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Alcohol Use DisorderPhase 2NCT07681869

Effects of Nimodipine on Alcohol Drinking

A Phase 2 study testing Nimodipine in people with Alcohol Use Disorder, run by Yale University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Read more about this study

Who is it for?
Ages 21 to 50 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Nimodipine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 30 Jun 2032
Phase
Phase 2
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).
  • Ability to read English at 6th grade level or higher.
  • Meet DSM-V criteria for at least moderate AUD.
  • Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the alcohol drinking paradigm (ADP).

Who cannot join

  • Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.
  • Meet current DSM-V criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.
  • Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines, and barbiturates.
  • Psychotic or other severe psychiatric disorders as determined by clinical evaluation.
  • Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.
  • Medical conditions that would contraindicate the consumption of alcohol or use of nimodipine including untreated or not adequately controlled hypertension or hypotension. Blood pressure at or below 100/65 will be exclusionary.
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  • Heart rate of less than 50 bpm.
  • Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) >3 times upper limit of normal (ULN); alanine aminotransferase (ALT) > 3 times ULN; total bilirubin >1.5 times ULN; serum creatinine >2.0 times ULN.
  • Concurrent use of the following medications: CYP3A4 inhibitors and inducers, other calcium channel blockers, or other blood pressure lowering medications.
  • Neurological trauma or disease, delirium, or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and PI, may put the patient at risk because of participation in the study.
  • Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.
  • Women who are pregnant or nursing.
  • Participants who refuse to use a reliable method of birth control from the time of first medication administration to 7 days after. These include oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm/spermicidal or condom/spermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring, surgical sterilization, or true abstinence.
  • Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.
  • Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.
  • Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.
  • Subjects who have donated blood within the past 6 weeks.
  • Heart rate of less than 50 bpm.
  • Subjects with a history or presence of cirrhosis.
  • MRI contraindications including incompatible implants, other metal in body (e.g. pacemakers, shrapnel, metal implants) or claustrophobia.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Liss contact

2034447545

thomas.liss@yale.edu

Nicholas Franco contact

2039745759

nicholas.franco@yale.edu

United States1 site

  • Yale University School of Medicine (Connecticut Mental Health Center)

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: A Randomized Controlled Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers

This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Participants will stay overnight and receive nimodipine (90 mg/dose) or placebo every six hours during an 18-hour period prior to each ADP. MEG and/or EEG data will be collected before the first dose and after the third dose of nimodipine (NIM) or placebo (PLA). Adverse events will be closely monitored during this period. During the ADP participants will receive a priming dose of alcohol followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour they will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours). ADP outcomes will include number of drinks consumed, alcohol craving, mood changes and alcohol effects, physiological measures (heart rate, blood pressure), as well as breath alcohol levels. Investigators anticipate having to recruit up to 40 participants to achieve 20 completers.

Read the detailed description

Participants with AUD who drink heavily, will participate in a double-blind, placebo-controlled, cross-over design. At baseline, eligible participants will complete an MRI scan at the Yale MR center and MEG/EEG at the VA MIND Center. ADP Lab sessions will be conducted in the CNRU at the Connecticut Mental Health Center.

Nimodipine is rapidly absorbed after oral administration \& peak concentrations are achieved within 0.5 to 1.5 hours. However, due to high first-pass metabolism, initial elimination is rapid (equivalent to a half-life of 1-2 hours); consequently, the bioavailability of nimodipine is approximately 13% after oral administration and there is a need for frequent dosing. The terminal elimination half-life of nimodipine is approximately 8 to 9 hours. In order to ensure adequate exposure and CNS bioavailability investigators will follow the administration schedule used in the Krupitsky trial*1. In this study 26 alcohol-dependent patients (who had not consumed alcohol for a month) received treatment with 90 mg dose of nimodipine (in the schedule portrayed below) prior to ketamine administration; results suggest that this dose of nimodipine reduced ketamine-induced psychosis, negative symptoms, euphoria and sedation as well as the perceived similarity of ketamine effects to alcohol. While the Krupitsky trial*1 did not report any adverse events following exposure to this dose investigators will closely monitor blood pressure and adverse events during the treatment period prior to the ADP 1 (vitals monitored at time of each dosing and again 30 minutes, 1 hour, and 2 hours after each dose).

Participants will receive either NIM or PLA in random order, during two sessions, separated by 3-5 washout days (to allow flexibility in scheduling). NIM/PLA will be provided at a dose of 90 mg/every 6 hours, over an 18-hour period (4 doses totaling 360mg), with the last dose administered approx. 1-2 hours prior to the start of the ADP period at 12 pm. MEG/EEG will be obtained 1-2 hours after the 3rd dose of NIM/PLA. During the two ADP sessions, participants will receive a priming dose of alcohol followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour they will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours). ADP outcomes will include number of drinks consumed, alcohol craving, mood changes and alcohol effects, physiological measures (heart rate, blood pressure), as well as blood alcohol levels.

Participants will have 2 follow-up visits at 1-week and 1-month after the ADP session.

Being tested
Nimodipine, Placebo
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NimodipineDrug

    Nimodipine 90mg/dose or matching placebo will be administered every 6 hours for the duration of 18 hours (approx 6pm, 12am, 6am, 12pm). In total, participants will receive a total of 4 doses totaling to 360mg.

  • PlaceboDrug

    Matching placebo will be administered on the same schedule as Nimodipine, every 6 hours for the duration of 18 hours (approx 6pm, 12am, 6am, 12pm).

Study groups in NCT07681869
Study groupRoleWhat they receive
Nimodipine 1st / Placebo 2ndExperimentalParticipants randomized to the Nimodipine 1st Arm will be administered Nimodipine prior to their 1st ADP session. Then after a washout period, participants will take a matching placebo prior to the 2nd lab session.
Receives: Drug: Nimodipine; Drug: Placebo
Placebo 1st / Nimodipine 2ndExperimentalParticipants randomized to the Placebo1st Arm will be administered matching placebo prior to their 1st ADP session. Then after a washout period, participants will be administered Nimodipine prior to the 2nd lab session.
Receives: Drug: Nimodipine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of drinks consumed

    Total number of drinks (out of 12) that were consumed during each of the two alcohol drinking paradigm (ADP) session.

    Measured: ADP Lab Session 1 (Day 1) and ADP Lab Session 2 (3-5 days later)

  2. Alcohol Craving using Yale Craving Scale

    Stimulation effect collected using the Biphasic Alcohol Effect Scale. Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on an 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation.

    Measured: ADP Lab Session 1 (Day 1) and ADP Lab Session 2 (3-5 days later)

  3. Stimulation Effect

    Stimulation effect collected using the Biphasic Alcohol Effect Scale. Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on an 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation.

    Measured: ADP Lab Session 1 (Day 1) and ADP Lab Session 2 (3-5 days later)

  4. Sedation Effect

    Stimulation effect collected using the Biphasic Alcohol Effect Scale. Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher sedation.

    Measured: ADP Lab Session 1 (Day 1) and ADP Lab Session 2 (3-5 days later)

Secondary outcomes (3)

  1. Change in Systolic Blood Pressure

    Mean change in systolic blood pressure in mmHg

    Measured: Medication dosing/ADP Lab Session 1 (Day 1) and medication dosing/ADP Lab Session 2 (3-5 days later)

  2. Change in Diastolic Blood Pressure

    Mean change in diastolic blood pressure in mmHg

    Measured: Medication dosing/ADP Lab Session 1 (Day 1) and medication dosing/ADP Lab Session 2 (3-5 days later)

  3. Change in Heart Rate

    Mean change in heart rate measured in beats per minute

    Measured: Medication dosing/ADP Lab Session 1 (Day 1) and medication dosing/ADP Lab Session 2 (3-5 days later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Jun 2032 (estimated)
  4. Study completion30 Jun 2032 (estimated)

Resources

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will receive NIM or PLA in random order, during two sessions, separated by a washout period.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681869
Sponsor's protocol ID
2000038566_a
Other IDs
2P50AA012870-21
Status last verified
Mar 2026
First submitted
25 Mar 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data will be shared.

Publications

  • Krupitsky EM, Burakov AM, Romanova TN, Grinenko NI, Grinenko AY, Fletcher J, Petrakis IL, Krystal JH. Attenuation of ketamine effects by nimodipine pretreatment in recovering ethanol dependent men: psychopharmacologic implications of the interaction of NMDA and L-type calcium channel antagonists. Neuropsychopharmacology. 2001 Dec;25(6):936-47. doi: 10.1016/S0893-133X(01)00346-3.

