Cannabinoids for Menopause Symptoms

Overseen By Carrie Cuttler, Ph.D., Psychology

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Washington State University

Must not be taking: Antidepressants, Antianxiety, Antipsychotics

Disqualifiers: Severe depression, Psychosis, Chemotherapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how hemp-derived cannabinoids might alleviate menopause or perimenopause symptoms. Participants will receive either a placebo or an active cannabinoid product (a treatment derived from cannabis) to assess symptom improvement. The trial seeks individuals born female, aged 40-60, experiencing menopause or perimenopause, who do not regularly use cannabis. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you have not changed your medication in the past 3 months and are not currently taking anti-depressant, anti-anxiety, or antipsychotic medications. If you meet these criteria, you can continue your current medications.

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

Research has shown that cannabinoids are usually safe for people, even in large amounts. Although many studies have confirmed their safety, individual reactions can vary, and interactions with other medications may occur.

Specific research on using cannabinoids for menopause symptoms remains limited, but they are generally considered safe based on their use for other conditions. More studies are needed to confirm their safety for menopause. Prospective trial participants should consult their doctor to ensure the trial is safe based on their health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for menopause symptoms?

Unlike standard treatments for menopause symptoms, which often involve hormone replacement therapy (HRT) or antidepressants, the active cannabinoid product under study is derived from cannabis and targets the body's endocannabinoid system. Researchers are excited about this treatment because it offers a new mechanism of action that could potentially address a wide range of menopause symptoms, from hot flashes to mood swings, with fewer side effects compared to HRT. Additionally, cannabinoids may provide benefits for sleep and anxiety, which are common issues during menopause but not always effectively managed with traditional treatments.

What evidence suggests that this treatment might be an effective treatment for menopause symptoms?

Research has shown that many women find cannabinoids helpful for menopause symptoms. In a survey, about 73.5% of women reported relief from issues like trouble sleeping and anxiety after using cannabis. Specifically, 67% experienced better sleep, and 46% noticed improvements in other menopause-related problems. However, experts note that limited information exists on the safety and effectiveness of cannabinoids for treating hot flashes. This trial will compare an active cannabinoid product with a placebo to further investigate its effects on menopause symptoms. While cannabinoids appear promising for some menopause symptoms, more research is needed to fully understand their effects. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 40-60 who are going through perimenopause or menopause, don't use cannabis regularly, and haven't changed their medications or supplements recently. They must be able to consent, own a smartphone, and have Zoom access. Excluded are those pregnant, with psychosis history, severe depression, on certain mental health meds, using illicit drugs/alcohol heavily, traveling extensively soon or undergoing chemotherapy.

Inclusion Criteria

I am capable of understanding and consenting to participate.

My medications have not changed in the last 3 months.

Abstinent from regular cannabis use (<1x/month) for the past year, and willing to abstain from use for 3 months

Exclusion Criteria

Pregnant or breastfeeding

Psychosis or family history of psychosis

I have low blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Baseline

Participants complete four weeks of baseline assessments via ecological momentary assessment (EMA) and cognitive tests

4 weeks

Weekly virtual assessments

Phase 1

Participants take a single dose of the active or placebo product twice a day and complete EMA survey assessments

4 weeks

Daily virtual assessments

Phase 2

Participants may increase the dose of the product and continue EMA survey assessments

4 weeks

Daily virtual assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Cannabinoid Product

Trial Overview

The study is testing the effects of hemp-derived cannabinoids versus a placebo on menopausal symptoms. Participants will either receive the active cannabinoid product or a placebo without knowing which one they're taking to measure the true impact of the treatment.

How Is the Trial Designed?

Group I: Active Arm Experimental Treatment 1 Intervention

Participants in this arm will receive an active product.

Group II: Placebo Arm Placebo Group 1 Intervention

Participants in this arm will receive a placebo.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Terra Mater Botanicals Pty Ltd

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Menopause symptoms, particularly vasomotor symptoms like hot flushes and night sweats, affect 50% to 80% of middle-aged women and are linked to estrogen deficiency, highlighting the need for effective management strategies such as hormone replacement therapy (HRT).

Herbal treatments containing compounds like 8-prenylnaringenin from hops have shown promise in reducing menopause symptoms, with clinical trials indicating significant reductions in hot flush frequency, although more extensive studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hops for Menopausal Vasomotor Symptoms: Mechanisms of Action. Abdi, F., Mobedi, H., Roozbeh, N.[2022]

In a study of 8,623 Australian women aged 45 to 50, those in the perimenopausal stage reported higher rates of symptoms like tiredness, stiff joints, and difficulty sleeping compared to premenopausal and postmenopausal women.

Postmenopausal women experienced more hot flushes and night sweats, with the likelihood of these symptoms increasing as women transitioned through menopause stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in physical symptoms during the menopause transition. Brown, WJ., Mishra, GD., Dobson, A.[2023]

The use of herbal therapies for perimenopausal and menopausal symptoms is increasing among women in the U.S., raising concerns about their safety and quality due to the lack of government standards for herbal products.

Clinicians need to be informed about the use, quality, and safety of these herbal therapies, as many products may be unsafe or lack scientific backing for their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal therapies for perimenopausal and menopausal complaints. Israel, D., Youngkin, EQ.[2005]

In a study involving women tested during different phases of their menstrual cycle, responses to oral THC (7.5 and 15 mg) were largely similar, suggesting that varying estrogen levels do not significantly affect THC's effects.

