Psilocybin and Spiritual Practice
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 21 - 70 |
Updated: | 4/21/2016 |
Start Date: | August 2009 |
End Date: | May 2014 |
Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior
This study will investigate the effects of psilocybin dose and the frequency and intensity
of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal
and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a
program of spiritual practices with the intention applying spiritual insights and knowledge
to everyday life. After screening and study enrollment, each volunteer will be assigned to
one of five groups that vary in dose, frequency and intensity of support for spiritual
practice, and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose
manipulation will be double-blind. Volunteers will be told that in each of sessions 1, 2,
and 3, he/she could receive a very low, low, moderate, moderately high, or high dose of
psilocybin. They will be told that each participant will receive 2 or more dose levels of
psilocybin over the 2 or 3 sessions, and all participants will have one or more sessions in
which he or she receives a moderately high or high dose of psilocybin. The duration of each
volunteer's participation will be approximately 6 to 8 months. Each volunteer will receive
several hours of preparation with the study guides in the month prior to the first
psilocybin session; the first two sessions will be separated by one month. Various measures
will be assessed before, during and immediately after sessions. A battery of longitudinal
measures will be evaluated immediately after study enrollment, 3 weeks after the second
psilocybin session, and 4 months after the second psilocybin session (6 months after study
enrollment). For purposes of controlling expectancies through the 6 month follow-up
evaluation, volunteers and guides will not know which volunteers or how many volunteers will
be scheduled for a third session.
of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal
and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a
program of spiritual practices with the intention applying spiritual insights and knowledge
to everyday life. After screening and study enrollment, each volunteer will be assigned to
one of five groups that vary in dose, frequency and intensity of support for spiritual
practice, and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose
manipulation will be double-blind. Volunteers will be told that in each of sessions 1, 2,
and 3, he/she could receive a very low, low, moderate, moderately high, or high dose of
psilocybin. They will be told that each participant will receive 2 or more dose levels of
psilocybin over the 2 or 3 sessions, and all participants will have one or more sessions in
which he or she receives a moderately high or high dose of psilocybin. The duration of each
volunteer's participation will be approximately 6 to 8 months. Each volunteer will receive
several hours of preparation with the study guides in the month prior to the first
psilocybin session; the first two sessions will be separated by one month. Various measures
will be assessed before, during and immediately after sessions. A battery of longitudinal
measures will be evaluated immediately after study enrollment, 3 weeks after the second
psilocybin session, and 4 months after the second psilocybin session (6 months after study
enrollment). For purposes of controlling expectancies through the 6 month follow-up
evaluation, volunteers and guides will not know which volunteers or how many volunteers will
be scheduled for a third session.
Eligibility criteria for volunteers who will receive psilocybin
Inclusion Criteria:
- 21 to 70 years old
- Have given written informed consent
- Have a high school level of education
- Be healthy and psychologically stable as determined by screening for medical and
psychiatric problems via a personal interview, a medical questionnaire, a physical
examination, an electrocardiogram (ECG), and routine medical blood and urinalysis
laboratory tests.
- Have an active interest in exploring and developing their spiritual lives
- Cigarette smokers must agree to abstain from smoking on psilocybin session days from
1 hour before psilocybin administration until at least 6 hours after psilocybin
administration.
- 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.
- Agree not to take any PRN medications on the mornings of psilocybin sessions
- Agree that for one week before each psilocybin session, he/she will refrain from
taking any nonprescription medication, nutritional supplement, or herbal supplement
except when approved by the study investigators. Exceptions will be evaluated by the
study investigators and will include acetaminophen, non-steroidal anti-inflammatory
drugs, and common doses of vitamins and minerals.
Exclusion Criteria:
General medical exclusion criteria:
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at
intake and before each drug session) or nursing; women who are of child-bearing
potential and sexually active who are not practicing an effective means of birth
control
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled
hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation),
or TIA in the past year
- 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 (e.g., daily)
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
Psychiatric Exclusion Criteria:
- 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 Anorexia Nervosa, Bulimia Nervosa, or other
psychiatric conditions judged to be incompatible with establishment of rapport or
safe exposure to psilocybin
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Baltimore, Maryland 21224
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