Alcohol Use DisorderPhase 2NCT06900998
Pilot Study: 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.
Trial summary
This is an open label trial aiming to recruit 5 non-treatment seeking adults with Alcohol Use Disorder. All will participate in an alcohol drinking paradigm (ADP) lab session at the Hospital Research Unit (HRU) at Yale-New Haven Hospital (YNHH). 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale University School of Medicine (Connecticut Mental Health Center)
New Haven, Connecticut, 06519
Thomas Liss, 2034447545, thomas.liss@yale.edu
Suchitra Krishnan-Sarin, PhD
About this study
Official title: A Pilot Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers
This is an open label trial aiming to recruit 5 non-treatment seeking adults with Alcohol Use Disorder. All will participate in an alcohol drinking paradigm (ADP) lab session at the Hospital Research Unit (HRU) at Yale-New Haven Hospital (YNHH). Participants will stay overnight and receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP to allow for the limited central nervous system bioavailability of this drug. Electroencephalogram (EEG) data will be collected before the first dose and after the last dose of nimodipine. Adverse events will be closely monitored during this period. During the ADP session 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, participants will be able to choose between drinking up to four drinks or receive the monetary equivalents of these drinks (total of 12 drinks over three hours).
Read the detailed description
This is an open label trial. Five adults, 21-50 years of age, with Alcohol Use Disorder, who are not looking for treatment for their drinking behaviors, and who consume at least 30-70 standard drinks for men or 25-65 standard drinks for women per week will be recruited. Participants will be screened for eligibility including a full physical exam. All will participate in an alcohol drinking paradigm (ADP) lab session at Yale New Haven Hospital's Hospital Research Unit (HRU). Participants will receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP session while admitted to the HRU overnight. Additionally, electroencephalography (EEG) data will be collected while at the HRU. 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, the administration schedule used will be similar to that used in the Krupitsky trial. 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 over 18 hours) 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 did not report any adverse events following exposure to this dose, blood pressure and adverse events will be closely monitored during the treatment period prior to the ADP (monitored at time of each dosing and again 30 minutes, 1 hour, and 2 hours after each dose). During the ADP session, participants will receive a priming dose of alcohol at 1:00pm followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour participants will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours).
After the ADP, participants will be given dinner, and breath alcohol levels will be assessed until 10pm. If at 10pm, a participant has a breath alcohol level less than .03, they will be discharged; if greater than .03 but less than .05, a nurse on the clinical unit will evaluate to ensure the participant is alert and oriented and has no visible signs of intoxication (slurred speech, unsteady gait). If cleared by the nurse, instructions will be given to not drive or operate heavy machinery for the rest of the night. If not cleared, the nurse will continue to monitor until clearance is given. All participants will then be discharged and provided an Uber ride home.
Participants will have 2 follow-up visits 1-week and 1-month after the ADP session.
- Conditions
- Alcohol Use Disorder
- Being tested
- Nimodipine
- 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 will be administered orally beginning on the evening prior to the study lab session. 90mg doses will be administered at 6:00pm, 12:00am, 6:00am, and 12:00pm.
| Study group | Role | What they receive |
|---|---|---|
| Nimodipine | Experimental | All participants will be assigned to this arm and will receive study drug (nimodipine), open label. Receives: Drug: Nimodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinks consumed
Total number of drinks (out of 12) that were consumed during the alcohol drinking paradigm (ADP) session.
Measured: Lab Session 1 (Day 1)
Alcohol Craving using Yale Craving Scale
Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving.
Measured: Lab Session 1 (Day 1)
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: Lab Session 1 (Day 1)
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: Lab Session 1 (Day 1)
Secondary outcomes (3)
Change in Systolic Blood Pressure
Mean change in systolic blood pressure in mmHg
Measured: Lab Session 1 (Days 0 and 1)
Change in Diastolic Blood Pressure
Mean change in diatolic blood pressure in mmHg
Measured: Lab Session 1 (Days 0 and 1)
Change in Heart Rate
Mean change in heart rate measured in beats per minute
Measured: Lab Session 1 (Days 0 and 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Suchitra Krishnan-Sarin, Yale University
- Investigators
- Suchitra Krishnan-Sarin, Principal investigator, Yale University School of Medicine, Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900998
- Sponsor's protocol ID
- 2000038566
- Other IDs
- 2P50AA012870-21
- Status last verified
- Oct 2025
- First submitted
- 21 Mar 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study done to inform procedures for a larger clinical trial. There are no plans to share IPD at this time.
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers
- ClinicalTrials.gov ID
- NCT06900998
- Acronym / sponsor ID
- 2000038566
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label trial aiming to recruit 5 non-treatment seeking adults with Alcohol Use Disorder. All will participate in an alcohol drinking paradigm (ADP) lab session at the Hospital Research Unit (HRU) at Yale-New Haven Hospital (YNHH). Participants will stay overnight and receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP to allow for the limited central nervous system bioavailability of this drug. Electroencephalogram (EEG) data will be collected before the first dose and after the last dose of nimodipine. Adverse events will be closely monitored during this period. During the ADP session 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, participants will be able to choose between drinking up to four drinks or receive the monetary equivalents of these drinks (total of 12 drinks over three hours).
Detailed description
This is an open label trial. Five adults, 21-50 years of age, with Alcohol Use Disorder, who are not looking for treatment for their drinking behaviors, and who consume at least 30-70 standard drinks for men or 25-65 standard drinks for women per week will be recruited. Participants will be screened for eligibility including a full physical exam. All will participate in an alcohol drinking paradigm (ADP) lab session at Yale New Haven Hospital's Hospital Research Unit (HRU). Participants will receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP session while admitted to the HRU overnight. Additionally, electroencephalography (EEG) data will be collected while at the HRU. 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, the administration schedule used will be similar to that used in the Krupitsky trial. 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 over 18 hours) 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 did not report any adverse events following exposure to this dose, blood pressure and adverse events will be closely monitored during the treatment period prior to the ADP (monitored at time of each dosing and again 30 minutes, 1 hour, and 2 hours after each dose). During the ADP session, participants will receive a priming dose of alcohol at 1:00pm followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour participants will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours).
After the ADP, participants will be given dinner, and breath alcohol levels will be assessed until 10pm. If at 10pm, a participant has a breath alcohol level less than .03, they will be discharged; if greater than .03 but less than .05, a nurse on the clinical unit will evaluate to ensure the participant is alert and oriented and has no visible signs of intoxication (slurred speech, unsteady gait). If cleared by the nurse, instructions will be given to not drive or operate heavy machinery for the rest of the night. If not cleared, the nurse will continue to monitor until clearance is given. All participants will then be discharged and provided an Uber ride home.
Participants will have 2 follow-up visits 1-week and 1-month after the ADP session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimodipine | Experimental | Drug: NimodipineAll participants will be assigned to this arm and will receive study drug (nimodipine), open label. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimodipineNimodipine will be administered orally beginning on the evening prior to the study lab session. 90mg doses will be administered at 6:00pm, 12:00am, 6:00am, and 12:00pm. | Drug | Nimodipine |
Primary outcome
Number of drinks consumed
Time frame: Lab Session 1 (Day 1)
Total number of drinks (out of 12) that were consumed during the alcohol drinking paradigm (ADP) session.
Alcohol Craving using Yale Craving Scale
Time frame: Lab Session 1 (Day 1)
Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving.
Stimulation Effect
Time frame: Lab Session 1 (Day 1)
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.
Sedation Effect
Time frame: Lab Session 1 (Day 1)
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.
3 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Lab Session 1 (Days 0 and 1)
Change in Diastolic Blood Pressure
Time frame: Lab Session 1 (Days 0 and 1)
Change in Heart Rate
Time frame: Lab Session 1 (Days 0 and 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 11750186Krupitsky 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.
- Individual participant dataSharing planned: No. This is a pilot study done to inform procedures for a larger clinical trial. There are no plans to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suchitra Krishnan-Sarin principal investigator
Yale University School of Medicine, Dept of Psychiatry
1 site in 1 country: see every site and its status.
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 19 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 17 Mar 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: Lab Session 1 (Day 1)). 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 NCT06900998, which also lists 1 linked publication.
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 17 Mar 2026.