CBD for Anorexia Nervosa

Overseen By Megan E Shott, BS

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of California, San Diego

Must not be taking: Psychoactive medications

Disqualifiers: Psychotic illness, Drug dependence, Diabetes, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants do not use other psychoactive medications. If you are currently taking such medications, you may need to stop them to participate in the study.

What data supports the effectiveness of the drug CBD for treating anorexia nervosa?

Research suggests that drugs targeting the endocannabinoid system, like CBD, may help with anorexia nervosa by reducing hyperactivity and body weight loss, as seen in animal studies. Additionally, cannabinoids have shown positive outcomes in related conditions, such as post-traumatic stress disorder, indicating potential benefits for anorexia nervosa. ^{1 2 3 4 5}

Is CBD generally safe for human use?

CBD is generally considered safe for human use, but it can cause side effects like sleepiness, changes in appetite, and stomach issues. It may also interact with other medications, so it's important to monitor its use, especially if you are taking other drugs. ^{1 6 7 8 9}

How does the drug CBD differ from other treatments for anorexia nervosa?

CBD is unique because it acts on the endocannabinoid system and serotonin receptors, potentially offering benefits like reducing anxiety and improving mood, which are not the primary focus of traditional anorexia treatments. ^{8 10 11 12 13}

Research Team

Guido K Frank, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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.

Inclusion Criteria

My illness has lasted for 6 months or more.

Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician

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)

Exclusion Criteria

You have expressed thoughts of wanting to harm or kill yourself recently.

I have a condition like diabetes or liver disease that can affect my eating, weight, or how my body handles medication.

My medications have not changed significantly in the past month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBD or placebo in increasing doses over three weeks

3 weeks

Weekly visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol

Trial Overview 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.

Participant Groups

Group I: Cannabidiol (CBD) Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

Cannabidiol (CBD) has been associated with significant adverse events, particularly 'weight decreased', 'hypophagia', and 'insomnia', based on a disproportionality analysis of reports from the VigiBase® database involving various patients.

The interaction of CBD with the serotonin 5-HT1A receptor may explain the occurrence of insomnia, highlighting the need for careful monitoring of these side effects in patients using CBD for conditions like Lennox-Gastaut syndrome and Dravet syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. Calapai, F., Mannucci, C., McQuain, L., et al.[2023]

High oral doses of cannabidiol (CBD), specifically 300-400 mg per day, have shown efficacy in reducing anxiety and providing anti-addiction effects without increasing adverse effects, based on a review of interventional studies.

Therapeutic benefits of CBD are less clear at lower doses (below 300 mg/day), indicating a need for larger clinical trials to better understand the potential effects of low-dose CBD products, which are widely available as nutraceuticals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of low oral doses of cannabidiol: An evaluation of the evidence. Arnold, JC., McCartney, D., Suraev, A., et al.[2023]

In a study involving both male and female rats with depressive-like behaviors, oral administration of Cannabidiol (CBD) at 30 mg/kg showed a pro-hedonic effect, increasing the preference for sweet solutions in female Wistar Kyoto rats, similar to previous findings in males.

CBD also significantly reduced immobility in the forced swim test for both male and female WKY rats, indicating its potential as a treatment for mental disorders characterized by feelings of helplessness and lack of pleasure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol in males and females in two different rat models of depression. Shbiro, L., Hen-Shoval, D., Hazut, N., et al.[2020]

A clinical case study of a male patient with schizophrenia and substance use disorders showed that using CBD cigarettes with low THC content (<1%) helped reduce his cravings for high-THC cannabis and led to a cessation of cocaine use.

After 8 years of frequent hospitalizations due to psychotic relapses and substance use, the patient has not been hospitalized since starting the CBD treatment, suggesting that CBD may be a promising adjunctive therapy for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: CBD Cigarettes for Harm Reduction and Adjunctive Therapy in a Patient With Schizophrenia and Substance Use Disorder. Meyer, M., Walter, M., Borgwardt, S., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The relationship between cannabis and anorexia nervosa: a scoping review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dronabinol in severe, enduring anorexia nervosa: a randomized controlled trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Cannabinoid CB1 /CB2 receptor agonists attenuate hyperactivity and body weight loss in a rat model of activity-based anorexia. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Activity-based anorexia in C57/BL6 mice: effects of the phytocannabinoid, Delta9-tetrahydrocannabinol (THC) and the anandamide analogue, OMDM-2. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Effects of Oral Cannabidiol: An Updated Systematic Review of Randomized Controlled Trials (2020-2022). [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The safety and efficacy of low oral doses of cannabidiol: An evaluation of the evidence. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Cannabidiol for neurodegenerative disorders: important new clinical applications for this phytocannabinoid? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol in males and females in two different rat models of depression. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in an adolescent with multiple substance abuse, social anxiety and depression. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: CBD Cigarettes for Harm Reduction and Adjunctive Therapy in a Patient With Schizophrenia and Substance Use Disorder. [2021]