) and the subsample of participants who continued smoking post-TQD (n=3). Repeated measures ANOVA tested for changes in Questionnaire on Smoking Urges, Smoking Abstinence Self-Efficacy, and Wisconsin Smoking Withdrawal Scale scores across 10 time points from intake to 6-month follow-up, and tests for linear contrasts were performed to examine directionality of change over time. Lifetime Mysticism scale scores were compared between intake and 1-week post final psilocybin session using 2-tailed paired t-tests to assess effects of psilocybin administration on scores of mystical experience. Descriptive statistics were calculated to characterize Persisting Effects Questionnaire data regarding positive and negative effects across psilocybin sessions (Table), and mechanisms attributed to psilocybin for smoking cessation (Table).
CONCLUSION
This is the first study to provide preliminary data on the safety and feasibility of psilocybin as an adjunct to smoking cessation treatment. The present results are consistent with previous studies examining 5-HT 2A R agonists in the treatment of drug dependence, suggesting both safety and feasibility, which are discussed in turn. Our results show promise regarding the safety of psilocybin as an adjunct to smoking cessation treatment. Adverse effects associated with psilocybin consisted of modest acute increases in blood pressure, heart rate, dysphoric subjective effects (e.g. anxiety, fear; <7 hours), and headaches (<24 hours). Consistent with previous research administering psilocybin in controlled settings, these effects were readily managed. Such time-limited effects stand in contrast to adverse effects (e.g. nausea, insomnia, abnormal dreams) associated with approved smoking cessation medications requiring daily administration (e.g. bupropion, varenicline;). An advantage of the temporally confined adverse effects of psilocybin is that staff and medical personnel can readily respond with appropriate support and treatment. Results of the present pilot study also support the feasibility of the approach, as 80% of participants were abstinent at 6-month follow-up. Results should be interpreted with caution given the small N and open-label design. Therefore, no definitive conclusions can be drawn about the causal role of psilocybin per se. However, abstinence rates were substantially higher than typical. For example, when paired with 12 brief weekly counseling meetings, pharmacotherapies have shown seven-day point prevalence abstinence rates of 24.9% to 26.3% (bupropion) and 33.5% to 35.2% (varenicline) at approximately 6 months post-TQD. Furthermore, a randomized controlled trial of the Quit for Life CBT program that provided the primary foundation for the manualized intervention used in this study found a 17.2% abstinence rate at 6-month follow-up, although participants in our study received substantially more contact with study staff. Our study provided higher levels of psychosocial support than typical in smoking cessation treatment. However, efficacy rates were higher than observed in studies utilizing similarly extensive CBT-based support. For example, in two trials of extended smoking cessation treatments using a combination of bupropion, nicotine replacement, and CBT ranging from 5 to 12 months in duration, participants showed 45% to 59% seven-day point prevalence abstinence at approximately 6 months. Another issue is the relative racial homogeneity and high education levels of the present study sample, which may have impacted the outcomes. Future studies would benefit from more diverse samples. The study design was unable to discern differential benefits of moderate-dose (20 mg/70 kg) and high-dose (30 mg/70 kg) sessions. All participants who quit smoking (n=12) did so after their initial moderate-dose session, and those who did not quit (n=3) were unable to do so even after their subsequent high-dose sessions. One potential concern is the use of an abused drug (psilocybin) in the treatment of dependence on another drug (tobacco). However, 5-HT 2A R agonists do not engender compulsive drug seeking (National Institute on Drug, consistent with evidence that they are not reliably self-administered in animals. Furthermore, the observation that two participants voluntarily declined a third psilocybin session suggests a lack of psilocybin seeking in the context of the present study. Several plausible mechanisms of hallucinogen-facilitated treatments have been proposed. However, the mechanistic role of psilocybin in smoking cessation remains unclear. Participant responses in the present study suggest that increased temporal horizon, increased self-efficacy, and altered life priorities may be involved. The present results regarding tobacco addiction, combined with previous studies showing efficacy of 5-HT 2A R agonists for treatment of alcoholism and opioid dependence, suggest higher-order psychological and/or biological mechanisms related to addiction are involved. This contrasts with conventional pharmacotherapies for drug dependence, which are typically specific to the pharmacology of a particular drug class. Valuable directions for future research include qualitative study of participants' accounts regarding potential psychological mechanisms, and neuroimaging studies to inform biological mechanisms. This study is the first to examine a 5-HT 2A R agonist in the treatment of tobacco addiction, and illustrates a viable framework for psilocybin-based addiction treatment interventions. An estimated 5 million worldwide deaths per year are caused by tobacco use, and those numbers are projected to rise to over 8 million deaths annually by 2030. Given the global scope of smoking-related mortality, and the modest success rates of approved smoking cessation treatments, the novel approach presented here warrants further investigation with a randomized controlled trial.
Study Details
- Study Typeindividual
- Populationhumans
- Characteristicsopen labelfollow up
- Journal
- Compound
- Author
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