Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: NA
Last verified: September 2013
History: No changes posted
  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 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.


Condition Intervention
Nicotine Dependence
Drug: Psilocybin-assisted treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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: 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 25
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)
Arms Assigned Interventions
Psilocybin-assisted treatment
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

  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
  • 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 for the first psilocybin session from 1 hour before psilocybin administration until 6 hours after psilocybin administration. Participants must have abstained from smoking for approximately 4 days before the second psilocybin 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 mornings of drug session days. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each 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
  • Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
  • 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.
  • More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
  • 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 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Psilocybin
Smoking cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
N,N-Dimethyltryptamine
Psilocybine
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on July 20, 2014