Alcohol Use DisorderPhase 2NCT05661669
Ketamine for the Treatment for Alcohol Use Disorder in the ED
A Phase 2 study testing Ketamine and Saline in people with Alcohol Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators' approach is to conduct a pilot double-blind, placebo-controlled randomized clinical trial with individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED) to receive either intravenous ketamine or saline placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Ketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 19 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking adults aged 18 and above
- Diagnosed with DSM5 alcohol use disorder, severe
- Admitted to BWF inpatient withdrawal management unit (Addiction Recovery Program)
Who cannot join
- Any psychotic disorder, bipolar disorder, active suicidality or homicidality
- Inability to perform consent due to impaired mental status
- Clinical Institute Withdrawal Assessment (CIWA) score > 20 at any point in the ED
- Alcohol withdrawal seizure prior to or during the ED visit
- Systolic blood pressure persistently elevated above 180mmHg, or heart rate >130bmp, in the ED
- History of hypersensitivity to ketamine, or experience of emergence reaction
Show all 13Show fewer
- History of any illicit or recreational use of ketamine
- Receipt of ketamine treatment for depression in the past 3 months
- History of DSM5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, renal failure, obstructive lung disease, or sleep apnea
- History within 6 months of head trauma, stroke, or myocardial infarction
- Liver dysfunction with LFTs >3x upper normal limit
- Current use of medications with known drug-drug interactions with ketamine (i.e., St. John's Wort, theophylline, opioid analgesics, CNS depressants other than benzodiazepines or phenobarbital)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
Official title: Ketamine for the Treatment for Alcohol Use Disorder in the Emergency Department: A Pilot Double-blind, Placebo-controlled Randomized Clinical Trial
The investigators' approach is to conduct a pilot double-blind, placebo-controlled randomized clinical trial with individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED) to receive either intravenous ketamine or saline placebo. The primary aim is to evaluate the intervention's safety. The secondary aim is to evaluate the preliminary efficacy of alcohol-related outcomes.
Read the detailed description
This is a pilot double-blind, placebo-controlled randomized clinical trial of 50 individuals with alcohol use disorder (AUD) presenting to the emergency department (ED) seeking inpatient detoxification to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The study will be conducted at Brigham and Women's Faulkner Hospital (BWF), an urban, 171-bed hospital located in Boston, MA, and a major teaching hospital for Harvard Medical School (HMS). Participants will be randomized in a double-blind fashion to receive either ketamine or saline placebo in the ED. All participants will receive the institution's standard treatment, which includes detoxification, intensive psychosocial support, and referral to outpatient treatment. The intervention (ketamine) will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes, and the placebo will be a 0.9% saline solution also administered over 40 minutes. To determine the safety of administering ketamine the investigators will measure the incidence of severe adverse events (AE), defined as either hypertensive urgency (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg) or tachycardia (heart rate>130bpm). The investigators will also assess side effects, alcohol withdrawal, and craving for alcohol and ketamine. To determine the preliminary efficacy of ketamine on alcohol-related outcomes, the investigators will measure the proportion of abstinent days during the follow-up assessed using Timeline Follow-Back (TLFB). The investigators will also measure days to relapse, the proportion of heavy drinking days, engagement with addiction treatment, urine ketamine, and alcohol biomarkers (urine ethylglucuronide and serum phosphatidylethanol) at 28-days. The investigators hypothesize that results will show adequate safety and that those receiving ketamine, compared to placebo, will not experience more side effects, worse withdrawal, or greater alcohol or ketamine craving. The investigators also hypothesize that those receiving ketamine will report better drinking outcomes compared to placebo.
- Conditions
- Alcohol Use Disorder
- Being tested
- Ketamine, Saline
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
The intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes.
SalineDrug
The placebo will be a 0.9% saline solution administered over 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | This arm will receive ketamine (n=25) Receives: Drug: Ketamine |
| Placebo | Placebo comparator | This arm will receive the saline placebo (n=25) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administering ketamine in the emergency department (ED) for alcohol use disorder (AUD) patients seeking detoxification
The incidence of severe adverse events (AE), defined as either hypertensive urgency (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg) or tachycardia (heart rate>130bpm). Adequate safety will be defined as <10% of participants experiencing severe AEs.
Measured: Outcomes will be assessed throughout the inpatient admission, on average 3-5 days and throughout duration of study.
Secondary outcomes (18)
Dissociative effects
Clinician-Administered Dissociative States Scale (CADSS)
Measured: Baseline, daily during inpatient (average 3-5 days), 28 days, and 3, 6, and 12 months after inpatient treatment.
Alcohol withdrawal
Clinical Institute Withdrawal Assessment (CIWA)
Measured: Assessed during the inpatient admission, on average 3-5 days.
