Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use

ConditionsSleep Alcohol Misuse

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21+

SponsorUniversity of Colorado, Boulder

About this trial

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. decrease alcohol use and alcohol craving? 3. 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Cannabidiol
Drug
300mg broad spectrum hemp extract in 50mg softgels
Placebo
Drug
Taste and appearance matched softgel with hemp seed oil, glycerin, and gelatin

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: 300mg oral cannabidiolExperimental treatment 1 intervention

Group B: PlaceboSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

4 weeks

Alcohol Use Frequency

Measure of frequency of alcohol use using the Timeline Followback

Time frame

4 weeks

Sleep Efficiency

A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch

Time frame

4 weeks

Secondary outcomes

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).

Time frame

4 weeks

Other outcomes

Alcohol Withdrawal

Safety monitoring of alcohol withdrawal symptoms using the Combine Systematic Assessment for the Treatment of Emergent Effects

Time frame

4 weeks

Alcohol Withdrawal

Safety monitoring of alcohol withdrawal symptoms using the Revised Clinical Institute Withdrawal Assessment of Alcohol Scale

Time frame

4 weeks

Risk for Self-Injurious Behaviors

Safety monitoring of risk for behaviors related to self-injury or suicide as measured by the Columbia Suicide Severity Rating Scale (C-SSRS). It includes five 'yes/no' items and follow-up interview items examining ideation intensity and characterization of suicidal behaviors. Research is mixed on whether a combined score (ideation and behavior) is meaningful on the C-SSRS. For the purposes of this study, any score greater than 0 is considered clinically significant. Suicidal ideation is defined by a scores of 'yes' on any items 1-5 and suicidal behavioral correspondents to 'yes' on any items 6-10.

Time frame

4 weeks

Blood levels of alanine transaminase and aspartate transaminase

Safety monitoring of liver functioning for as determined by levels of alanine transaminase (ALT) and aspartate transaminase (AST) in blood samples. The upper limit of normal functioning typical for both AST and ALT for men is 35-40 units per liter (U/L) and 25-30 U/L for women.

Time frame

4 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Boulder

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: