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Trial record 1 of 1 for:    NCT01943994
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Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

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ClinicalTrials.gov Identifier: NCT01943994
Recruitment Status : Recruiting
First Posted : September 17, 2013
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
Beckley Foundation
Heffter Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 12, 2013
First Posted Date  ICMJE September 17, 2013
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE September 2008
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
  • Urinary cotinine [ Time Frame: For 15 weeks during active treatment, then at 6 month 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 15 weeks during active treatment, then at 6 month and 12 month follow up. ]
    Breath Carbon Monoxide (CO) level is a biological method used to verify smoking or non-smoking status of participants.
Change History Complete list of historical versions of study NCT01943994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
  • Blood cytokine [ Time Frame: At baseline (pre-treatment), and at 8 weeks. ]
    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. ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
Official Title  ICMJE Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
Brief 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. 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 for smoking cessation. 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, 2008). 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • 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
  • Drug: Nicotine Replacement Therapy (NRT)
    Other Names:
    • Transdermal Nicotine Patch
    • Nicoderm CQ
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Psilocybin-assisted treatment
  • 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).
    Intervention: Drug: Nicotine Replacement Therapy (NRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2017)
95
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2013)
25
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 21 to 65 years old.
  • Have given written informed consent.
  • Have a high school level of education.
  • Be a daily smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking.
  • Agree to abstain from smoking and alcohol for 24-hours, and caffeine for 12-hours prior to MRI scanning (for MRI participants only).
  • Agree to abstain from smoking for the psilocybin session from 1 hour before psilocybin administration until at least 30 hours afterwards.
  • Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of drug session day. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session day.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of psilocybin administration. Exceptions include caffeine and nicotine.
  • Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.

Exclusion Criteria:

  • Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
  • Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrilation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • Currently taking psychoactive prescription medication on a regular basis
  • Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are MAO inhibitors. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
  • Have HIV or Syphilis.
  • Have any current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma, or CNS tumor.
  • Morbidly obese, or severely underweight as determined by medical examination.
  • Not suitable to undergo an MRI session due to certain implanted devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology, or claustrophobia (for MRI participants only).
  • Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
  • Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression.
  • Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
  • Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, Major Depression, or Post-traumatic Stress Disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Albert P Garcia-Romeu, PhD 4105501972 AGarci33@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01943994
Other Study ID Numbers  ICMJE NA_00016166
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Beckley Foundation
  • Heffter Research Institute
Investigators  ICMJE
Principal Investigator: Matthew W Johnson, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP