A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence

Who is this study for? Patients with alcohol dependence
What treatments are being studied? Psilocybin
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: f
View:

• Males and females age 25-65 with SCID (DSM-IV) diagnosis of alcohol dependence who

• Want to stop or decrease their drinking

• Are not participating in any formal treatment for alcohol dependence (12-step meetings are not considered treatment)

• Are able to provide voluntary informed consent

• Have at least 4 heavy drinking days in the past 30 days

• If female of childbearing potential, are willing to use approved form of contraception from screening until after the psilocybin administration sessions

• Have a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions

• Are able to provide adequate locator information.

Locations
United States
New Mexico
University of New Mexico Health Sciences Center
Albuquerque
New York
Clinical and Translational Science Institute, NYU Langone Medical Center
New York
Time Frame
Start Date: 2014-06
Completion Date: 2021-07-30
Participants
Target number of participants: 95
Treatments
Experimental: Psilocybin
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Active_comparator: Diphenhydramine
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Sponsors
Collaborators: University of New Mexico, Heffter Research Institute
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov