PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Staci Gruber, Ph.D.
Study ID
NCT03984565
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol — DRUG
    High-CBD, low-THC sublingual product formulated in palm oil
  • Placebo — DRUG
    Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.

Study Details

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.

Key Dates

Start date
Jun 27, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cannabidiol Treatment Arm
    High-CBD sublingual product administered three times daily for the treatment period.
  • Placebo Comparator: Placebo Treatment Arm
    Placebo sublingual product administered three times daily for the treatment period.

Primary Outcome Measure

Change in pain ratings on a Numerical Rating Scale (NRS) [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Staci Gruber, PhD.
[email protected]
617-855-2762
Rosie Smith, M.S.
[email protected]
617-855-3338

Find similar trials in Belmont, MA

By research site
McLean Hospital· Belmont, MA

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