Alcohol Use Disorder study: Cannabidiol
Official title Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
ClinicalTrials.gov ID: NCT07148843
What this study is testing
What is Cannabidiol (CBD)?
This is an investigational medicine being studied to see if it can help with alcohol withdrawal symptoms and cravings. It is designed to interact with the body's endocannabinoid system, which helps regulate mood, sleep, and stress responses.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding CBD to standard care can improve withdrawal symptoms and lower cravings during early recovery.
- Who it's for
- The study is looking for adults with moderate-to-severe alcohol use disorder who are ready to stop drinking.
- What's involved
- Participants will stay in a hospital research unit for 5 days, receive either CBD or a placebo along with standard care, and complete tests for withdrawal and sleep.
- Time commitment
- The study requires a 5-day, 4-night inpatient stay at Johns Hopkins Hospital.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder
- Age 21-65
- Report at least one prior episode of alcohol withdrawal symptoms at least one day in duration that caused significant impairment in functioning...
- Report at least 21 days of heavy drinking (four or more drinks for women, five or more drinks for men) over the last 28 days.
- Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen
You likely can't join if
- Current or past alcohol-related medical complications including but not limited to cirrhosis of the liver, esophageal varices, pancreatitis, severe...
- Use of gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week prior to admission
- Regular use (i.e. twice a week or more) of CBD-dominant products, including Epidiolex®, within the last three months
- Regular use of benzodiazepines (e.g., twice a week or more) within the last three months
- Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including moderate-to-severe Cannabis Use Disorder (except for alcohol- and...
- Urine drug screen indicating the presence of substances other than cannabis at screening.
See the full eligibility criteria
- Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder
- Age 21-65
- Report at least one prior episode of alcohol withdrawal symptoms at least one day in duration that caused significant impairment in functioning (i.e., unable to attend work or engage in typical activities) AND/OR...
- Report at least 21 days of heavy drinking (four or more drinks for women, five or more drinks for men) over the last 28 days.
- Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen
- Agree to use a highly effective method of contraception (e.g. hormonal contraception, intrauterine device, double-barrier method) for at least five days prior to administration of the study drug and throughout the...
- Shipley vocabulary score \> 18, corresponding to 5th grade reading level.
- Demonstrated understanding of informed consent and ability to consent to participation in the study.
- Current or past alcohol-related medical complications including but not limited to cirrhosis of the liver, esophageal varices, pancreatitis, severe gastritis, hemoptysis, hematochezia, or melena.
- Use of gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week prior to admission
- Regular use (i.e. twice a week or more) of CBD-dominant products, including Epidiolex®, within the last three months
- Regular use of benzodiazepines (e.g., twice a week or more) within the last three months
- Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including moderate-to-severe Cannabis Use Disorder (except for alcohol- and tobacco-related disorders)
- Urine drug screen indicating the presence of substances other than cannabis at screening.
- Active suicidal ideation or recent suicide attempts (e.g. within six months)
- Unstable and/or compromising medical or psychiatric conditions that would interfere with participant safety as determined by study physician.
- Current pregnancy
- BMI \<18.5 kg/m2
- History of anorexia nervosa or bulimia in the past 2 years
- History of seizures or seizure disorder outside of alcohol-withdrawal related seizures
- History of complicated alcohol withdrawal (e.g. seizures, delirium tremens) as verified by medical record review if available
- Mean systolic blood pressure (SBP) \>/= 140 mm Hg, DBP \>/= 90 mmHg or pulse \>/= 110 mm Hg during screening
- Mean systolic blood pressure (SBP) \>/=160 mm Hg, DBP\>/=110 mm Hg, or pulse \>/=120 mm Hg during pre-admission at Behavioral Pharmacology Research Unit (BPRU) prior to admission to CRU
- AST \> 165 U/L (normal range 19-55)
- ALT \> 216 U/L (normal range 19-72)
- Alkaline phosphatase \> 1.5x upper limit of normal (ULN) (normal range 38-126)
- Total bilirubin \>1.5 ULN (normal values=0.3-1.0 mg/dL)
- Non-fasting glucose \> 250 mg/ml (normal range 65-179)
- Hematocrit \< 38 % (normal range 41-53)
- Hemoglobin \< 12 g/dl (normal range 13.5-17.5) or any other laboratory value significantly outside the normal range
- Use of a prescription medication (except for birth control prescriptions) within 14 days of study entry, which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the...
- Use of prescription medications, OTC medications, herbal medications, and/or dietary supplements that are strong inducers of CYP3A4 or CYP2C19 within 14 days or 5 half-lives (whichever is longer) prior to study drug...
- ECG with QT-corrected interval (QTc) \> 450 ms and/or presence of clinically significant abnormality
- Participation in other clinical trials within the past 60 days
- Court-mandated participation in alcohol treatment or pending incarceration.
- Known chronic liver disease or cirrhosis of any etiology (e.g. autoimmune, infections, Metabolic Dysfunction-Associated Steatohepatitis [MASH]]) except in the following cases: 1.
- Recent acute hepatitis of any etiology (e.g. drug-induced hepatitis, hepatitis A infection within the past six months)
- Moderate to severe hepatic impairment (Child-Pugh Class B and C)
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.