Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Johns Hopkins University
Sponsor:
Collaborators:
Beckley Foundation
Heffter Research Institute
Information provided by (Responsible Party):
Matthew Johnson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01943994
First received: September 12, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 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. Thirty additional participants will be enrolled and randomized to either psilocybin (n=15), or nicotine patch (n=15) 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 session monitors, participants will have either a single day-long psilocybin session using a high dose (30 mg/70 kg), or a standard 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, participants will undergo MRI scanning before and after Target Quit Date to assess the brain-based mechanisms associated with these treatments.


Condition Intervention
Nicotine Dependence
Drug: Psilocybin-assisted treatment
Drug: Nicotine Replacement Therapy (NRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Urinary cotinine [ Time Frame: At study intake, then at 3, 6, 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 13 weeks during active treatment, then at 3, 6, 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.

  • MRI scanning [ Time Frame: At 2 weeks (pre), 5 weeks (post), and 3 month follow up ] [ Designated as safety issue: No ]
    All 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.


Secondary Outcome Measures:
  • Blood cytokine [ Time Frame: At baseline (pre-treatment), and at 6 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 6 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.


Estimated Enrollment: 75
Study Start Date: September 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 (21mg daily for weeks 1-6, 14mg daily for weeks 7-8, 7mg daily for weeks 9-10).
Drug: Nicotine Replacement Therapy (NRT)
Other Names:
  • Transdermal Nicotine Patch
  • Nicoderm CQ

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 to 65 years old.
  • Be right-handed.
  • 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, caffeine, and alcohol for 24-hours prior to MRI scanning.
  • Agree to abstain from smoking for the psilocybin session from 1 hour before psilocybin administration until at least 2 hours after completing the next day's MRI scanning session.
  • 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.
  • Agree to participate in a paid sub-study protocol at NIDA IRP that will take approximately 4-6 hours to complete.
  • 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 fibrillation), 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.
  • More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
  • 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.
  • 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, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943994

Contacts
Contact: Albert P Garcia-Romeu, PhD 4105501972 AGarci33@jhmi.edu

Locations
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         
Sponsors and Collaborators
Johns Hopkins University
Beckley Foundation
Heffter Research Institute
Investigators
Principal Investigator: Matthew W Johnson, PhD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Matthew Johnson, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01943994     History of Changes
Other Study ID Numbers: NA_00016166
Study First Received: September 12, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Psilocybin
Smoking cessation

Additional relevant MeSH terms:
Nicotine
N,N-Dimethyltryptamine
Psilocybine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hallucinogens
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on October 19, 2014