Nimodipine for Alcoholism

Overseen By Nicholas Franco

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: CYP3A4 inhibitors, Calcium channel blockers

Disqualifiers: Substance use disorder, Hypertension, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called nimodipine to determine its effectiveness for Alcohol Use Disorder (AUD). Researchers aim to understand how nimodipine affects the brain and drinking behavior through a combination of alcohol and monitoring sessions. The study seeks adults who drink heavily but are not currently seeking treatment for their drinking. Participants should have a history of frequent drinking and not be undergoing treatment for other substance use disorders. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically CYP3A4 inhibitors and inducers, other calcium channel blockers, or other blood pressure lowering medications. If you are on a stable dose of an antidepressant for at least 2 months, you may continue taking it.

Is there any evidence suggesting that nimodipine is likely to be safe for humans?

Research has shown that nimodipine is generally well tolerated. In one study, 26 participants who had abstained from alcohol for a month took nimodipine every six hours and reported no side effects. Another study on alcohol withdrawal reported similar findings—nimodipine was well tolerated, with no side effects noted. While these studies suggest nimodipine is safe, individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Nimodipine is unique in the treatment of alcoholism because it targets calcium channels in the brain, which is a different approach compared to most existing treatments that focus on neurotransmitter systems like GABA or dopamine. This mechanism could potentially help in stabilizing mood and reducing cravings associated with alcohol withdrawal. Researchers are excited about nimodipine because it offers a novel pathway to manage alcoholism, potentially providing relief for those who haven't responded well to traditional medications.

What evidence suggests that nimodipine might be an effective treatment for alcoholism?

Research suggests that nimodipine, which all participants in this trial will receive, may help with symptoms of alcohol withdrawal, particularly by improving nervous system and mental health symptoms. Studies have shown that it can reduce anxiety and depression in people with alcoholism. Nimodipine might also help lessen the urge to drink. In one study, patients who had not consumed alcohol for a month received nimodipine and showed improvements. Overall, while nimodipine seems promising, more research is needed to fully understand its effectiveness in treating alcoholism. ^{1 2 3 4 6}

Who Is on the Research Team?

Suchitra Krishnan-Sarin

Principal Investigator

Yale University School of Medicine, Dept of Psychiatry

Are You a Good Fit for This Trial?

This trial is for non-treatment seeking adults aged 21-50 with Alcohol Use Disorder who can read English at a 6th grade level or higher. Participants must drink an average of 30-70 drinks per week for men and 20-65 for women, but not be currently seeking alcohol treatment or have been in treatment within the last six months.

Inclusion Criteria

Ability to read English at 6th grade level or higher

Meet DSM-V criteria for at least moderate AUD

I am between 21 and 50 years old.

Exclusion Criteria

Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines, and barbiturates

I do not like drinking spirits.

Subjects who have donated blood within the past 6 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP session, with EEG data collection and monitoring for adverse events.

1 day

Overnight stay (in-person)

Alcohol Drinking Paradigm (ADP) Session

Participants receive a priming dose of alcohol followed by a one-hour monitoring period, then three one-hour self-administration periods where they can choose between drinks or monetary equivalents.

1 day

1 session (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ADP session with follow-up visits.

1 month

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nimodipine

Trial Overview

The study tests Nimodipine's effects on alcohol consumption by having participants stay overnight at Yale-New Haven Hospital, take doses of Nimodipine every six hours before an alcohol drinking session, and choose between drinking alcohol or receiving money during self-administration periods.

How Is the Trial Designed?

Group I: Nimodipine Experimental Treatment 1 Intervention

All participants will be assigned to this arm and will receive study drug (nimodipine), open label.

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06900998

NCT06900998 | Effects of Nimodipine on Alcohol Drinking

In that study 26 alcohol-dependent patients (who had not consumed alcohol for a month) received treatment with 90 mg dose of nimodipine every 6 hours (4 doses ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/2136211/

Nimodipine in human alcohol withdrawal syndrome

A statistically significant improvement of AWS was seen at evaluation on day 3, particularly in neurovegetative and psychopathological symptoms, and lasted up ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/0022395692900037

Nimodipine in acute alcohol withdrawal state

The effect of the calcium channel blocker, nimodipine, in acute alcohol withdrawal was investigated in a randomized, placebo controlled, double blind study.

4.

withpower.com

withpower.com/trial/phase-2-alcoholism-3-2025-5928b

Nimodipine for Alcoholism · Info for Participants

Some studies suggest that nimodipine may help reduce anxiety and depression in people with alcoholism, and it might also decrease the urge to drink during ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1613678/

Nimodipine in acute alcohol withdrawal state

Thus, no significant effect of nimodipine on the acute alcohol withdrawal state could be demonstrated. There was some tendency for nimodipine to ameliorate ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06900998?term=AREA%5BBasicSearch%5D(nimodipine)&rank=9

NCT06900998 | Effects of Nimodipine on Alcohol Drinking

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...