    PubMed 11750186

  • Donoghue T, Haller M, Peterson EJ, Varma P, Sebastian P, Gao R, Noto T, Lara AH, Wallis JD, Knight RT, Shestyuk A, Voytek B. Parameterizing neural power spectra into periodic and aperiodic components. Nat Neurosci. 2020 Dec;23(12):1655-1665. doi: 10.1038/s41593-020-00744-x. Epub 2020 Nov 23.

    PubMed 33230329

  • Freeman WJ, Holmes MD, Burke BC, Vanhatalo S. Spatial spectra of scalp EEG and EMG from awake humans. Clin Neurophysiol. 2003 Jun;114(6):1053-68. doi: 10.1016/s1388-2457(03)00045-2.

    PubMed 12804674

  • Freeman WJ, Rogers LJ, Holmes MD, Silbergeld DL. Spatial spectral analysis of human electrocorticograms including the alpha and gamma bands. J Neurosci Methods. 2000 Feb 15;95(2):111-21. doi: 10.1016/s0165-0270(99)00160-0.

    PubMed 10752481

  • Chowdhury RA, Zerouali Y, Hedrich T, Heers M, Kobayashi E, Lina JM, Grova C. MEG-EEG Information Fusion and Electromagnetic Source Imaging: From Theory to Clinical Application in Epilepsy. Brain Topogr. 2015 Nov;28(6):785-812. doi: 10.1007/s10548-015-0437-3. Epub 2015 May 28.

    PubMed 26016950

  • Chowdhury RA, Pellegrino G, Aydin U, Lina JM, Dubeau F, Kobayashi E, Grova C. Reproducibility of EEG-MEG fusion source analysis of interictal spikes: Relevance in presurgical evaluation of epilepsy. Hum Brain Mapp. 2018 Feb;39(2):880-901. doi: 10.1002/hbm.23889. Epub 2017 Nov 21.

    PubMed 29164737

  • Cortes-Briones J, Skosnik PD, Mathalon D, Cahill J, Pittman B, Williams A, Sewell RA, Ranganathan M, Roach B, Ford J, D'Souza DC. Delta9-THC Disrupts Gamma (gamma)-Band Neural Oscillations in Humans. Neuropsychopharmacology. 2015 Aug;40(9):2124-34. doi: 10.1038/npp.2015.53. Epub 2015 Apr 24.

    PubMed 25709097

  • De Clercq W, Vergult A, Vanrumste B, Van Paesschen W, Van Huffel S. Canonical correlation analysis applied to remove muscle artifacts from the electroencephalogram. IEEE Trans Biomed Eng. 2006 Dec;53(12 Pt 1):2583-7. doi: 10.1109/TBME.2006.879459.

    PubMed 17153216

  • De Vos M, Ries S, Vanderperren K, Vanrumste B, Alario FX, Van Huffel S, Burle B. Removal of muscle artifacts from EEG recordings of spoken language production. Neuroinformatics. 2010 Jun;8(2):135-50. doi: 10.1007/s12021-010-9071-0.

    PubMed 20480401

  • Tadel F, Baillet S, Mosher JC, Pantazis D, Leahy RM. Brainstorm: a user-friendly application for MEG/EEG analysis. Comput Intell Neurosci. 2011;2011:879716. doi: 10.1155/2011/879716. Epub 2011 Apr 13.

    PubMed 21584256

  • Gao R, Penzes P. Common mechanisms of excitatory and inhibitory imbalance in schizophrenia and autism spectrum disorders. Curr Mol Med. 2015;15(2):146-67. doi: 10.2174/1566524015666150303003028.

    PubMed 25732149

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimodipine in people with Alcohol Use Disorder, run by Yale 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 4 inclusion and 20 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: opening soon, as of the sponsor's last update on 2 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 Thomas Liss (2034447545, thomas.liss@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of drinks consumed (time frame: ADP Lab Session 1 (Day 1) and ADP Lab Session 2 (3-5 days later)). 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?

On the ClinicalTrials.gov record for NCT07681869, which also lists 11 linked publications.

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 2 Jul 2026.

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