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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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ after completion of week 3 of treatment

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

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met