Trial Outcomes & Findings for Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence (NCT NCT01534494)

NCT ID: NCT01534494

Last Updated: 2023-09-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment
• Results posted on: 2023-09-26

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

Baseline characteristics by cohort

Measure	Psilocybin n=10 Participants 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.
Age, Continuous	40.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Percent Heavy Drinking Days at Screening	35.0006 Percentage STANDARD_DEVIATION 19.55541 • n=5 Participants

PRIMARY outcome

Timeframe: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Outcome measures

Measure	Psilocybin n=9 Participants 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.
Change in Percent Heavy Drinking Days	-25.962 percentage of days Standard Deviation 22.398

Adverse Events

Psilocybin

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Psilocybin n=10 participants at risk This was a single-arm study. All participants were assigned to receive the same schedule of psychotherapy and psilocybin administration, as described in the Protocol section. Arms/Groups cannot be provided for each dose level separately because information was not collected.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Injury, poisoning and procedural complications Forearm fracture	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Injury, poisoning and procedural complications Road traffic accident	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Nervous system disorders Headache	50.0% 5/10 • Number of events 5 • 32 weeks following first dose of psilocybin
Psychiatric disorders Alcohol withdrawal syndrome	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Psychiatric disorders Depression	10.0% 1/10 • Number of events 3 • 32 weeks following first dose of psilocybin
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • 32 weeks following first dose of psilocybin
Renal and urinary disorders Hematuria	10.0% 1/10 • Number of events 3 • 32 weeks following first dose of psilocybin

Additional Information

Michael Bogenschutz

New York University Grossman School of Medicine

Phone: 5059999325

Email: Michael.Bogenschutz@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place