Anorexia NervosaEarly Phase 1NCT04878627
Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa
A Early Phase 1 study testing Cannabidiol in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must currently meet DSM-5 criteria for AN-R and AN Spectrum Disorders (i.e., Atypical AN) based on the Structured Clinical Interview for the DSM-5 (SCID-5-RV)
- Have a duration of illness ≥ 6 months
- Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician
Who cannot join
- Psychotic illness/other mental illness requiring inpatient hospitalization
- Current dependence on drugs or alcohol
- Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight or liver disease which may affect pharmacokinetics of the study drug
- Use of other psychoactive medications
- Significant changes in medication in past month
- Expression of acute suicidality
- Previous hypersensitivity reaction to Epidiolex or any of its constituents
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92121
About this study
Official title: The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics
No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section.
- Conditions
- Anorexia Nervosa
- Being tested
- Cannabidiol, Placebo
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex
patients receive cannabidiol at various doses for 3 weeks
PlaceboDrug
patients receive placebo for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | 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. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Committee of Clinical Investigations UKU-Side Effect Scale Week 1
The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects.
Measured: After completion of Week 1 of treatment
Committee of Clinical Investigations UKU-Side Effect Scale Week 2
The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects.
Measured: After completion of Week 2 of treatment
Committee of Clinical Investigations UKU-Side Effect Scale Week 3
The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects.
Measured: After completion of Week 3 of treatment
Blood tests for cannabinol (CBD) metabolites Week 1
Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.
Measured: After Completion of Week 1 of treatment
Blood tests for cannabinol (CBD) metabolites Week 2
Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.
Measured: After completion of Week 2 of treatment
Blood tests for cannabinol (CBD) metabolites Week 3
Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.
Measured: After completion of Week 3 of treatment
Change from baseline scores of Eating Disorder Examination Questionnaire (EDE-Q) over the course of treatment
Assesses the change from baseline in BMI, Eating Restraint, Eating Concern, Shape Concern, Weight Concern over the course of treatment. Each of those subscales is rated between 0 and 5. Subscales are calculated based on the average scores for the respective subscale. Higher scores indicate poorer outcome.
Measured: Weekly for the duration of the project (three weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start20 Jan 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, randomized, double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Frank, University of California, San Diego
- Investigators
- Guido K Frank, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878627
- Sponsor's protocol ID
- 191570
- Status last verified
- Aug 2025
- First submitted
- 26 Apr 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaye WH, Bulik CM, Thornton L, Barbarich N, Masters K. Comorbidity of anxiety disorders with anorexia and bulimia nervosa. Am J Psychiatry. 2004 Dec;161(12):2215-21. doi: 10.1176/appi.ajp.161.12.2215.
PubMed 15569892Ando T, Tamura N, Mera T, Morita C, Takei M, Nakamoto C, Koide M, Hotta M, Naruo T, Kawai K, Nakahara T, Yamaguchi C, Nagata T, Ookuma K, Okamoto Y, Yamanaka T, Kiriike N, Ichimaru Y, Ishikawa T, Komaki G; Japanese Genetic Research Group For Eating Disorders. Association of the c.385C>A (p.Pro129Thr) polymorphism of the fatty acid amide hydrolase gene with anorexia nervosa in the Japanese population. Mol Genet Genomic Med. 2014 Jul;2(4):313-8. doi: 10.1002/mgg3.69. Epub 2014 Feb 24.
PubMed 25077173Tambaro S, Bortolato M. Cannabinoid-related agents in the treatment of anxiety disorders: current knowledge and future perspectives. Recent Pat CNS Drug Discov. 2012 Apr 1;7(1):25-40. doi: 10.2174/157488912798842269.
PubMed 22280339Rong C, Lee Y, Carmona NE, Cha DS, Ragguett RM, Rosenblat JD, Mansur RB, Ho RC, McIntyre RS. Cannabidiol in medical marijuana: Research vistas and potential opportunities. Pharmacol Res. 2017 Jul;121:213-218. doi: 10.1016/j.phrs.2017.05.005. Epub 2017 May 10.
PubMed 28501518Bisogno T, Hanus L, De Petrocellis L, Tchilibon S, Ponde DE, Brandi I, Moriello AS, Davis JB, Mechoulam R, Di Marzo V. Molecular targets for cannabidiol and its synthetic analogues: effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide. Br J Pharmacol. 2001 Oct;134(4):845-52. doi: 10.1038/sj.bjp.0704327.
PubMed 11606325Sahota N, Grelotti DJ, Nguyen T, Kaye WH, Swindle S, Suhandynata R, Seely S, Shott ME, Frank GKW. Cannabidiol in Anorexia Nervosa: A Double-Blind Randomized Placebo Controlled Pilot Study to Test Safety, Pharmacokinetics, and Symptom Change. Int J Eat Disord. 2026 Jul;59(7):1576-1587. doi: 10.1002/eat.70034. Epub 2026 Mar 29.
