Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07296094
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Psilocybin is administered in oral capsule form during two dosing sessions held four weeks apart. Each session occurs in a controlled clinical environment with continuous monitoring by trained study therapists. Participants receive a standardized psychotherapy protocol that includes preparatory sessions before dosing and integration sessions afterward. The randomized dosing schedule includes either 10 mg with optional escalation to 15 mg or 30 mg with optional escalation to 40 mg for the second session. All participants also receive support from a peer recovery coach and are offered ongoing outpatient addiction treatment throughout the study period.

Study Details

This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 1, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low Dose Psilocybin
    Participants randomized to this arm receive psilocybin in capsule form at a dose of 10 mg during the first dosing session, with the option to increase to 15 mg at the second session. Doses are administered orally under direct supervision in a controlled clinical setting and paired with the same standardized psychotherapy protocol used in the high-dose arm. Participants complete two dosing sessions four weeks apart and receive ongoing support from a peer recovery coach and optional outpatient addiction treatment.
  • Experimental: Full Dose Psilocybin
    Participants randomized to this arm receive psilocybin in capsule form at a dose of 30 mg during the first dosing session, with the option to increase to 40 mg at the second session. Doses are administered orally under direct supervision in a controlled clinical setting and paired with a standardized psychotherapy protocol, including preparatory and integration sessions. All participants complete two dosing sessions spaced four weeks apart and receive ongoing support from a peer recovery coach and optional outpatient addiction treatment.

Primary Outcome Measure

Percent Heavy Drinking Days [ Time Frame: Weeks 0-24 following the first psilocybin dosing session. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Anika E Clinical Research Coordinator, BS
[email protected]
617-525-0676
Aishwarya Senior Program Coordinator, MS
[email protected]

Find similar trials in Boston, MA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Brigham and Women's Hospital· Boston, MA

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