SleepPhase 2CALMNCT07527338
Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
A Phase 2 study testing Cannabidiol in people with Sleep and Alcohol Misuse, run by University of Colorado, Boulder.
Trial summary
The goal of this clinical trial is to learn if cannabidiol helps to improve sleep and decrease alcohol use. It will also learn about the safety of cannabidiol. The main questions it aims to answer are: Does 4 weeks of nightly cannabdiol use: 1. improve sleep quality and time spent in REM sleep? 2. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep, Alcohol Misuse
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Apr 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Self reported poor sleep quality (PSQI score >5)
- Hazardous or harmful levels of alcohol consumption (MINI AUD score ≧2)
- No current moderate or severe alcohol withdrawal symptoms (CIWA-Ar)
- For female participants of childbearing potential: Not pregnant or lactating at the time of study enrollment or trying to become pregnant as confirmed by urine preg. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
- For female participants of childbearing potential: Agree to use a highly effective contraception method (i.e., a method with a failure rate of less than 1 percent per year when used consistently and correctly) starting at least five days before you begin the study and continuing for full participation.
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- No current use of sleep medications including CBD in the last 90 days
- No history of complicated alcohol withdrawal (i.e., seizure, delirium tremens, or alcohol hallucinosis).
- No current or past 6 months active suicidal ideation or suicidal behavior
- No current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
- No current cannabis use disorder (MINI SUD for cannabis score ≧2)
- History of previous exposure to guaiol through CBD or other cannabis product
Who cannot join
- Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
- Greater than low risk for obstructive sleep apnea (STOP-BANG <=4 or Moderate or greater risk as calculated by Nox Noxturnal Software from baseline PSG data)
- Current use of medications known to have major interactions with Epidiolex (e.g., brexanolone, buprenorphine, colchicine, esketamine, fezolinetant, ketamine, leflunomide, levoketoconazole, levomethadyl acetate, lomitapide, mipomersen, morphine, pexidartinib, pralsetinib, propoxyphene, relugolix, sodium oxybate, teriflunomide, and venetoclax)
- Current use of anti-psychotic medications
- Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
- History of hypersensitivity reactions to cannabidiol
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- Liver function test (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits at baseline
- Moderate or severe liver disease
- Allergy or aversion to gelatin (softgels contain porcine gelatin)
- Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days or positive screening on urine toxicology test at Baseline visit.
- Uncontrolled hypertension
- Blood pressure findings concerning for moderate or severe alcohol withdrawal at baseline
- Abnormal resting heart rate, defined as <60 bpm or >100 bpm at baseline
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if cannabidiol helps to improve sleep and decrease alcohol use. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:
Does 4 weeks of nightly cannabdiol use:
Read more
- improve sleep quality and time spent in REM sleep?
- decrease alcohol use and alcohol craving?
- pose any safety risks?
Researchers will compare cannabidiol to a placebo (a look-alike substance that contains no drug).
Participants will:
Take cannabidiol every night for 4 weeks Visit the clinic once at the beginning and once at the end of the study Wear an activity monitoring watch while in the study Complete an at-home sleep test both at the beginning and the end of the study Check in once a week with researchers via video conference
- Conditions
- Sleep, Alcohol Misuse
- Being tested
- Cannabidiol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
300mg broad spectrum hemp extract in 50mg softgels
PlaceboDrug
Taste and appearance matched softgel with hemp seed oil, glycerin, and gelatin
| Study group | Role | What they receive |
|---|---|---|
| 300mg oral cannabidiol | Experimental | Not described Receives: Drug: Cannabidiol |
| Placebo | Sham comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sleep Quality
Self reported sleep quality using the Patient Reported Outcomes Measurement Information Scale (PROMIS) Sleep Disturbance Subscale. The scale consists of eight items with a minimum score of eight and a maximum score of 40. Higher scores correspond to worse sleep quality.
Measured: 4 weeks
Alcohol Craving
Subjective report of alcohol craving using the Penn Alcohol Craving Scale. Scores range from 0 to 35, with higher scores corresponding to greater alcohol craving.
Measured: 4 weeks
Alcohol Use Frequency
Measure of frequency of alcohol use using the Timeline Followback
Measured: 4 weeks
Sleep Efficiency
A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch
Measured: 4 weeks
Total Sleep Time
An average of total time spent asleep each night as measured by a continuously worn actigraphy watch
Measured: 4 weeks
Time Spent in REM
Amount of time spent in the rapid eye movement sleep stage as measured by polysomnography
Measured: 4 weeks
Secondary outcomes (1)
Mood and Stress
Subjective report of symptoms of anxiety, depression, and stress using the Depression Anxiety Stress Scale (DASS). The DASS is a 21-item short-form measuring three related negative emotional states of depression, anxiety, and tension/stress. Scores for the entire measure range from 0 to 63, with higher scores corresponding to worse mood and stress outcomes. Subscales can also be scored individually (0-21).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renée Martin-Willett, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527338
- Sponsor's protocol ID
- 25-0483
- Acronym
- CALM
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
- ClinicalTrials.gov ID
- NCT07527338
- Acronym / sponsor ID
- CALM / 25-0483
- Conditions
- Sleep, Alcohol Misuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if cannabidiol helps to improve sleep and decrease alcohol use. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:
Does 4 weeks of nightly cannabdiol use:
- improve sleep quality and time spent in REM sleep?
- decrease alcohol use and alcohol craving?
- pose any safety risks?
Researchers will compare cannabidiol to a placebo (a look-alike substance that contains no drug).
Participants will:
Take cannabidiol every night for 4 weeks Visit the clinic once at the beginning and once at the end of the study Wear an activity monitoring watch while in the study Complete an at-home sleep test both at the beginning and the end of the study Check in once a week with researchers via video conference
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300mg oral cannabidiol | Experimental | Drug: Cannabidiol |
| Placebo | Sham comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to provide informed consent
- Self reported poor sleep quality (PSQI score >5)
- Hazardous or harmful levels of alcohol consumption (MINI AUD score ≧2)
- No current moderate or severe alcohol withdrawal symptoms (CIWA-Ar)
- For female participants of childbearing potential: Not pregnant or lactating at the time of study enrollment or trying to become pregnant as confirmed by urine preg. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
Key exclusion criteria (13 listed)
- Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
- Greater than low risk for obstructive sleep apnea (STOP-BANG <=4 or Moderate or greater risk as calculated by Nox Noxturnal Software from baseline PSG data)
- Current use of medications known to have major interactions with Epidiolex (e.g., brexanolone, buprenorphine, colchicine, esketamine, fezolinetant, ketamine, leflunomide, levoketoconazole, levomethadyl acetate, lomitapide, mipomersen, morphine, pexidartinib, pralsetinib, propoxyphene, relugolix, sodium oxybate, teriflunomide, and venetoclax)
- Current use of anti-psychotic medications
- Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol300mg broad spectrum hemp extract in 50mg softgels | Drug | 300mg oral cannabidiol |
| PlaceboTaste and appearance matched softgel with hemp seed oil, glycerin, and gelatin | Drug | Placebo |
Primary outcome
Subjective Sleep Quality
Time frame: 4 weeks
Self reported sleep quality using the Patient Reported Outcomes Measurement Information Scale (PROMIS) Sleep Disturbance Subscale. The scale consists of eight items with a minimum score of eight and a maximum score of 40. Higher scores correspond to worse sleep quality.
Alcohol Craving
Time frame: 4 weeks
Subjective report of alcohol craving using the Penn Alcohol Craving Scale. Scores range from 0 to 35, with higher scores corresponding to greater alcohol craving.
Alcohol Use Frequency
Time frame: 4 weeks
Measure of frequency of alcohol use using the Timeline Followback
Sleep Efficiency
Time frame: 4 weeks
A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch
Total Sleep Time
Time frame: 4 weeks
An average of total time spent asleep each night as measured by a continuously worn actigraphy watch
Time Spent in REM
Time frame: 4 weeks
Amount of time spent in the rapid eye movement sleep stage as measured by polysomnography
1 secondary outcome
Mood and Stress
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Sleep and Alcohol Misuse, run by University of Colorado, Boulder.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellie Sundali (720-378-8532, CALM.custudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sleep Quality (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.