Alcohol WithdrawalPhase 1/2NCT07810946
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
A Phase 1/2 study testing Sodium Acetate in people with Alcohol Withdrawal and Alcohol Abstinence, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Alcohol withdrawal syndrome is a highly morbid condition affecting a substantial percentage of patients hospitalized who have alcohol use disorders, estimated at 5-6% of all hospitalized patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Withdrawal, Alcohol Abstinence, Alcohol Use Disorder
- What is being tested?
- Sodium Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Jun 2029
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active treatment for alcohol withdrawal (e.g. use of protocolized order set in an inpatient setting)
- Inpatient admission ordered
- Adult > 21 years old
Who cannot join
- End-stage renal disease or likely need for renal replacement therapy in the next 12 hours
- Heart failure with reduced ejection fraction (<30%)
- Receipt of >2L crystalloids prior to randomization
- Advanced liver disease (Child's C or D)
- Uncontrolled mental health condition
- >24 hours since ED arrival
- Pregnant or incarcerated
- Unable to consent and/or no proxy
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
University of Colorado, Anshcutz Medical Campus
Aurora, Colorado, 80045
Jeffrey McKeehan, AC-AGNP, 303-724-6080, jeffrey.mckeehan@cuanschutz.edu
About this study
Alcohol withdrawal syndrome is a highly morbid condition affecting a substantial percentage of patients hospitalized who have alcohol use disorders, estimated at 5-6% of all hospitalized patients. Standard treatment paradigms for alcohol withdrawal syndrome have common and serious side effects, and do not fully address this condition's underlying pathophysiology.
This study will examine the feasibility and safety of administering intravenous acetate, an alcohol metabolite and alternative brain fuel, as an adjunctive treatment for alcohol withdrawal in hospitalized patients that will to set the stage for future investigations of its efficacy as an adjunctive treatment in the hospital setting.
Read the detailed description
Alcohol withdrawal syndrome manifests in up to 30% of hospitalized patients with severe alcohol use disorders (AUD), and is a potentially life-threatening, highly morbid condition. Standard medications to treat alcohol withdrawal (e.g. benzodiazepines) can induce respiratory depression and prolong hospitalization, while medications used as adjuncts (e.g. dexmedetomidine) are also sedating and necessitate intensive monitoring. Therefore, alternative treatments targeting novel pathways in alcohol withdrawal are needed to address this treatment gap and improve patient care. Although alcohol withdrawal symptoms arise from counterregulatory neuroadaptations in γ-aminobutyric acid (GABA) and glutamate signaling, homeostatic alterations in the brain's fuel preference and sudden changes in its fuel supply have also been implicated that are not addressed by current treatment paradigms. Longstanding AUD diminishes the brain's ability to metabolize glucose, enhancing its metabolic preference for the alcohol metabolite acetate. Acetate is converted to acetyl-CoA, which is used for fuel and neurotransmitter production. When a person with AUD is hospitalized, stopping alcohol consumption, acetate supply ceases at a time when the brain has a reduced preference for glucose, potentially driving withdrawal symptoms. Investigations in patients with alcohol withdrawal that administered alternative energy substrates via oral ketogenic diet (which also generates acetyl-CoA) reported symptom improvement; however, prominent gastrointestinal symptoms in acute, severe alcohol withdrawal limit their use in this setting. Notably, we have shown that intravenous (IV) acetate administration to participants with AUD was feasible and safe and had a demonstrable physiological effect on cerebral blood flow (CBF), measured by magnetic resonance arterial spin labeling, including increased CBF to thalami, cerebellum, and cortex, which was not observed in healthy controls. Since metabolism and blood flow are tightly linked in the brain, our results support metabolic adaptations in AUD, paving the way for future investigations of acetate's efficacy as an adjunctive treatment in alcohol withdrawal that will be refined in this R34 proposal. We will conduct a single- center, placebo-controlled randomized clinical trial (RCT) of IV acetate in patients hospitalized at a large academic university hospital who are receiving inpatient standard of care treatment for alcohol withdrawal syndrome.
