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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cannabidiol (CBD) as a potential treatment for anorexia nervosa, a serious eating disorder. Researchers explore how different doses of CBD affect weight and eating behaviors, as well as treatment tolerance and possible side effects. CBD is under study because it might reduce anxiety, often linked to anorexia, and could help regulate the body's systems related to eating. The trial includes two groups: one receiving CBD and the other a placebo (a substance with no active ingredients). Individuals diagnosed with anorexia nervosa for at least six months and who are medically stable may be eligible to participate. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that cannabidiol (CBD) has not been specifically studied for anorexia nervosa (AN) yet. However, CBD is known to reduce anxiety, which might benefit individuals with AN. In past studies on other conditions, most participants have tolerated CBD well, though some experienced mild side effects such as fatigue, diarrhea, or changes in appetite and weight.

In this trial, participants will begin with a low dose of CBD, gradually increasing it. If side effects occur, the dose can be adjusted for participant comfort. As this is an early study, there is limited information on CBD's safety for individuals with AN. However, the FDA has approved CBD for other uses, indicating a known safety profile. This trial aims to explore how CBD might work for AN. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Anorexia Nervosa?

Most treatments for anorexia nervosa involve psychological therapy and nutritional counseling, sometimes supported by medications like antidepressants. But cannabidiol (CBD) offers a different approach. CBD is unique because it's derived from cannabis and is thought to interact with the body's endocannabinoid system, which plays a role in regulating appetite and mood. Researchers are excited about CBD because it could address both the psychological and physiological aspects of anorexia, potentially improving mood and stimulating appetite without the side effects typical of current medications. This novel mechanism of action and its potential for holistic benefits make CBD a promising candidate in the treatment landscape for anorexia nervosa.

What evidence suggests that CBD might be an effective treatment for Anorexia Nervosa?

Research suggests that cannabidiol (CBD), which participants in this trial may receive, might help with anorexia nervosa by reducing anxiety and possibly improving eating habits. Previous studies have shown that drugs affecting the body's natural chemical system, like CBD, could help manage symptoms of anorexia nervosa, such as excessive activity and weight loss. CBD is known for its calming effects and its ability to reduce anxiety, often linked to anorexia nervosa. Evidence also indicates that CBD may aid in weight gain and reduce symptoms of eating disorders. While the evidence is promising, more research is needed to confirm these effects specifically for anorexia nervosa. ^{3 6 7 8 9}

Who Is on the Research Team?

Guido K Frank, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10585887/

The relationship between cannabis and anorexia nervosa Cannabinoid treatment was associated with beneficial effects for AN, including weight gain, improved ED symptoms, and reduced PA urge; however, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04878627

Role of CBD in Regulating Meal Time Anxiety in Anorexia ... 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 ...

3. withpower.com withpower.com/trial/cbd-for-anorexia-nervosa-8a8fe

CBD for Anorexia Nervosa · Info for Participants Research suggests that drugs targeting the endocannabinoid system, like CBD, may help with anorexia nervosa by reducing hyperactivity and body weight loss, as ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0272735825000479

The differential effects of medicinal cannabis on mental ... A narrative review reported that THC and CBD were associated with reduced symptoms of anxiety, TS, anorexia nervosa, cannabis use disorder, and opioid use ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5678490/

A Systematic Review of the Effectiveness of Medical Cannabis ... Although results were inconsistent, there appears to be some low quality evidence of cannabinoids for anorexia nervosa, anxiety, PTSD, psychotic symptoms, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04878627

Role of CBD in Regulating Meal Time Anxiety in Anorexia ... No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established ...

7. cmcr.ucsd.edu cmcr.ucsd.edu/index.php/studies/completed-studies/228-frank-anorexia-nervosa

The Role of Cannabidiol (CBD) in Regulating Meal Time ... Our primary aim is to characterize CBD's pharmacokinetic and safety profile in patients with AN as well as the clinical effect of CBD on 1) anxiety; 2) on AN ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0261561425000597

The appetite stimulating effect and safety of delta-9 ... Cannabis-based medicine (CBM) with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) may have orexigenic properties in older patients with poor appetite.

9. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12622001306707

ANZCTR - Registration This trial will explore the safety and preliminary efficacy of Cannabidiol (CBD) as an adjunctive treatment in people with AN. Participants aged 12-65 years ...