Propranolol for Alcohol Use Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to take oral medications and adhere to the medication regimen for the trial.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for propranolol in treating alcohol use disorders?
The safety data for propranolol, under various formulations like Inderal and Inderal LA, has been evaluated in studies for conditions such as migraine and anxiety. Common side effects include drowsiness, fatigue, dizziness, and indigestion, which were generally mild. In a study comparing propranolol with chlordiazepoxide and placebo for anxiety, the incidence of side effects was similar between propranolol and chlordiazepoxide, with some side effects more frequent in each group compared to placebo. No significant differences in pharmacokinetic and pharmacodynamic parameters were observed among different brands of propranolol. These studies suggest that propranolol is generally well-tolerated, but specific safety data for alcohol use disorders is not directly available from the provided studies.12345
Is propranolol generally safe for humans?
Is propranolol a promising drug for alcohol use disorders?
Propranolol is a drug that has shown promise in treating various conditions like migraines, high blood pressure, and heart issues. It is available in different forms and brands, and studies suggest it can be effective in managing symptoms over a long period. However, there is no specific information in the provided research about its effectiveness for alcohol use disorders.13467
How does the drug propranolol differ from other treatments for alcohol use disorders?
Propranolol is unique because it is a beta blocker, typically used for heart-related conditions, that may help with alcohol use disorders by reducing anxiety and stress, which are often triggers for alcohol consumption. Its long-acting formulation allows for once-daily dosing, which can improve patient convenience and adherence compared to treatments requiring multiple doses per day.13467
What data supports the idea that Propranolol for Alcohol Use Disorders is an effective drug?
The available research shows that propranolol may help with symptoms related to alcohol use disorders. In one study, propranolol was found to calm patients during the withdrawal phase of chronic alcoholism, and it was more effective than diazepam in reducing symptoms of psychic tension. Another study on rats indicated that higher doses of propranolol reduced alcohol drinking. However, the research is limited, and propranolol's effectiveness compared to other treatments for alcohol use disorders is not well-established.12489
What data supports the effectiveness of the drug propranolol for alcohol use disorders?
Who Is on the Research Team?
Sherry McKee, PhD
Principal Investigator
Professor
Are You a Good Fit for This Trial?
This trial is for adults aged 21-65 who have been diagnosed with alcohol use disorders in the last 6 months, can read and write English, and are willing to take oral medication regularly. It's not suitable for those at risk of severe alcohol withdrawal, with serious health issues, pregnant or nursing women not using effective birth control, or individuals with recent mental illness.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Titration
Participants titrate to steady state medication levels over a 2-week period
Laboratory Sessions
Participants complete two laboratory sessions with stress or neutral/relaxing state induction followed by a 2-hour alcohol self-administration paradigm
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Propranolol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator