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Cannabinoid

CBD for Anorexia Nervosa

Phase < 1
Waitlist Available
Led By Guido K Frank, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a duration of illness ≥ 6 months
Be between 18 and 65 years old
Must not have
Use of other psychoactive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for the duration of the project (three weeks)

Summary

This trial is investigating whether cannabidiol (CBD), a component of marijuana, is an effective treatment for Anorexia Nervosa (AN).

Who is the study for?
This trial is for individuals with Anorexia Nervosa or related disorders, who have been ill for at least 6 months and are medically stable. Participants must meet specific diagnostic criteria without significant medication changes recently. Those with certain physical conditions, drug dependencies, or severe mental health issues cannot join.
What is being tested?
The study tests the effects of Cannabidiol (CBD) on mealtime anxiety in people with Anorexia Nervosa. It aims to establish CBD's dosage, side effects, tolerability, and acceptability as a potential treatment by comparing it against a placebo.
What are the potential side effects?
Potential side effects of CBD may include mild digestive upset, changes in appetite or mood, drowsiness or fatigue. However, since this is an exploratory study, part of its purpose is to document the range and frequency of any side effects experienced.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My illness has lasted for 6 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication that affects my mood or thinking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after completion of week 3 of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after completion of week 3 of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood tests for cannabinol (CBD) metabolites Week 1
Blood tests for cannabinol (CBD) metabolites Week 2
Hematologic Tests
+4 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
29%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol (CBD)Experimental Treatment1 Intervention
Days 1 to 7: Patients will receive CBD 2.5 mg/kg in divided doses BID for 7 days. Days 8 to 14: Patients will receive an increase dose of 7.5 mg/kg of CBD in divided doses. Days 15 to 21: Patients will receive an increased dose of 12.5 mg/kg CBD, in divided doses. If patients experience dose limiting side-effects, they ill be maintained on the lowest tolerated dose.
Group II: PlaceboPlacebo Group1 Intervention
Days 1 to 7: Patients will receive placebo in divided doses BID for 7 days. Days 8 to 14: Patients will continue to receive placebo in divided doses. Days 15 to 21: Patients will receive continue to receive placebo in divided doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,006 Total Patients Enrolled
18 Trials studying Anorexia Nervosa
1,865 Patients Enrolled for Anorexia Nervosa
Guido K Frank, MDPrincipal InvestigatorUniversity of California, San Diego

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04878627 — Phase < 1
Anorexia Nervosa Research Study Groups: Cannabidiol (CBD), Placebo
Anorexia Nervosa Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT04878627 — Phase < 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878627 — Phase < 1
~1 spots leftby Jan 2025