Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01943994|
Recruitment Status : Recruiting
First Posted : September 17, 2013
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Psilocybin-assisted treatment Drug: Nicotine Replacement Therapy (NRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study|
|Actual Study Start Date :||September 2008|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Psilocybin-assisted treatment
Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a high dose of psilocybin (30mg / 70kg) to be administered on the Target Quit Date in week 5.
Drug: Psilocybin-assisted treatment
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 Name: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Active Comparator: Nicotine Replacement Therapy (NRT)
Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a standard 8 to 10-week regimen of NRT to be administered beginning on the Target Quit Date in week 5. NRT for this study will be a transdermal nicotine patch administered according to recommended label usage (For individuals who smoke more than 10 cigarettes per day: 21mg daily weeks 1-6, 14mg daily weeks 7-8, 7mg daily weeks 9-10. For individuals who smoke 10 or less cigarettes per day: 14mg daily for weeks 1-6, 7mg daily for weeks 7-8).
Drug: Nicotine Replacement Therapy (NRT)
- Urinary cotinine [ Time Frame: At study intake, then at 3, 6, and 12 month follow up. ]Urinary cotinine is a biological method used to verify smoking or non-smoking status of participants.
- Breath CO [ Time Frame: For 13 weeks during active treatment, then at 3, 6, and 12 month follow up. ]Breath Carbon Monoxide (CO) level is a biological method used to verify smoking or non-smoking status of participants.
- MRI scanning [ Time Frame: At 2 weeks (pre), 5 weeks (post), and 3 month follow up (for individuals still abstinent at this time point) ]50 participants will undergo MRI scanning in week 2 before their Target Quit Date, and in week 5 the day after their Target Quit Date. Participants who are biologically verified as smoking abstinent at 3-month follow-up will also complete an additional MRI scan at that time. For all MRI scanning sessions participants will be asked to refrain from smoking for 24 hours prior to the scan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|