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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to examine the impact of the hemp-derived minor cannabinoids on symptoms of menopause/perimenopause.

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.

What data supports the effectiveness of the drug for menopause symptoms?

Some studies suggest that cannabis, which contains cannabinoids like THC, may help with symptoms such as insomnia and anxiety in perimenopausal and postmenopausal women. Additionally, cannabis is commonly used for pain relief, which might be beneficial for menopause-related discomfort. ^{1 2 3 4 5}

Is it safe to use cannabinoids or herbal products for menopause symptoms?

While some herbal products are used for menopause symptoms, safety concerns exist, especially regarding potential interactions with other medications and the lack of quality standards. For example, black cohosh, a common herbal remedy, has been linked to liver issues in some cases, so caution is advised, particularly for those with liver conditions. ^{6 7 8 9 10}

How does the Active Cannabinoid Product treatment differ from other menopause treatments?

The Active Cannabinoid Product is unique because it uses cannabinoids, which are compounds found in cannabis plants, to potentially alleviate menopause symptoms. Unlike traditional hormone replacement therapy, which involves estrogen, cannabinoids may offer a non-hormonal alternative that could help with symptoms like hot flashes and sleep disturbances. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

Sex differences and the endocannabinoid system in pain. [2022]

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

Sex differences in medical cannabis-related adverse effects. [2023]

3. England 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. [2023]

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

Effects of Oral Delta-9-Tetrahydrocannabinol in Women During the Follicular Phase of the Menstrual Cycle. [2023]

5. England 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. [2022]

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

Black cohosh (Actaea racemosa) for the mitigation of menopausal symptoms: recent developments in clinical safety and efficacy. [2016]

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

Complementary and alternative medications for women's health issues. [2010]

8. England pubmed.ncbi.nlm.nih.gov

Current alternative and complementary therapies used in menopause. [2009]

9. Ireland pubmed.ncbi.nlm.nih.gov

Assessing safety of herbal products for menopausal complaints: an international perspective. [2010]

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

Herbal therapies for perimenopausal and menopausal complaints. [2005]

11. England pubmed.ncbi.nlm.nih.gov

Associations among menopausal symptoms, sleep and fatigue in Taiwanese women with endometrial cancer. [2018]

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

Menopausal Symptoms and Their Management. [2022]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Hops for Menopausal Vasomotor Symptoms: Mechanisms of Action. [2022]

14. New Zealand pubmed.ncbi.nlm.nih.gov

A Review of Hormone and Non-Hormonal Therapy Options for the Treatment of Menopause. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Changes in physical symptoms during the menopause transition. [2023]