Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 3/1/2014 |
| Start Date: | January 2012 |
| End Date: | December 2013 |
| Contact: | Michael P. Bogenschutz, M.D. |
| Email: | mbogenschutz@salud.unm.edu |
| Phone: | 505-272-8428 |
This trial is an open-label pilot study (N = 10) designed to assess the effects of
psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated
behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.
Participants will receive psilocybin orally in two all-day administration sessions,
conducted in a secure outpatient psychiatric setting, in a dose range that has been
well-tolerated in recent studies. Psilocybin administration will occur in the context of a
behavioral intervention including a total of 12 sessions over 12 weeks, incorporating
Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on
Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as
preparation before and debriefing after the psilocybin administration sessions. The MET will
incorporate attention to spirituality as well as drinking behavior as a primary subject of
change. Drinking outcomes and changes in several potential mediators of treatment effect,
including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions
of the experience, will be measured during treatment and for 24 weeks after the end of
treatment. The investigators hypothesize that drinking will decrease following the
psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality
(primary contrast 12 weeks vs. baseline) will be observed among study participants.
psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated
behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.
Participants will receive psilocybin orally in two all-day administration sessions,
conducted in a secure outpatient psychiatric setting, in a dose range that has been
well-tolerated in recent studies. Psilocybin administration will occur in the context of a
behavioral intervention including a total of 12 sessions over 12 weeks, incorporating
Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on
Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as
preparation before and debriefing after the psilocybin administration sessions. The MET will
incorporate attention to spirituality as well as drinking behavior as a primary subject of
change. Drinking outcomes and changes in several potential mediators of treatment effect,
including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions
of the experience, will be measured during treatment and for 24 weeks after the end of
treatment. The investigators hypothesize that drinking will decrease following the
psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality
(primary contrast 12 weeks vs. baseline) will be observed among study participants.
Inclusion Criteria:
1. Males and females age 25-65 with SCID diagnosis of alcohol dependence;
2. Concerned about their drinking, but not planning to pursue any other form of
treatment at present (12-step meetings are not considered treatment);
3. Able to provide voluntary informed consent;
4. Having at least 2 heavy drinking days in the past 30 days;
5. Willing to commit to the goal of abstinence at least from the time of the first
psilocybin administration session until the end of treatment.
6. At least 24 hours abstinence from alcohol at the time of the psilocybin
administration sessions;
7. If female of childbearing potential, willing to use approved form of contraception
from screening until after the psilocybin administration sessions;
8. Having a family member or friend who can pick them up and stay with them overnight
after the psilocybin administration sessions; and
9. Able to provide adequate locator information.
Exclusion Criteria:
1. Exclusionary medical conditions (e.g., seizure disorder, significantly impaired liver
function, coronary artery disease, uncontrolled hypertension, history of
cerebrovascular accident, severe obesity (BMI greater than or equal to 35);
2. Exclusionary psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar
disorder, current major depression, current post-traumatic stress disorder, current
suicidality);
3. A family history of schizophrenia, schizoaffective disorder, bipolar disorder, or
suicide (first or second degree relatives);
4. Lifetime history of hallucinogen use on more than 10 occasions, or any use in the
past 30 days;
5. Cocaine, psychostimulant, or opioid dependence (past 12 months) or current (past 30
days) use;
6. A history of medically significant suicide attempt or violent crime;
7. Significant alcohol withdrawal (CIWA-Ar score greater than 7);
8. Exclusionary laboratory abnormalities (any liver function test (LFT) greater than 5
times normal, ECG evidence of ischemia, serious abnormalities of complete blood count
or chemistries);
9. Active legal problems with the potential to result in incarceration;
10. Pregnancy or lactation;
11. The need to take excluded medication (e.g., antidepressants, antipsychotics,
psychostimulants, pharmacologic treatments for addictions).
12. High risk of adverse emotional reaction based on investigator's clinical evaluation
(e.g., evidence of serious personality disorder, serious current stressors, lack of
meaningful social support).
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