Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
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. We 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 in smoking cessation treatment. Prior work in our laboratory has shown that under carefully prepared and supportive conditions, psilocybin administration can facilitate highly salient experiences with enduring personal meaning and spiritual significance (Griffiths et al., 2006). 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, we propose to conduct a pilot study in which psilocybin is 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. Ten participants will complete this pilot study. After several preparation meetings with session monitors, participants will have three day-long psilocybin sessions (the second and third sessions will be approximately 2 weeks and 6 weeks after the first session, respectively). Participants will be administered 20 mg/70 kg psilocybin in the first session and 30 mg/70 kg psilocybin in the second and third sessions. Participants will meet with session monitors the day after each session, two additional times between the first and second psilocybin sessions, and weekly for 8 weeks after the second session to discuss the session experiences and to provide support for smoking cessation. Participant smoking status will be assessed repeatedly for 8 weeks after the second psilocybin session, including biological verification of smoking status through breath and urine samples. Smoking status will also be assessed at two follow up sessions approximately 6 months and 12 months after the second psilocybin session.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study|
- Urinary cotinine [ Time Frame: For 15 weeks during active treatment, then at 6 month and 12 month follow up. ] [ Designated as safety issue: No ]Urinary cotinine is a biological method used to verify smoking or non-smoking status of participants.
- Breath CO [ Time Frame: For 15 weeks during active treatment, then at 6 month and 12 month follow up. ] [ Designated as safety issue: No ]Breath Carbon Monoxide (CO) level is a biological method used to verify smoking or non-smoking status of participants.
- Blood cytokine [ Time Frame: At baseline (pre-treatment), and at 8 weeks. ] [ Designated as safety issue: No ]In order to assess the hypothesis that spiritual experience or smoking cessation is associated with changes in immune function or stress hormones, blood samples at baseline and 1 week after the second psilocybin session will be collected for cytokine and hormonal analyses.
- Cortisol [ Time Frame: At baseline (pre-treatment), and at 8 and 14 weeks. ] [ Designated as safety issue: No ]Diurnal saliva samples of cortisol will be assessed at baseline, 1 week after the second psilocybin session, and 1 week after the third psilocybin session as a biological marker of stress.
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
As this is an open-label pilot study, the treatment arm is the only arm of study participants.
Drug: Psilocybin-assisted treatment
In the first session, participants will be administered 20 mg/70 kg psilocybin. The dose on the second and third sessions will be 30 mg/70 kg. Preliminary evidence from our ongoing psilocybin dose-effects study suggests that both of these doses are associated with mystical-type experiences, with some variability across participants. The use of both doses is intended to increase the odds of participants having a mystical-type experience on at least one session. The investigators may designate the second and/or third session dose as 20 mg/70 kg instead of 30 mg/70 kg for any particular individual if an optimal response was achieved at 20 mg/70 kg in the first session.
Other Name: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943994
|Contact: Albert P Garcia-Romeu, PhD||4105501972||AGarci33@jhmi.edu|
|United States, Maryland|
|Behavioral Pharmacology Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Albert P Garcia-Romeu, PhD 410-550-1972 AGarci33@jhmi.edu|
|Principal Investigator: Matthew W Johnson, PhD|
|Sub-Investigator: Roland R. Griffiths, PhD|
|Principal Investigator:||Matthew W Johnson, PhD||Johns Hopkins University|