THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia

Conditions

• Insomnia
• Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

25 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Placebo Administration — DRUG
  Given placebo tincture sublingually
• Single Agent Therapy — DRUG
  Given THC tincture sublingually
• Single Agent Therapy — DRUG
  Given THC/CBD tincture sublingually

Study Details

This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and insomnia. Many patients who are diagnosed with cancer struggle with sleep disorders after receiving a diagnosis. Insomnia is the most reported sleep disturbance amongst cancer patients, often stemming from physical changes from tumor growth and surgery, side effects from supportive care and chemotherapy, and stress associated with the diagnosis. THC with or without CBD may improve insomnia symptoms and sleep quality.

Key Dates

Start date

Jun 1, 2026

Status verified

Apr 2026

Primary completion

Sep 1, 2027

Completion

Sep 1, 2027

Study Design

Enrollment

69 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (THC tincture)
  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.
• Experimental: Arm II (THC/CBD tincture)
  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.
• Placebo Comparator: Arm III (placebo tincture)
  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.

Primary Outcome Measure

Change in Insomnia Sleep Index score [ Time Frame: From baseline to week 4 ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]
• Susie Lewis-Peters, RN
  507-266-1909

Locations (1)

Find similar trials in Rochester, MN

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