However, women in the early follicular phase reported wanting more of the drug and experienced anxiety slightly earlier after THC administration, indicating some nuanced differences in subjective responses based on hormonal levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Oral Delta-9-Tetrahydrocannabinol in Women During the Follicular Phase of the Menstrual Cycle. Pabon, E., de Wit, H.[2023]

Menopausal hormone therapy (MHT) is shown to be safe and effective for treating vasomotor symptoms in women under 60 years old and within 10 years of menopause, provided they do not have significant cardiometabolic issues.

Both hormonal and non-hormonal treatment options are available for menopausal symptoms, and the choice of therapy should be tailored to individual risk profiles and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Hormone and Non-Hormonal Therapy Options for the Treatment of Menopause. Madsen, TE., Sobel, T., Negash, S., et al.[2023]

Certain complementary and alternative medicine (CAM) therapies, like clonidine, SSRIs, and gabapentin, have been found effective in reducing menopausal symptoms, while phytoestrogens and black cohosh show inconsistent results.

Many commonly used remedies, such as ginseng and evening primrose oil, do not effectively relieve hot flushes, and there is a need for more rigorous long-term studies to better understand the efficacy and safety of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current alternative and complementary therapies used in menopause. Wong, VC., Lim, CE., Luo, X., et al.[2009]

Women frequently turn to alternative treatments like herbs and dietary supplements for various health issues, including menstrual pain and menopause symptoms.

There is a lack of well-designed clinical trials assessing the safety and efficacy of these alternative treatments, making it challenging to provide reliable, evidence-based recommendations for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative medications for women's health issues. Lloyd, KB., Hornsby, LB.[2010]

In a study of 429 patients with chronic noncancer pain, women reported more adverse effects from medical cannabis than men, despite similar weight-adjusted doses of cannabis consumed by both sexes.

The differences in adverse effects may be linked to the specific phytocannabinoid compositions consumed by women, who used higher doses of CBD and CBC, suggesting that tailoring cannabis treatments based on sex could improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in medical cannabis-related adverse effects. Aviram, J., Lewitus, GM., Vysotski, Y., et al.[2023]

In a study of 95 women with endometrial cancer, menopausal symptoms, particularly sexual pain, were found to be significantly worse in those who underwent surgical menopause compared to those with natural menopause.

The study revealed that 55% of participants experienced poor sleep quality, and higher levels of fatigue were linked to worse sleep and menopausal symptoms, highlighting the need for healthcare providers to assess these factors to improve quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations among menopausal symptoms, sleep and fatigue in Taiwanese women with endometrial cancer. Li, CC., Tsai, YF., Chang, TC., et al.[2018]

Menopausal symptoms, particularly vasomotor symptoms like hot flashes, vaginal dryness, sleep difficulties, and mood changes, can significantly impact women's health as they transition through menopause.

Cognitive changes in postmenopausal women are more closely linked to aging rather than hormonal changes, suggesting that treatment strategies should focus on managing other menopausal symptoms rather than expecting hormonal therapy to address cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menopausal Symptoms and Their Management. Santoro, N., Epperson, CN., Mathews, SB.[2022]

Clinical trials generally support the efficacy of black cohosh in alleviating menopause-related symptoms, although some studies show contradictory results.

There have been at least 50 reported cases of possible liver toxicity associated with black cohosh, prompting caution for menopausal women with liver issues or those on liver-affecting medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Black cohosh (Actaea racemosa) for the mitigation of menopausal symptoms: recent developments in clinical safety and efficacy. Mahady, GB., Doyle, B., Locklear, T., et al.[2016]

Long-term safety assessments of herbal products for menopausal women are crucial, as these products may be used for extended periods alongside prescription medications.

To ensure consumer safety, there must be regulatory frameworks that verify the identity and quality of herbal ingredients, assess their safety and effectiveness, and monitor for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing safety of herbal products for menopausal complaints: an international perspective. Dog, TL., Marles, R., Mahady, G., et al.[2010]

Research indicates that there are significant sex differences in how cannabinoids affect pain relief, with female rodents showing greater sensitivity to Δ9-THC, which may be influenced by hormonal factors and differences in cannabinoid receptor expression.

Understanding these sex differences in cannabinoid pharmacology is crucial for optimizing cannabis use for pain management in both men and women, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences and the endocannabinoid system in pain. Blanton, HL., Barnes, RC., McHann, MC., et al.[2022]

A survey of 1485 women aged 35 and over in Alberta, Canada, revealed that 34% currently use cannabis, primarily for medical reasons related to menopause symptoms such as sleep issues, anxiety, and muscle/joint pain.

Among current cannabis users, 74% reported that it was helpful for managing their menopause symptoms, indicating a potential therapeutic role for cannabis, though further research is needed to evaluate its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use for menopause in women aged 35 and over: a cross-sectional survey on usage patterns and perceptions in Alberta, Canada. Babyn, K., Ross, S., Makowsky, M., et al.[2023]

Only three studies were found that specifically evaluated the effects of cannabis use on menopausal symptoms in women, indicating a significant lack of research in this area.

While some studies suggest that cannabis may be associated with alleviating symptoms like hot flashes and insomnia, there is currently insufficient evidence to support its efficacy, highlighting the need for more comprehensive research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of cannabis use on vasomotor symptoms, mood, insomnia and sexuality in perimenopausal and postmenopausal women: a systematic review. Mejia-Gomez, J., Phung, N., Philippopoulos, E., et al.[2022]

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Does CBD oil work for menopause symptoms?

Despite its popularity, cannabidiol (CBD) is controversial. Here, learn about the safety and potential benefits of using CBD to ease menopause symptoms.