Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
One of the most promising lines of investigation for the therapeutic use of hallucinogens in
the 1960s and 1970s was in the treatment of drug dependence. The investigators propose to
examine psilocybin administration combined with a structured smoking cessation treatment
program in nicotine dependent individuals in order to provide preliminary data on the
efficacy of this combined treatment for smoking cessation. Prior work in the investigators
laboratory has shown that under carefully prepared and supportive conditions, psilocybin
administration can facilitate highly salient experiences with enduring personal meaning and
spiritual significance. It is plausible that embedding such highly meaningful experiences
into a drug dependence cessation attempt may provide an enduring motivation for remaining
abstinent. Cigarette smoking is a good model system for studying drug dependence because
users are less likely to be challenged by the many social and economic impairments that often
accompany dependence on other drugs such as cocaine, heroin, or alcohol. More specifically,
the investigators propose to conduct a randomized controlled comparative efficacy study in
which either psilocybin or transdermal nicotine patch are administered under highly
supportive conditions to individuals who are nicotine-dependent cigarette smokers, who have
had multiple unsuccessful quit attempts, and who continue to desire to quit smoking. Other
than nicotine dependence, participants will be healthy. Fifteen participants have already
completed a preliminary open-label pilot-study with no control condition. One hundred
additional participants will be enrolled and randomized to either psilocybin (n=50), or
nicotine patch (n=50) treatment. Participants will receive a 13-week course of cognitive
behavioral therapy for smoking cessation, with Target Quit Date set for week 5. After several
preparation meetings with study monitors, participants will have either a single day-long
psilocybin session using a high dose (30 mg/70 kg), or a standard 8 to 10-week course of
nicotine patch treatment. Participant smoking status will be assessed repeatedly for 8 weeks
after the Target Quit Date, including biological verification of smoking status through
breath and urine samples. Smoking status will also be assessed at three follow up sessions
approximately 3, 6, and 12 months after the Target Quit Date. Additionally, 60 of these
participants (30 per treatment condition) will undergo MRI scanning before and after Target
Quit Date to assess the brain-based mechanisms associated with these treatments. Individuals
assigned to the nicotine patch study treatment condition will be eligible to undergo an
optional high dose psilocybin session after completing the 6-month follow-up meeting.