Baltimore, MDNCT07148843Now EnrollingIRB Ready

Alcohol Use Disorder (AUD) Clinical Trial in Baltimore, MD

Access cutting-edge alcohol use disorder (aud) treatment through this phase 2/3 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Johns Hopkins University

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Expert Care in Baltimore

Access alcohol use disorder (aud) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related alcohol use disorder (aud) treatment provided free

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Check if you qualify for this alcohol use disorder (aud) clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Alcohol Use Disorder (AUD) Study in Baltimore

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.

Sponsor: Johns Hopkins University

Who Can Participate

Inclusion Criteria

Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder
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
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.

Exclusion Criteria

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
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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07148843) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alcohol Use Disorder (AUD) Treatment Options in Baltimore, MD

If you're searching for alcohol use disorder (aud) treatment options in Baltimore, MD, this clinical trial (NCT07148843) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced alcohol use disorder (aud) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alcohol use disorder (aud) clinical trials near you to find additional studies recruiting in your area.

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