Aim 1 will optimize screening, recruitment, informed consent, and enrollment strategies. Aim 2 will establish processes to ensure protocol fidelity, safety, and patient retention, to include collection of outcome variables reflecting patient symptoms and medication administration for alcohol withdrawal, and healthcare resource utilization. Aim 3 will use qualitative methods to incorporate the experiences and perceptions of patients hospitalized with alcohol withdrawal to improve study design and magnify the impact of the research.
Results of this study will inform the final protocol and procedures for a future multi-center RCT focused on determining efficacy of adjunctive acetate treatment in patients admitted for alcohol withdrawal syndrome.
- Conditions
- Alcohol Withdrawal, Alcohol Abstinence, Alcohol Use Disorder
- Being tested
- Sodium Acetate, Placebo
- Keywords
- Alcohol Withdrawal
- Medical subject headings
- Alcohol Abstinence, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium AcetateDrug
Sodium acetate (82mg/mEq) will be mixed in solution with sterile water to create a 150 mEq/L (same as 150 mM) isotonic solution. Patients randomized to active drug will initially receive 300 mM (mEq) acetate in 2L fluid over a two-hour period. The study drug will be administered as an initial 6 mg/kg/min bolus (~250mL volume) over 10 min, followed by a 3 mg/kg/min infusion (1750ml volume) over 110 min to complete 2L total. After the two hours are completed, patients will continue to receive the acetate solution infusion at a reduced rate of 50 mL/hour (or 615 mg acetate/ hour) until alcohol withdrawal orders are discontinued, or up to 72 hours, whichever comes first.
PlaceboDrug
Also called normal saline
The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (IV acetate) | Experimental | Sodium acetate (82mg/mEq) will be mixed in solution with sterile water to create a 150 mEq/L (same as 150 mM) isotonic solution. Patients randomized to active drug will initially receive 300 mM (mEq) acetate in 2L fluid over a two-hour period. The study drug will be administered as an initial 6 mg/kg/min bolus (~250mL volume) over 10 min, followed by a 3 mg/kg/min infusion (1750ml volume) over 110 min to complete 2L total. After the two hours are completed, patients will continue to receive the acetate solution infusion at a reduced rate of 50 mL/hour (or 615 mg acetate/ hour) until alcohol withdrawal orders are discontinued, or up to 72 hours, whichever comes first. Receives: Drug: Sodium Acetate |
| Placebo (normal saline) | Placebo comparator | The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate for Study Participation per Week
Number and percentage of patients meeting all study eligibility criteria who provide informed consent for study participation among all eligible patients identified during each week of recruitment.
Measured: Assessed weekly during the study recruitment period, pre-consent
Proportion of Randomized Participants Receiving Greater Than or Equal to 2 L of Assigned Study Infusion
Number and percentage of randomized participants who receive at least 2 L of their assigned study infusion (study drug or placebo), as a measure of study protocol fidelity.
Measured: After consent and randomization, immediately before study infusion, through completion or discontinuation of the study infusion, up to 72 hours.
Proportion of Randomized Participants Withdrawn from Study for Safety Concerns
Number and percentage of randomized participants for whom study participation or study intervention is discontinued because of a safety concern.
Measured: After consent, immediately before study infusion, through completion, withdraw or discontinuation of the study infusion during the index hospitalization, up to 72 hours.
Alcohol Withdrawal Medications Administered, per Patient
Alcohol withdrawal medication utilization will be characterized descriptively for each participant by the total dose administered and total number of treatment days. Medications will be summarized by prespecified treatment category: (1) GABAergic medications, including benzodiazepines and phenobarbital, and (2) adjunctive medications, including dexmedetomidine and ketamine. Individual medications and medication classes will be reported separately, as applicable.
Measured: After consent and randomization, through hospital discharge from the index hospitalization or study completion at 18 months, what occurs first.
Secondary outcomes (12)
Screening Volume
Number of emergency department patients with an alcohol withdrawal pathway or order set initiated per week. Screening opportunities will also be characterized according to day of the week and time of day when the pathway or order set is initiated.
Measured: Pre-consent. Assessed weekly during the study recruitment period
Eligibility Rate
Number and percentage of screened patients meeting all inclusion criteria and no exclusion criteria and therefore eligible to be approached for informed consent.
