THC vs THC/CBD for Insomnia in Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Benzodiazepines, Anticholinergics, Warfarin, others

Disqualifiers: Pregnancy, Primary sleep disorder, Cardiac disease, Psychotic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of THC alone or combined with CBD in improving sleep quality for patients with solid organ cancer who suffer from insomnia. Many cancer patients face sleep issues due to the physical and emotional effects of their condition and treatment. Participants will receive either a THC tincture, a THC/CBD tincture, or a placebo to determine which option best improves sleep. Individuals with a history of solid organ cancer (excluding certain brain cancers) who currently experience insomnia may qualify. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

You will need to stop using alcohol, anticholinergics, benzodiazepines, and any medications or supplements specifically for insomnia at least 7 days before starting the trial. If you are on opioids, your dose must be stable for at least 30 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that THC (tetrahydrocannabinol) is FDA-approved for uses such as aiding weight gain in AIDS patients and reducing nausea in cancer patients, indicating its general safety when used correctly. Past studies have demonstrated that THC and CBD (cannabidiol) together are usually safe and well-tolerated, especially compared to stronger painkillers like opioids.

For THC/CBD combinations, studies indicate they are generally safe with a low risk of dependence or abuse. However, research on THC and CBD for improving sleep remains mixed. Some studies show they help with sleep, while others suggest they might not be as effective.

In this trial phase, researchers are testing the treatments to better understand their safety and effectiveness, ensuring that any side effects are closely monitored. Overall, both THC and THC/CBD are considered relatively safe based on previous research, but individual responses can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for insomnia in cancer patients because they offer a new approach by utilizing cannabinoids. Unlike traditional medications like benzodiazepines or sedatives that often work by depressing the central nervous system, THC and THC/CBD tinctures work by interacting with the body's endocannabinoid system to potentially improve sleep quality. The combination of THC with CBD in one of the treatment arms is particularly interesting, as CBD may help counteract some of the psychoactive effects of THC, offering a balanced approach that could result in fewer side effects. Additionally, the sublingual administration allows for rapid absorption, which might provide quicker relief compared to oral medications.

What evidence suggests that this trial's treatments could be effective for insomnia in cancer patients?

This trial will compare the effects of THC alone and the combination of THC/CBD on sleep in cancer patients with insomnia. Research has shown that THC and CBD can improve sleep for cancer patients. In studies, patients using both THC and CBD reported an improvement in their sleep problems by about 1.87 points on a 0–10 scale. Another study found that these treatments significantly enhanced sleep quality compared to a placebo. Research on THC alone suggests it can help with sleep issues, particularly by improving breathing during sleep. Both THC and CBD have shown promise in helping people with insomnia sleep better and longer. These findings suggest that THC and the combination of THC/CBD could be promising options for improving sleep in cancer patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Stacy D. D'Andre, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults aged 25 or older with a history of solid organ cancer (not blood cancers) who are experiencing significant insomnia and want help. Participants must be medically stable, have certain minimum blood counts, and agree to avoid alcohol and some medications during the study.

Inclusion Criteria

I have trouble sleeping and want help for it.

* White blood cell count (WBC) ≥ 3,000/mm\^3 (obtained ≤ 30 days prior to randomization)

I am 25 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive THC, THC/CBD, or placebo tincture sublingually 60 minutes prior to bedtime for 28 days, with dose adjustments every 2 nights. Blood and urine samples are collected throughout the study.

5 weeks

Weekly visits for monitoring and sample collection

Titration

Participants titrate down to the lowest dose of THC, THC/CBD, or placebo tincture over 6 days.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of sleep quality and mood.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• THC
• THC/CBD

Trial Overview

The study compares three groups: one gets THC alone, another gets THC combined with CBD, and the third receives a placebo. The goal is to see which option best improves sleep quality in people with cancer-related insomnia.

How Is the Trial Designed?

Group I: Arm II (THC/CBD tincture) Experimental Treatment 2 Interventions

Patients receive THC/CBD tincture sublingually 60 minutes prior to bedtime QD on days 1-28. Patients start on day 1 at the lowest dose, for a minimum of 2 nights, and may increase the dose every 2 nights until they reach the maximum dose or they have acceptable sleep and remain at that dose. On days 29-34, patients continue to receive THC/CBD tincture sublingually 60 minutes prior to bedtime QD but titrate down to the lowest dose by day 34. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study.

Group II: Arm I (THC tincture) Experimental Treatment 2 Interventions

Patients receive THC tincture sublingually 60 minutes prior to bedtime QD on days 1-28. Patients start on day 1 at the lowest dose, for a minimum of 2 nights, and may increase the dose every 2 nights until they reach the maximum dose or they have acceptable sleep and remain at that dose. On days 29-34, patients continue to receive THC tincture sublingually 60 minutes prior to bedtime QD but titrate down to the lowest dose by day 34. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study.

Group III: Arm III (placebo tincture) Placebo Group 2 Interventions

Patients receive placebo tincture sublingually 60 minutes prior to bedtime QD on days 1-28. Patients start on day 1 at the lowest dose, for a minimum of 2 nights, and may increase the dose every 2 nights until they reach the maximum dose or they have acceptable sleep and remain at that dose. On days 29-34, patients continue to receive placebo tincture sublingually 60 minutes prior to bedtime QD but titrate down to the lowest dose by day 34. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1087079225001091

A systematic review and meta-analysis of randomised studies

Six trials (1077 patients) were included. Cannabinoids significantly improved sleep quality compared to placebo [SMD 0.53; 95 % CI 0.03–1.02; p = 0.04; I2 = 88 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC13009030/

The effects of tetrahydrocannabinol and cannabidiol on sleep ...

Sleep disturbance scores improved by 1.87 points on a 0–10 ordinal scale for cancer patients with CBD doses in the top quintile, and ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41120744/

The effects of tetrahydrocannabinol and cannabidiol on ...

Sleep disturbance scores improved by 1.87 points on a 0-10 ordinal scale for cancer patients with CBD doses in the top quintile, and ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07565974

THC Versus THC/CBD Versus Placebo to Improve Sleep ...

This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and ...

5.

researchgate.net

researchgate.net/publication/396758652_The_effects_of_tetrahydrocannabinol_and_cannabidiol_on_sleep_in_cancer_patients

(PDF) The effects of tetrahydrocannabinol and cannabidiol ...

Sleep disturbance scores improved by 1.87 points on a 0–10 ordinal scale for cancer patients with CBD doses in the top quintile, and approximately 1.5 points ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0012369222008959

Cannabinoids, Insomnia, and Other Sleep Disorders

This critical review summarizes the current evidence for the use of cannabinoids as a treatment for sleep disorders and provides an overview of endocannabinoid ...