Psilocybin-facilitated Treatment for Chronic Pain

Conditions

• Fibromyalgia, Primary

Eligibility Criteria

Sex

FEMALE

Age

25 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Psilocybin — DRUG
  0.36 mg/kg will be administered orally to participants
• Dextromethorphan — DRUG
  2.6 mg/kg of active placebo will be administered orally to participants

Study Details

The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients.

Key Dates

Start date

Nov 1, 2023

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Psilocybin
  Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.
• Active Comparator: Active Placebo
  Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).

Primary Outcome Measure

Change in daily self-reported pain severity [ Time Frame: through study completion, up to 13 weeks ]

Central Contacts

• Peter Hendricks, Ph.D.
  205-202-1387
  [email protected]

Locations (1)

Find similar trials in Birmingham, AL

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• Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
  Recruiting · Brown University · Providence, Rhode Island