Measured: Pre-consent. Assessed weekly during the study recruitment period
Characteristics of Patients Who Do and Do Not Consent
Characteristics of eligible patients who do and do not consent to study participation will be summarized descriptively, including age, gender, race, ethnicity, English versus Spanish language, comorbid conditions, availability of a proxy, and whether consent was provided by a proxy.
Measured: Pre-consent through completion of the consent/enrollment attempt during the index hospitalization
Time to Informed Consent
Time from documented emergency department arrival to documentation of informed consent, determined using electronic medical record date and time stamps.
Measured: Pre-consent. From emergency department arrival through documentation of informed consent
Study Drug Receipt, per Patient
Receipt of the assigned study intervention (either drug or placebo) will be characterized by total study drug dose received, total infusion volume received, total duration of infusion, and time between randomization and initiation of the study drug infusion.
Measured: After consent and randomization. Assessed through completion or discontinuation of the study infusion, for up to 72 hours.
Reasons for Study Withdrawal
Reasons for study withdrawal will be characterized, with particular assessment of withdrawal related to acid-base and/or electrolyte abnormalities, and respiratory-related instability.
Measured: After randomization through study completion, withdrawal, or hospital discharge, for up to 72 hours.
Thiamine Dosing
Total thiamine administration will be characterized descriptively based on the total dose received per randomized participant.
Measured: At baseline, after hospital arrival, through hospital discharge or study conclusion, for up to 18 months, whichever occurs first.
Modified Minnesota Detoxification Scale (mMINDS) Scores Over Time
Serial mMINDS scores recorded by nurses will be used to characterize the severity and trajectory of alcohol withdrawal symptoms during the course of the hospitalization.
Measured: At baseline, after hospital arrival, through hospital discharge or study conclusion, for up to 18 months, whichever occurs first.
Requirement for Mechanical Ventilation
Determined by wheter the patient required mechanical ventilation or not, for any reason.
Measured: At baseline, after hospital arrival, through hospital discharge or study conclusion, for up to 18 months, whichever occurs first.
In-hospital Mortality
Number and percentage of participants who die during the index hospitalization and number and percentage who are discharged against medical advice. Each outcome will be reported separately.
Measured: After consent and randomization, through discharge from the index hospitalization or study consluion, for up to 18 months, whichever occurs first.
Upgrade in Level of Care
Level of care will be recorded by whether or not the patient required transfer to higher level of care, for example if the patient was on a medical ward but was transferred to an Intensive Care Unit.
Measured: After consent and randomization, thourgh the patient's hospital admission period or study conclusion, for up to 18 months, whichever occurs first.
Duration and Intensity of Alcohol Withdrawal Monitoring
Alcohol withdrawal monitoring will be characterized by the total duration that the alcohol withdrawal order set remains active and the total number of nursing alcohol withdrawal assessments, including mMINDS assessments, completed for each participant.
Measured: After hospital arrival through hospital discharge, or study conclusion, for up to 18 months, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ellen Burnham, MD, Principal investigator, University of Colorado, Department of Pulmonary, Allergy and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810946
- Sponsor's protocol ID
- 26-1125
- Other IDs
- 1R34AA033528-01
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT07810946
- Acronym / sponsor ID
- 26-1125
- Conditions
- Alcohol Withdrawal, Alcohol Abstinence, Alcohol Use Disorder
- Keywords
- Alcohol Withdrawal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Sep 2026 (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.
Alcohol withdrawal syndrome is a highly morbid condition affecting a substantial percentage of patients hospitalized who have alcohol use disorders, estimated at 5-6% of all hospitalized patients. Standard treatment paradigms for alcohol withdrawal syndrome have common and serious side effects, and do not fully address this condition's underlying pathophysiology.
This study will examine the feasibility and safety of administering intravenous acetate, an alcohol metabolite and alternative brain fuel, as an adjunctive treatment for alcohol withdrawal in hospitalized patients that will to set the stage for future investigations of its efficacy as an adjunctive treatment in the hospital setting.
