Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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. Eighty additional
      participants will be enrolled and randomized to either psilocybin (n=40), or nicotine patch
      (n=40) 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, 50 of these participants (25
      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.
    


Intervention name(s): Psilocybin-assisted treatment; Nicotine Replacement Therapy (NRT)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be administered 30 mg/70 kg psilocybin. Preliminary evidence from our ongoing psilocybin dose-effects study suggests that this dose is associated with mystical-type experiences.
Other intervention name(s): O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine; Transdermal Nicotine Patch; Nicoderm CQ
Intervention MeSH terms: Psilocybin; N,N-Dimethyltryptamine; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psilocybin; Smoking cessation