Cannabinoids for Menopause Symptoms

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Washington State University

Must not be taking: Antidepressants, Antianxiety, Antipsychotics

Disqualifiers: Severe depression, Psychosis, Chemotherapy, others

Prior Safety Data

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}

Research Team

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.

Trial 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 (Cannabinoids)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington State University - Pullman Campus Pullman, WA

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Patients Recruited

58,800+

Terra Mater Botanicals Pty Ltd

Collaborator

Trials

1

Patients Recruited

100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]