20 Participants Needed

Propranolol for Alcohol Use Disorders

SC
PC
Overseen ByPaula Cunningham
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Yale University
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Propranolol has been studied for various conditions, and common side effects include drowsiness, fatigue, and dizziness, which are generally mild. In studies, the incidence of side effects was similar to placebo, indicating it is generally safe for human use.12345

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?

Research suggests that propranolol, a drug that affects the body's stress response, may help reduce alcohol consumption in animal studies. Additionally, propranolol has been shown to calm symptoms in people with alcohol withdrawal, indicating potential benefits for alcohol use disorders.12489

Who Is on the Research Team?

SM

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

I can take pills and will follow the medication plan.
I am between 21 and 65 years old.
Able to read and write English
See 1 more

Exclusion Criteria

Suicidal, homicidal, or evidence of current mental illness
Subjects likely to exhibit clinically significant alcohol withdrawal during the study
I am not pregnant, nursing, and I use approved birth control methods.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Titration

Participants titrate to steady state medication levels over a 2-week period

2 weeks
Daily medication administration

Laboratory Sessions

Participants complete two laboratory sessions with stress or neutral/relaxing state induction followed by a 2-hour alcohol self-administration paradigm

1 week
2 laboratory visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Propranolol
Trial Overview The study tests if Propranolol (a beta blocker) at a dose of 160mg/day can reduce stress-induced alcohol consumption compared to a placebo. Participants will undergo two lab sessions after a two-week period of taking the drug to see how it affects their drinking behavior under induced stress versus a relaxed state.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PropranololExperimental Treatment1 Intervention
Propranolol extended release (160mg/day). Administered orally once daily at 10:00PM. Titration schedule Days 1-3 60mg, Days 4-7 80mg, Days 8-11 120mg, and Days 12-14 160mg until steady state.
Group II: PlaceboPlacebo Group1 Intervention
Administered orally once daily at 10:00PM

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Published Research Related to This Trial

In a study involving 51 patients, both long-acting formulations of propranolol significantly reduced the frequency of migraine attacks compared to placebo, demonstrating their efficacy in migraine management.
The higher dose formulation (Inderal LA 160 mg) was more effective than the lower dose (Half-Inderal LA 80 mg) in reducing migraine frequency, with no significant difference in side effects between the two formulations.
Long-acting propranolol in the prophylaxis of migraine: a comparative study of two doses.Carroll, JD., Reidy, M., Savundra, PA., et al.[2017]
In a study using male Wistar rats, the β1/2 adrenergic receptor antagonist propranolol significantly reduced alcohol drinking, particularly showing a trend towards greater impact on compulsion-like alcohol drinking (CLAD) compared to alcohol-only drinking (AOD).
While propranolol and betaxolol showed potential in decreasing alcohol consumption, they may also cause undesirable side effects, and their effects on specific brain areas related to drinking did not yield expected results, suggesting a complex role of the noradrenergic system in alcohol use disorders.
The role of beta- and alpha-adrenergic receptors on alcohol drinking.De Oliveira Sergio, T., Wean, S., Katner, SN., et al.[2023]
In patients undergoing withdrawal from chronic alcoholism, propranolol effectively normalizes increased cardiac output and reduces peripheral vascular resistance, leading to a calming effect, as observed in a double-blind study.
Propranolol was found to be more effective than diazepam in alleviating symptoms of psychic tension associated with alcohol withdrawal, with minimal side effects reported.
Propranolol in the treatment of alchoholism: a review.Carlsson, C.[2013]

Citations

Long-acting propranolol in the prophylaxis of migraine: a comparative study of two doses. [2017]
The role of beta- and alpha-adrenergic receptors on alcohol drinking. [2023]
Propranolol in the treatment of alchoholism: a review. [2013]
Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. [2013]
Comparative efficacy of propranolol, chlordiazepoxide, and placebo in the treatment of anxiety: a double-blind trial. [2022]
Pharmacokinetic and pharmacodynamic studies with a new controlled-release formulation of propranolol in normal volunteers: a comparison with other commercially available formulations. [2019]
Propranolol in chronic anxiety disorders. A controlled study. [2022]
Stability of propranolol hydrochloride in SyrSpend SF. [2022]
Long-acting propranolol (Inderal LA): pharmacokinetics, pharmacodynamics and therapeutic use. [2019]
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