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Résztvevőt keres itt: Egyesült Államok1/2. fázis

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

A legfontosabb adatok

Ki végzi
Florida A&M University
Hol
Tallahassee (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
1/2. fázis
Résztvevők
20 fő, tervezett
Kezdés
2026. ápr. 2.
Várható befejezés
2027. jún. 30.
A vizsgálat típusa
Beavatkozással járó, 4 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • Cannabidiol (CBD) oral solution
  • Full-Spectrum CBD hemp extract oral solution
  • Placebo in MCT oil oral solution
A regiszteradat frissítve
2026. április 29.

Ki vehet részt

Életkor
40 év – 70 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 34 feltétel megnézéseKevesebb

Ki vehet részt

  • Adult aged 40 to 70 years
  • Diagnosis of Type 2 Diabetes
  • Ambulatory and independently living adult
  • Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg)
  • Physical exam completed within the previous 6 months
  • Liver Function Studies (ALT and AST) completed within the previous six months showing normal values
  • If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN)
  • DN4 questionnaire results indicate mild to moderate DPN
  • Nerve Conduction Test (NCT) confirms at least mild DPN
  • Signed ICF/Screening Consent
  • Able to complete required questionnaires (adequate vision)

Ki nem vehet részt

  • History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke
  • Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring
  • Diagnosis of a major depressive episode with active suicidal ideation and/or a plan to attempt suicide within the previous 5 years
  • Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years
  • Taking medications that are known to cross-reacting with CBD or Cannabiods
  • High-risk or severely ill individuals (e.g., high risk for general anesthesia, significant limitations due to heart/lung disease, ascites, renal failure, loss of limbs from diabetic complications)
  • Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction)
  • Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence)
  • Severe or uncontrolled liver disease (e.g., cirrhosis, active viral hepatitis A, B, or C, autoimmune hepatitis, uncontrolled primary biliary cholangitis or primary sclerosing cholangitis)
  • Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome)
  • History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers)
  • History of a seizure disorder
  • Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic/hypomanic episode, or psychosis)
  • Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN
  • Blindness (poor vision preventing questionnaire completion)
  • Reproductive Health (Women Only)
  • Currently pregnant or lactating
  • Women who can get pregnant who are not using acceptable methods of birth control
  • Attempted suicide in the last 10 years
  • C-SSRS Suicide Ideation Subscore ≥5 at study onset
  • HADS-D score ≥15 at study onset
  • Used cannabis products in the past 30 days
  • Heavy drinking (≥8 drinks/week for women; ≥15 drinks/week for men)

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 40 és 70 év között vagy?

Helyszínek itt: Egyesült Államok

  • the FSU TMH Family Practice Residency ProgramTallahassee, Egyesült ÁllamokContact: Justin LeeRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The "Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot study (CBD-DPN1)" is a double-blinded, placebo-controlled, crossover pilot study evaluating the efficacy of Cannabidiol (CBD) and full-spectrum CBD (fsCBD) tinctures in treating Diabetic Peripheral Neuropathy (DPN)-associated pain. DPN is a common, highly distressing complication of diabetes, characterized by chronic pain and loss of sensory function, for which currently available treatments primarily offer only symptomatic relief. CBD and fsCBD are being investigated for their potential neuroprotective and analgesic effects by regulating inflammation and oxidative stress.

A teljes eredeti leírásKevesebb

The study aims to recruit 12 to 20 adult participants who have mild to moderate DPN. Subjects will receive either an active treatment (CBD isolate or fsCBD in MCT oil, dosed at 50 mg twice daily for a total of 100 mg daily) or a placebo during two sequential 6-week phases. The overall objective of this pilot phase is primarily methodological: to test and refine the clinical protocol, assess patient compliance and acceptability of the CBD formulations, and generate sufficient data to calculate the necessary sample size for a larger, definitive study. Efficacy will be measured using objective and subjective metrics, including DPN severity (DN4 Assessment Tool and DPNCheck™ for nerve conduction velocity) and pain level (PainDetect Questionnaire). Secondary outcomes include evaluating mood (HADS), sleep quality (MOS Sleep Scale), and quality of life (EQ-5D-5L).

A vizsgálat 4 csoportja

  • 1. CBD Isolate Phase 1 (Placebo Phase 2)A vizsgált kezelés

    Participants randomized to Arm 1 will be given CBD Isolate tincture 100 mg/ml (50 mg twice daily for a total of 100 mg daily) for 6 weeks in Phase 1. After a 2-week washout period they will be given an identical appearing placebo tincture for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.1

    Kezelés: Cannabidiol (CBD) oral solution

  • 2. Placebo Phase 1 (CBD Isolate Phase 2)Placebo, összehasonlításként

    Participants randomized to Arm 2 will be given a placebo tincture (0.5 ml twice daily for a total of 1 ml daily) for 6 weeks in Phase 1. After a 2-week washout period, they will be given the active tincture containing 100 mg of CBD isolate (100 mg/ ml) to use 0.5 ml twice daily for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

    Kezelés: Placebo in MCT oil oral solution

  • 3. CBD Full-spectrum Phase 1 (Placebo Phase 2)A vizsgált kezelés

    Participants randomized to Arm 3 will be given a Full-spectrum CBD isolate tincture with 100 mg of hemp-derived CBD isolate /ml (using 0.5 ml; 50 mg twice daily for a total of 100 mg daily) for 6 weeks in Phase 1. After a 2-week washout period they will be given an identical appearing placebo tincture for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

    Kezelés: Full-Spectrum CBD hemp extract oral solution

  • 4. Placebo Phase 1 (CBD Full-spectrum Phase 2)Placebo, összehasonlításként

    Participants randomized to Arm 4 will be given a placebo tincture (0.5 ml twice daily for a total of 1 ml daily) for 6 weeks in Phase 1. After a 2-week washout period, they will be given the active tincture containing 100 mg of CBD Full-spectrum isolate (100 mg/ ml) to use 0.5 ml twice daily for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

    Kezelés: Placebo in MCT oil oral solution

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Illeszkedési kérdések
Forrás: NCT07298408: ki vehet részt
A regiszteradat frissítve
2026. április 29.