PubMed 41906184
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT04878627
- Acronym / sponsor ID
- 191570
- Conditions
- Anorexia Nervosa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled, randomized, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: CannabidiolDays 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. |
| Placebo | Placebo comparator | Drug: PlaceboDays 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must currently meet DSM-5 criteria for AN-R and AN Spectrum Disorders (i.e., Atypical AN) based on the Structured Clinical Interview for the DSM-5 (SCID-5-RV)
- Have a duration of illness ≥ 6 months
- Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician
Key exclusion criteria (7 listed)
- Psychotic illness/other mental illness requiring inpatient hospitalization
- Current dependence on drugs or alcohol
- Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight or liver disease which may affect pharmacokinetics of the study drug
- Use of other psychoactive medications
- Significant changes in medication in past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: Epidiolexpatients receive cannabidiol at various doses for 3 weeks | Drug | Cannabidiol (CBD) |
| Placebopatients receive placebo for 3 weeks | Drug | Placebo |
Primary outcome
Committee of Clinical Investigations UKU-Side Effect Scale Week 1
Time frame: After completion of Week 1 of treatment
The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects.
Committee of Clinical Investigations UKU-Side Effect Scale Week 2
Time frame: After completion of Week 2 of treatment
The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects.
Committee of Clinical Investigations UKU-Side Effect Scale Week 3
Time frame: After completion of Week 3 of treatment
The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects.
Blood tests for cannabinol (CBD) metabolites Week 1
Time frame: After Completion of Week 1 of treatment
Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.
Blood tests for cannabinol (CBD) metabolites Week 2
Time frame: After completion of Week 2 of treatment
Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.
Blood tests for cannabinol (CBD) metabolites Week 3
Time frame: After completion of Week 3 of treatment
Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.
Change from baseline scores of Eating Disorder Examination Questionnaire (EDE-Q) over the course of treatment
Time frame: Weekly for the duration of the project (three weeks)
Assesses the change from baseline in BMI, Eating Restraint, Eating Concern, Shape Concern, Weight Concern over the course of treatment. Each of those subscales is rated between 0 and 5. Subscales are calculated based on the average scores for the respective subscale. Higher scores indicate poorer outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 15569892Kaye WH, Bulik CM, Thornton L, Barbarich N, Masters K. Comorbidity of anxiety disorders with anorexia and bulimia nervosa. Am J Psychiatry. 2004 Dec;161(12):2215-21. doi: 10.1176/appi.ajp.161.12.2215.
- Background: PubMed 25077173Ando T, Tamura N, Mera T, Morita C, Takei M, Nakamoto C, Koide M, Hotta M, Naruo T, Kawai K, Nakahara T, Yamaguchi C, Nagata T, Ookuma K, Okamoto Y, Yamanaka T, Kiriike N, Ichimaru Y, Ishikawa T, Komaki G; Japanese Genetic Research Group For Eating Disorders. Association of the c.385C>A (p.Pro129Thr) polymorphism of the fatty acid amide hydrolase gene with anorexia nervosa in the Japanese population. Mol Genet Genomic Med. 2014 Jul;2(4):313-8. doi: 10.1002/mgg3.69. Epub 2014 Feb 24.
- Background: PubMed 22280339Tambaro S, Bortolato M. Cannabinoid-related agents in the treatment of anxiety disorders: current knowledge and future perspectives. Recent Pat CNS Drug Discov. 2012 Apr 1;7(1):25-40. doi: 10.2174/157488912798842269.
- Background: PubMed 28501518Rong C, Lee Y, Carmona NE, Cha DS, Ragguett RM, Rosenblat JD, Mansur RB, Ho RC, McIntyre RS. Cannabidiol in medical marijuana: Research vistas and potential opportunities. Pharmacol Res. 2017 Jul;121:213-218. doi: 10.1016/j.phrs.2017.05.005. Epub 2017 May 10.
- Background: PubMed 11606325Bisogno T, Hanus L, De Petrocellis L, Tchilibon S, Ponde DE, Brandi I, Moriello AS, Davis JB, Mechoulam R, Di Marzo V. Molecular targets for cannabidiol and its synthetic analogues: effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide. Br J Pharmacol. 2001 Oct;134(4):845-52. doi: 10.1038/sj.bjp.0704327.
- Derived from this study: PubMed 41906184Sahota N, Grelotti DJ, Nguyen T, Kaye WH, Swindle S, Suhandynata R, Seely S, Shott ME, Frank GKW. Cannabidiol in Anorexia Nervosa: A Double-Blind Randomized Placebo Controlled Pilot Study to Test Safety, Pharmacokinetics, and Symptom Change. Int J Eat Disord. 2026 Jul;59(7):1576-1587. doi: 10.1002/eat.70034. Epub 2026 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido K Frank, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabidiol in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Committee of Clinical Investigations UKU-Side Effect Scale Week 1 (time frame: After completion of Week 1 of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878627, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.