Detailed description
Alcohol withdrawal syndrome manifests in up to 30% of hospitalized patients with severe alcohol use disorders (AUD), and is a potentially life-threatening, highly morbid condition. Standard medications to treat alcohol withdrawal (e.g. benzodiazepines) can induce respiratory depression and prolong hospitalization, while medications used as adjuncts (e.g. dexmedetomidine) are also sedating and necessitate intensive monitoring. Therefore, alternative treatments targeting novel pathways in alcohol withdrawal are needed to address this treatment gap and improve patient care. Although alcohol withdrawal symptoms arise from counterregulatory neuroadaptations in γ-aminobutyric acid (GABA) and glutamate signaling, homeostatic alterations in the brain's fuel preference and sudden changes in its fuel supply have also been implicated that are not addressed by current treatment paradigms. Longstanding AUD diminishes the brain's ability to metabolize glucose, enhancing its metabolic preference for the alcohol metabolite acetate. Acetate is converted to acetyl-CoA, which is used for fuel and neurotransmitter production. When a person with AUD is hospitalized, stopping alcohol consumption, acetate supply ceases at a time when the brain has a reduced preference for glucose, potentially driving withdrawal symptoms. Investigations in patients with alcohol withdrawal that administered alternative energy substrates via oral ketogenic diet (which also generates acetyl-CoA) reported symptom improvement; however, prominent gastrointestinal symptoms in acute, severe alcohol withdrawal limit their use in this setting. Notably, we have shown that intravenous (IV) acetate administration to participants with AUD was feasible and safe and had a demonstrable physiological effect on cerebral blood flow (CBF), measured by magnetic resonance arterial spin labeling, including increased CBF to thalami, cerebellum, and cortex, which was not observed in healthy controls. Since metabolism and blood flow are tightly linked in the brain, our results support metabolic adaptations in AUD, paving the way for future investigations of acetate's efficacy as an adjunctive treatment in alcohol withdrawal that will be refined in this R34 proposal. We will conduct a single- center, placebo-controlled randomized clinical trial (RCT) of IV acetate in patients hospitalized at a large academic university hospital who are receiving inpatient standard of care treatment for alcohol withdrawal syndrome.
Aim 1 will optimize screening, recruitment, informed consent, and enrollment strategies. Aim 2 will establish processes to ensure protocol fidelity, safety, and patient retention, to include collection of outcome variables reflecting patient symptoms and medication administration for alcohol withdrawal, and healthcare resource utilization. Aim 3 will use qualitative methods to incorporate the experiences and perceptions of patients hospitalized with alcohol withdrawal to improve study design and magnify the impact of the research.
Results of this study will inform the final protocol and procedures for a future multi-center RCT focused on determining efficacy of adjunctive acetate treatment in patients admitted for alcohol withdrawal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (IV acetate) | Experimental | Drug: Sodium AcetateSodium acetate (82mg/mEq) will be mixed in solution with sterile water to create a 150 mEq/L (same as 150 mM) isotonic solution. Patients randomized to active drug will initially receive 300 mM (mEq) acetate in 2L fluid over a two-hour period. The study drug will be administered as an initial 6 mg/kg/min bolus (~250mL volume) over 10 min, followed by a 3 mg/kg/min infusion (1750ml volume) over 110 min to complete 2L total. After the two hours are completed, patients will continue to receive the acetate solution infusion at a reduced rate of 50 mL/hour (or 615 mg acetate/ hour) until alcohol withdrawal orders are discontinued, or up to 72 hours, whichever comes first. |
| Placebo (normal saline) | Placebo comparator | Drug: PlaceboThe placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active treatment for alcohol withdrawal (e.g. use of protocolized order set in an inpatient setting)
- Inpatient admission ordered
- Adult > 21 years old
Key exclusion criteria (8 listed)
- End-stage renal disease or likely need for renal replacement therapy in the next 12 hours
- Heart failure with reduced ejection fraction (<30%)
- Receipt of >2L crystalloids prior to randomization
- Advanced liver disease (Child's C or D)
- Uncontrolled mental health condition
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 |
|---|---|---|
| Sodium AcetateSodium acetate (82mg/mEq) will be mixed in solution with sterile water to create a 150 mEq/L (same as 150 mM) isotonic solution. Patients randomized to active drug will initially receive 300 mM (mEq) acetate in 2L fluid over a two-hour period. The study drug will be administered as an initial 6 mg/kg/min bolus (~250mL volume) over 10 min, followed by a 3 mg/kg/min infusion (1750ml volume) over 110 min to complete 2L total. After the two hours are completed, patients will continue to receive the acetate solution infusion at a reduced rate of 50 mL/hour (or 615 mg acetate/ hour) until alcohol withdrawal orders are discontinued, or up to 72 hours, whichever comes first. | Drug | Intervention (IV acetate) |
| PlaceboAlso: normal salineThe placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate. | Drug | Placebo (normal saline) |
Primary outcome
Consent Rate for Study Participation per Week
Time frame: Assessed weekly during the study recruitment period, pre-consent
Number and percentage of patients meeting all study eligibility criteria who provide informed consent for study participation among all eligible patients identified during each week of recruitment.
