Phase 2 Sleep Disorders Trial, Recruiting NCT06266611 Sponsor: University of Colorado, Boulder Condition: Sleep Disorders
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Phase 2 Sleep Disorders Trial, Recruiting

NCT06266611
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to give informed consent to participate
  • People who are 25 years of age or older at the first study visit
  • People who have been diagnosed with any type of solid tumour and who are currently receiving, or have received in the past 18 months, treatment aimed at either curing the cancer or managing its symptoms
  • People who are currently experiencing sleep problems, pain, and/or mood difficulties such as depression or anxiety
  • People who wish to use cannabis to help manage their symptoms
  • People who have not been using cannabis products regularly (more than 3 times per month) in the past 6 months
  • People who are willing to use an acceptable form of birth control for the duration of the study

Who may not be able to join:

  • People who have used illegal drugs such as cocaine or methamphetamine in the past 90 days
  • People who are currently taking anti-epilepsy medications (such as clobazam, sodium valproate, or lamotrigine)
  • People who are currently taking certain medications known to interact with the study drug Epidiolex (such as buprenorphine, sodium oxybate, or lomitapide — confirm full list with trial site)
  • People who are currently taking anti-psychotic medications
  • People who are currently taking certain medications that strongly affect how the body processes drugs, including rifampin, carbamazepine, phenytoin, St. John's wort, or phenobarbital (confirm full list with trial site)
  • People whose liver enzyme levels (ALT and AST) are significantly elevated above the normal range
  • People who have moderate or severe liver disease
  • People who have a personal or family history of psychosis, or who currently have a major psychiatric condition such as bipolar disorder, major depression, or schizophrenia
  • People who have a history of seizures
  • Women who are pregnant, breastfeeding, or trying to become pregnant during the study period; women of childbearing potential who do not have confirmed inability to become pregnant through menopause or surgical procedure (confirm details with trial site)
  • People whose treating doctor has indicated that participation in the trial would not be appropriate for them
  • People who are unwilling to avoid using cannabis products other than the study drug for the full duration of the study
  • Men who drink more than 2 alcoholic beverages per day, or women who drink more than 1 alcoholic beverage per day

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 603-769-7718

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Colorado, Boulder
Registry
ClinicalTrials.gov
Start date
16 September 2024
Est. completion
30 May 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pain Interference; Pain Intensity; Pain Inventory; Sleep Disturbance; Sleep-Related Impairment; Depression/Anxiety; Fatigue; Health Related Quality of Life; FACT-Cog Cognitive Function; Stroop Task Test of Cognitive Function; DSST Test of Cognitive Function; Conners Test of Cognitive Function; Plasma Cannabinoids; PROMIS Pain Intensity (Right Now); Drug Effects; ARCI-Marijuana Scale; Drug Effects - Mood; Drug Effects - Blood Cannabinoids

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov