Alcohol Use Disorder (AUD)Phase 2/3NCT07148843
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
A Phase 2/3 study testing Cannabidiol (CBD) in people with Alcohol Use Disorder (AUD) and Withdrawal From Addictive Substance; Detoxification, run by Johns Hopkins University at 1 site in United States.
Trial summary
Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification, Craving
- What is being tested?
- Cannabidiol (CBD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2026to 31 Oct 2030
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 required medications to manage symptoms.
- 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.
- if female of childbearing potential who has not had a sterilization procedure:
- Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen
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- 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 duration of the study
- Shipley vocabulary score > 18, corresponding to 5th grade reading level.
- Demonstrated understanding of informed consent and ability to consent to participation in the study.
Who cannot join
- 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.
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- 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
- Any of the following laboratory values during screening or upon admission:
- 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 subject. This includes any medication in which CYP2C9, CYP2C19, CYP1A2, CYP2B10, or CYP3A4 enzymes are major metabolizers. Participants taking medications that are substrates of UDP-glucuronosyltransferase 1-9 (UGT1A9), UDP-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and/or P-gp wll be allowed into the study but closely monitored for potential adverse events based on the prescribing information of the concomitant medications given CBD's potential to inhibit these enzymes.
- 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 administration
- 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. Fully resolved hepatitis B infection (HBsAg negative, anti-Hepatitis C core antibody (anti-HBc) and/or anti-Hepatitis B surface antibody (anti-HBs) positive, with normal liver function tests) or 2. Successfully treated hepatitis C infection (HCV RNA negative, with normal liver function tests and no evidence of advanced fibrosis or cirrhosis)
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
David Wolinsky, MD, 410-550-2253, dwolins2@jhmi.edu
Elise Weerts, PhD, 410-550-2781, eweerts@jhmi.edu
About this study
Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.
Read the detailed description
Alcohol withdrawal during acute abstinence represents a major health threat to millions of individuals struggling with alcohol use disorder (AUD): it has been associated with complications in patients admitted for medically supervised withdrawal including seizures and delirium tremens (the latter of which can be fatal if not managed appropriately) and can interfere with treatment efforts. Benzodiazepines, such as lorazepam (Ativan) represent the first-line treatments for control of alcohol withdrawal, yet higher doses of benzodiazepines required to manage more complicated withdrawal cases increase risk of respiratory depression and delirium. Furthermore, a growing frequency of benzodiazepine shortages (at least 20 shortages within the previous ten years lasting a median of 244 days) necessitates a need for alternative and adjunctive medications. Preclinical animal trials involving cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) have shown its use is associated with statistically significant reductions in withdrawal symptoms and there is evidence in non-AUD populations that CBD is effective in reducing anxiety, insomnia, and seizures, which are all symptoms of alcohol withdrawal. The capacity for CBD to enhance the effect of the inhibitory neurotransmitter Gama-aminobutyric acid (GABA) in a manner akin to benzodiazepines has also been demonstrated. Collectively this information suggests that CBD could alleviate signs and symptoms of alcohol withdrawal, and subsequently reduce the need for adjunctive benzodiazepines.
This randomized placebo-controlled clinical trial will enroll adults with moderate-to-severe AUD who will be admitted to an inpatient research unit at the Johns Hopkins Hospital for management of their alcohol withdrawal. Enrolled participants with a history of alcohol withdrawal symptoms will be randomized to receive an oral formulation of either placebo or one of two CBD doses (10 mg/kg or 20 mg/kg). These doses have been well-studied and tolerated in prior studies and clinical trials for other disorders. Alcohol withdrawal symptoms, as defined by Diagnostic and Statistical Manual (DSM-5) criteria, will be assessed by nursing administration of the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) and participant completion of the Alcohol Withdrawal Symptom Checklist (AWSC). The CIWA-Ar scale will be used to guide the administration of symptom-triggered lorazepam (trade name Ativan) for all participants. As insomnia is a DSM-5 criterion for alcohol withdrawal, sleep quality will be assessed by completion of the Consensus Sleep Diary (CSD) and wrist actigraphy. Last, since cravings correlate closely with withdrawal symptoms and CBD has been observed to reduce craving for other substances, we will explore CBD's impact on alcohol craving by having participants complete the Alcohol Urge Questionnaire throughout the study. In short, the goals of this study will be to (1) determine the effect of CBD on physiologic and subjective symptoms of alcohol withdrawal, (2) determine the capacity of CBD to improve insomnia and disordered sleep during withdrawal, and (3) determine if CBD can attenuate alcohol cravings during acute abstinence.
Results from this study can help inform the possible use of CBD as a novel adjunct treatment for alcohol withdrawal and cravings that may reduce benzodiazepine need for alcohol withdrawal treatment. If CBD is shown to be effective, this line of work also points to the potential of the endogenous cannabinoid system playing a mechanistic role in alcohol's withdrawal symptoms. Finally, this study could provide further insights into the efficacy of CBD as a sleep agent for participants with alcohol withdrawal and lay the groundwork for subsequent studies exploring CBD's use in the treatment of alcohol withdrawal in an outpatient setting.
- Being tested
- Cannabidiol (CBD), Placebo
- Keywords
- alcohol abstinence, alcohol withdrawal treatment, detoxification
- Medical subject headings
- Alcoholism, Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
Cannabidiol
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 10 mg/kg CBD | Active comparator | low dose CBD Receives: Drug: Cannabidiol (CBD) |
| 20 mg/kg CBD | Active comparator | high dose CBD Receives: Drug: Cannabidiol (CBD) |
| placebo | Placebo comparator | Placebo (no CBD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)
The Alcohol Withdrawal Symptom Checklist (AWSC) is a validated measure in which participants report their own withdrawal symptoms. The scale consists of 17 items. The total possible score is 0-68, with higher scores indicating more severe withdrawal symptoms. The highest score for a participant across the duration of their time on the Clinical Research Unit (CRU) will be included in the analysis.
Measured: Four times daily during inpatient stay (4 nights)
Peak score on the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)
The Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) is a clinically administered measurement that represents the gold standard for assessing the severity of withdrawal symptoms. It consists of 10-items: nausea/ vomiting, tremor, paroxysmal sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation/clouding of sensorium. Each sign and symptom is rated on a Likert scale from 0-7 (with 0=absent and 7 =most severe), except for "clouding of sensorium," which is ranked from 0 to 4. Scores on the CIWA-Ar scale range from 0 to 67, with higher scores indicating more severe withdrawal. The highest score for a participant across the duration of their time on the CRU will be included in the analysis. Clinical staff will use these scores to justify administration of benzodiazepines to treat withdrawal symptoms.
Measured: 4 times daily during inpatient stay (4 nights)
Average total sleep time (minutes) and wake after sleep onset as measured by wrist actigraphy
Actigraphy will provide a primary assessment of sleep outcomes including total sleep time and wake after sleep onset. The actigraphy devices used will be triaxial accelerometers from Generation model 9 (GT9X) Link Wrist Actigraphy, Actigraph LLC. Values for total sleep time and wake time after sleep onset will be averaged across the study's four nights; this average will be included in the analysis.
Measured: 4 nights during inpatient stay
Peak alcohol craving as measured by scores on the Alcohol Urge Questionnaire (AUQ)
The Alcohol Urge Questionnaire (AUQ) is an eight-item self-report questionnaire that has demonstrated validity and discriminative value in identifying and measuring alcohol craving. Each item is ranked on a score of 0 to 7, with a maximum score range of 0- 56. Higher scores indicate greater craving. The highest score for a participant across the duration of their time on the CRU will be included in the analysis.
Measured: Four times daily during inpatient stay (4 nights)
Secondary outcomes (8)
Average Total Sleep Time (minutes) as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure in which participants rate features of their sleep-average total sleep time. Generally higher number is better.
Measured: Upon waking each morning during inpatient stay (4 days)
Total Amount of Time (minutes) on Awakenings, as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure in which participants rate features of their sleep- total amount of time on awakenings. Higher number indicating more awakenings (worse).
Measured: Upon waking each morning during inpatient stay (4 days)
Sleep Quality as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure consisting of nine items in which participants rate features of their sleep--sleep quality either "Very Poor," "Poor," "Fair," "Good," or "Very Good"
Measured: Upon waking each morning during inpatient stay (4 days)
Sleep Latency (minutes) as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure consisting of nine items in which participants rate features of their sleep - sleep latency (how long it takes one to fall asleep). Higher values would indicate worse sleep latency.
Measured: Upon waking each morning during inpatient stay (4 days)
Number of Awakenings as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure consisting of nine items in which participants rate features of their sleep--number of awakenings. Higher number indicating more awakenings (worse).
Measured: Upon waking each morning during inpatient stay (4 days)
Total amount of time (minutes) spent awake after sleep onset as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure consisting of nine items in which participants rate features of their sleep-- total amount of time spent awake after sleep onset. higher values indicating more time awake (worse).
Measured: Upon waking each morning during inpatient stay (4 days)
Total doses of lorazepam administered
Lorazepam (trade name: Ativan) is a benzodiazepine that is frequently used in clinical practice to manage alcohol withdrawal symptoms. Since the decision to administer lorazepam is guided by CIWA scores, it can serve as a proxy for severity of withdrawal symptoms. Every four hours daily as needed for CIWA scores >/=10 while the participant stays on the inpatient Johns Hopkins Hospital (JHH) CRU
Measured: Every 4 hours during inpatient stay (4 nights)
Serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes that act as proxies for hepatic function and damage. Elevations in the serum levels (U/L) of these enzymes--particular at levels >/= 3 times the upper limit of normal--can indicate liver injury.
Measured: Morning prior to admission, morning of discharge (day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start21 Oct 2026
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David Woliinsky, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148843
- Sponsor's protocol ID
- IRB00519608
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
- ClinicalTrials.gov ID
- NCT07148843
- Acronym / sponsor ID
- IRB00519608
- Keywords
- alcohol abstinence, alcohol withdrawal treatment, detoxification
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 29 Aug 2025 (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.
Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.
Detailed description
Alcohol withdrawal during acute abstinence represents a major health threat to millions of individuals struggling with alcohol use disorder (AUD): it has been associated with complications in patients admitted for medically supervised withdrawal including seizures and delirium tremens (the latter of which can be fatal if not managed appropriately) and can interfere with treatment efforts. Benzodiazepines, such as lorazepam (Ativan) represent the first-line treatments for control of alcohol withdrawal, yet higher doses of benzodiazepines required to manage more complicated withdrawal cases increase risk of respiratory depression and delirium. Furthermore, a growing frequency of benzodiazepine shortages (at least 20 shortages within the previous ten years lasting a median of 244 days) necessitates a need for alternative and adjunctive medications. Preclinical animal trials involving cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) have shown its use is associated with statistically significant reductions in withdrawal symptoms and there is evidence in non-AUD populations that CBD is effective in reducing anxiety, insomnia, and seizures, which are all symptoms of alcohol withdrawal. The capacity for CBD to enhance the effect of the inhibitory neurotransmitter Gama-aminobutyric acid (GABA) in a manner akin to benzodiazepines has also been demonstrated. Collectively this information suggests that CBD could alleviate signs and symptoms of alcohol withdrawal, and subsequently reduce the need for adjunctive benzodiazepines.
This randomized placebo-controlled clinical trial will enroll adults with moderate-to-severe AUD who will be admitted to an inpatient research unit at the Johns Hopkins Hospital for management of their alcohol withdrawal. Enrolled participants with a history of alcohol withdrawal symptoms will be randomized to receive an oral formulation of either placebo or one of two CBD doses (10 mg/kg or 20 mg/kg). These doses have been well-studied and tolerated in prior studies and clinical trials for other disorders. Alcohol withdrawal symptoms, as defined by Diagnostic and Statistical Manual (DSM-5) criteria, will be assessed by nursing administration of the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) and participant completion of the Alcohol Withdrawal Symptom Checklist (AWSC). The CIWA-Ar scale will be used to guide the administration of symptom-triggered lorazepam (trade name Ativan) for all participants. As insomnia is a DSM-5 criterion for alcohol withdrawal, sleep quality will be assessed by completion of the Consensus Sleep Diary (CSD) and wrist actigraphy. Last, since cravings correlate closely with withdrawal symptoms and CBD has been observed to reduce craving for other substances, we will explore CBD's impact on alcohol craving by having participants complete the Alcohol Urge Questionnaire throughout the study. In short, the goals of this study will be to (1) determine the effect of CBD on physiologic and subjective symptoms of alcohol withdrawal, (2) determine the capacity of CBD to improve insomnia and disordered sleep during withdrawal, and (3) determine if CBD can attenuate alcohol cravings during acute abstinence.
Results from this study can help inform the possible use of CBD as a novel adjunct treatment for alcohol withdrawal and cravings that may reduce benzodiazepine need for alcohol withdrawal treatment. If CBD is shown to be effective, this line of work also points to the potential of the endogenous cannabinoid system playing a mechanistic role in alcohol's withdrawal symptoms. Finally, this study could provide further insights into the efficacy of CBD as a sleep agent for participants with alcohol withdrawal and lay the groundwork for subsequent studies exploring CBD's use in the treatment of alcohol withdrawal in an outpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 mg/kg CBD | Active comparator | Drug: Cannabidiol (CBD)low dose CBD |
| 20 mg/kg CBD | Active comparator | Drug: Cannabidiol (CBD)high dose CBD |
| placebo | Placebo comparator | Drug: PlaceboPlacebo (no CBD) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 required medications to manage symptoms.
- 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.
- if female of childbearing potential who has not had a sterilization procedure:
Key exclusion criteria (31 listed)
- 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)
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 |
|---|---|---|
| Cannabidiol (CBD)Cannabidiol | Drug | 10 mg/kg CBD, 20 mg/kg CBD |
| Placeboplacebo | Drug | placebo |
Primary outcome
Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)
Time frame: Four times daily during inpatient stay (4 nights)
The Alcohol Withdrawal Symptom Checklist (AWSC) is a validated measure in which participants report their own withdrawal symptoms. The scale consists of 17 items. The total possible score is 0-68, with higher scores indicating more severe withdrawal symptoms. The highest score for a participant across the duration of their time on the Clinical Research Unit (CRU) will be included in the analysis.
Peak score on the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)
Time frame: 4 times daily during inpatient stay (4 nights)
The Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) is a clinically administered measurement that represents the gold standard for assessing the severity of withdrawal symptoms. It consists of 10-items: nausea/ vomiting, tremor, paroxysmal sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation/clouding of sensorium. Each sign and symptom is rated on a Likert scale from 0-7 (with 0=absent and 7 =most severe), except for "clouding of sensorium," which is ranked from 0 to 4. Scores on the CIWA-Ar scale range from 0 to 67, with higher scores indicating more severe withdrawal. The highest score for a participant across the duration of their time on the CRU will be included in the analysis. Clinical staff will use these scores to justify administration of benzodiazepines to treat withdrawal symptoms.
Average total sleep time (minutes) and wake after sleep onset as measured by wrist actigraphy
Time frame: 4 nights during inpatient stay
Actigraphy will provide a primary assessment of sleep outcomes including total sleep time and wake after sleep onset. The actigraphy devices used will be triaxial accelerometers from Generation model 9 (GT9X) Link Wrist Actigraphy, Actigraph LLC. Values for total sleep time and wake time after sleep onset will be averaged across the study's four nights; this average will be included in the analysis.
Peak alcohol craving as measured by scores on the Alcohol Urge Questionnaire (AUQ)
Time frame: Four times daily during inpatient stay (4 nights)
The Alcohol Urge Questionnaire (AUQ) is an eight-item self-report questionnaire that has demonstrated validity and discriminative value in identifying and measuring alcohol craving. Each item is ranked on a score of 0 to 7, with a maximum score range of 0- 56. Higher scores indicate greater craving. The highest score for a participant across the duration of their time on the CRU will be included in the analysis.
8 secondary outcomes
Average Total Sleep Time (minutes) as reported in Consensus Sleep Diary (CSD) results
Time frame: Upon waking each morning during inpatient stay (4 days)
Total Amount of Time (minutes) on Awakenings, as reported in Consensus Sleep Diary (CSD) results
Time frame: Upon waking each morning during inpatient stay (4 days)
Sleep Quality as reported in Consensus Sleep Diary (CSD) results
Time frame: Upon waking each morning during inpatient stay (4 days)
Sleep Latency (minutes) as reported in Consensus Sleep Diary (CSD) results
Time frame: Upon waking each morning during inpatient stay (4 days)
Number of Awakenings as reported in Consensus Sleep Diary (CSD) results
Time frame: Upon waking each morning during inpatient stay (4 days)
Total amount of time (minutes) spent awake after sleep onset as reported in Consensus Sleep Diary (CSD) results
Time frame: Upon waking each morning during inpatient stay (4 days)
Total doses of lorazepam administered
Time frame: Every 4 hours during inpatient stay (4 nights)
Serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: Morning prior to admission, morning of discharge (day 5)
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
David Woliinsky, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabidiol (CBD) in people with Alcohol Use Disorder (AUD) and Withdrawal From Addictive Substance; Detoxification, run by Johns Hopkins University at 1 site in United States.
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 9 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 David Woliinsky, MD ((410) 550-0047, dwolins2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC) (time frame: Four times daily during inpatient stay (4 nights)). The study lists 4 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 3 Nov 2026.