Proportion of Randomized Participants Receiving Greater Than or Equal to 2 L of Assigned Study Infusion
Time frame: After consent and randomization, immediately before study infusion, through completion or discontinuation of the study infusion, up to 72 hours.
Number and percentage of randomized participants who receive at least 2 L of their assigned study infusion (study drug or placebo), as a measure of study protocol fidelity.
Proportion of Randomized Participants Withdrawn from Study for Safety Concerns
Time frame: After consent, immediately before study infusion, through completion, withdraw or discontinuation of the study infusion during the index hospitalization, up to 72 hours.
Number and percentage of randomized participants for whom study participation or study intervention is discontinued because of a safety concern.
Alcohol Withdrawal Medications Administered, per Patient
Time frame: After consent and randomization, through hospital discharge from the index hospitalization or study completion at 18 months, what occurs first.
Alcohol withdrawal medication utilization will be characterized descriptively for each participant by the total dose administered and total number of treatment days. Medications will be summarized by prespecified treatment category: (1) GABAergic medications, including benzodiazepines and phenobarbital, and (2) adjunctive medications, including dexmedetomidine and ketamine. Individual medications and medication classes will be reported separately, as applicable.
12 secondary outcomes
Screening Volume
Time frame: Pre-consent. Assessed weekly during the study recruitment period
Eligibility Rate
Time frame: Pre-consent. Assessed weekly during the study recruitment period
Characteristics of Patients Who Do and Do Not Consent
Time frame: Pre-consent through completion of the consent/enrollment attempt during the index hospitalization
Time to Informed Consent
Time frame: Pre-consent. From emergency department arrival through documentation of informed consent
Study Drug Receipt, per Patient
Time frame: After consent and randomization. Assessed through completion or discontinuation of the study infusion, for up to 72 hours.
Reasons for Study Withdrawal
Time frame: After randomization through study completion, withdrawal, or hospital discharge, for up to 72 hours.
Thiamine Dosing
Time frame: At baseline, after hospital arrival, through hospital discharge or study conclusion, for up to 18 months, whichever occurs first.
Modified Minnesota Detoxification Scale (mMINDS) Scores Over Time
Time frame: At baseline, after hospital arrival, through hospital discharge or study conclusion, for up to 18 months, whichever occurs first.
Requirement for Mechanical Ventilation
Time frame: At baseline, after hospital arrival, through hospital discharge or study conclusion, for up to 18 months, whichever occurs first.
In-hospital Mortality
Time frame: After consent and randomization, through discharge from the index hospitalization or study consluion, for up to 18 months, whichever occurs first.
Upgrade in Level of Care
Time frame: After consent and randomization, thourgh the patient's hospital admission period or study conclusion, for up to 18 months, whichever occurs first.
Duration and Intensity of Alcohol Withdrawal Monitoring
Time frame: After hospital arrival through hospital discharge, or study conclusion, for up to 18 months, whichever occurs first.
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 30 Oct 2026.
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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.
Ellen Burnham, MD principal investigator
University of Colorado, Department of Pulmonary, Allergy and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sodium Acetate in people with Alcohol Withdrawal and Alcohol Abstinence, run by University of Colorado, Denver 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 3 inclusion and 8 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 30 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jeffrey McKeehan, AC-AGNP (303-724-6080, jeffrey.mckeehan@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent Rate for Study Participation per Week (time frame: Assessed weekly during the study recruitment period, pre-consent). 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?
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 30 Oct 2026.