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.
Compound Psilocybin
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
01 September 2008
End date
01 December 2023
Chance of happening
100%
Phase
Phase I
Design
Open
Type
Interventional
Generation
First
Participants
95
Sex
All
Age
21- 65
Therapy
Yes
Trial Details
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.NCT Number NCT01943994
Sponsors & Collaborators
Johns Hopkins UniversityJohns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.
Beckley Foundation
The Beckley Foundation is one of the leading voices that has spurred the scientific renaissance of psychedelics research. Led by Amanda Fielding, the NGO funds research and engages with politicians.
Heffter Research Institute
The Heffter Research Institute has been advancing psychedelics (psilocybin) as medicines since 1993.
Papers
Psychedelic therapy for smoking cessation: Qualitative analysis of participant accountsThis long-term, qualitative follow-up study (n=12) dissects the factors that lead to long-term smoking cessation. Vivid insights, rapport with the study team, and good preparation were some factors that led to this effect.
Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction
This is the first study to use psilocybin and cognitive behavioural therapy (CBT) in concert for smoking cessation in an open-label format. Participants received a moderate (20 mg/70kg) and high (30 mg/70kg) of psilocybin with a 15-week smoking cessation protocol. At the six-month follow-up, 80% of participants were smoking-free.
Long-term follow-up of psilocybin-facilitated smoking cessation
This follow-up study (n=15) found that at 12 months 67% of participants didn't return to smoking (biologically confirmed). This was 60% at an average of 30-month follow-up. This study is the first (very positive) step in seeing if psilocybin-assisted psychotherapy (PAT) may be viable for people to quit smoking.