Alcohol Dependence
Conditions
Keywords
alcohol dependence, psilocybin, clinical trial, motivational enhancement therapy
Brief summary
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.
Interventions
DRUGPsilocybin
two doses of 0.3 mg/kg PO and 0.4 mg/kg PO, separated by 4 weeks in combination with 12 weeks of manualized outpatient psychosocial treatment including preparation, debriefing, and motivational enhancement therapy.
Sponsors
Heffter Research Institute
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females age 25-65 with diagnosis of alcohol dependence, as ascertained using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV version); 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Percent Heavy Drinking Days | weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psilocybin Psilocybin: two doses of 0.3 mg/kg PO and 0.4 mg/kg PO, separated by 4 weeks in combination with 12 weeks of manualized outpatient psychosocial treatment including preparation, debriefing, and motivational enhancement therapy. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Psilocybin |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent Heavy Drinking Days at Screening | 35.0006 Percentage STANDARD_DEVIATION 19.55541 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Percent Heavy Drinking Days
Time frame: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psilocybin | Change in Percent Heavy Drinking Days | -25.962 percentage of days | Standard Deviation 22.398 |
Comparison: Single-group pre-post contrastp-value: 0.008t-test, 2 sided