Craving for alcohol
Alcohol craving questionnaire
Measured: Assessed during the inpatient admission, on average 3-5 days; 7, 14, 28 days and 3, 6, and 12 months after treatment
Craving for ketamine
Visual analog scale
Measured: Assessed during the inpatient admission, on average 3-5 days; 7, 14, 28 days and 3, 6, and 12 months after treatment
Cue-induced craving
Visual analog scale will be used to rate the craving following a standardized protocol used to assess cue reactivity. The cue exposure procedure will end with a standardized relaxation exercise.
Measured: Assessed during the inpatient admission, on average 3-5 days; 28 days after treatment
Preliminary efficacy of ketamine on days to alcohol relapse
Days to relapse will be measured by using the Timeline Follow-Back (TLFB).
Measured: 7, 14, 28 days and 3, 6, and 12 months after treatment
Preliminary efficacy of ketamine on proportion heavy drinking days
The proportion of heavy drinking days will be measured by using the Timeline Follow-Back (TLFB).
Measured: 7, 14, 28 days and 3, 6, and 12 months after treatment
Preliminary efficacy of ketamine on engagement with addiction treatment
The Alcoholic Anonymous Affiliation Scale (AAAS) will be used to measure engagement with addiction treatment. This is a 9-item scale to measure the degree of involvement with Alcoholics Anonymous.
Measured: Measured at baseline, 28 days, and 3, 6, and 12 months post treatment.
Ketamine in Urine
Urine drug screen that includes ketamine will be assessed.
Measured: At baseline and 28 days after treatment
Urine ethylglucuronide
Urine ethylglucuronide (EtG) will be obtained
Measured: At baseline and at 28 days after treatment
Phosphatidylethanol (PEth)
Serum phosphatidylethanol (PEth)
Measured: At baseline and at 28 days after treatment
Behavior Change Mechanisms
Mechanisms of behavior change will be measured using tools from the Science of Behavior Change Measures.
Measured: Once during inpatient treatment and at 28 days after treatment
Anxiety
We will assess anxiety levels utilizing a 7-item scale (Generalized Anxiety Disorder - 7 (GAD-7))
Measured: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Depression
We will assess depression levels utilizing a 9-item scale (Patient Health Questionnaire-9 (PHQ-9))
Measured: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Suicidal Ideation
Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal Ideation
Measured: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Post Traumatic Stress
A patient self-report tool developed to examine PTSD symptoms in general medical settings (Abbreviated PTSD Checklist - Civilian Version)
Measured: Once during treatment
Study Drug Side Effects
We will use Patient Rated Inventory of Side Effects (PRISE) to qualify side effects in the following domains: gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms which can be endorsed. For each domain the patient rates whether the symptoms are tolerable or distressing.
Measured: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Spirituality
We will use a 23-item measure to assess spirituality (Spirituality Scale).
Measured: Baseline, once during treatment, and at 28 days post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Sep 2023
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Why it stopped: After months of screening, we screened 175 individuals, only 3 were eligible, 2 declined, and 1 was moved to a different floor before study activities were able to take place.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661669
- Sponsor's protocol ID
- 2022P002550
- Other IDs
- 1R21AA030372-01A1
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine for the Treatment for Alcohol Use Disorder in the Emergency Department: A Pilot Double-blind, Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05661669
- Acronym / sponsor ID
- 2022P002550
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After months of screening, we screened 175 individuals, only 3 were eligible, 2 declined, and 1 was moved to a different floor before study activities were able to take place.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 22 Dec 2022 (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.
The investigators' approach is to conduct a pilot double-blind, placebo-controlled randomized clinical trial with individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED) to receive either intravenous ketamine or saline placebo. The primary aim is to evaluate the intervention's safety. The secondary aim is to evaluate the preliminary efficacy of alcohol-related outcomes.
Detailed description
This is a pilot double-blind, placebo-controlled randomized clinical trial of 50 individuals with alcohol use disorder (AUD) presenting to the emergency department (ED) seeking inpatient detoxification to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The study will be conducted at Brigham and Women's Faulkner Hospital (BWF), an urban, 171-bed hospital located in Boston, MA, and a major teaching hospital for Harvard Medical School (HMS). Participants will be randomized in a double-blind fashion to receive either ketamine or saline placebo in the ED. All participants will receive the institution's standard treatment, which includes detoxification, intensive psychosocial support, and referral to outpatient treatment. The intervention (ketamine) will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes, and the placebo will be a 0.9% saline solution also administered over 40 minutes. To determine the safety of administering ketamine the investigators will measure the incidence of severe adverse events (AE), defined as either hypertensive urgency (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg) or tachycardia (heart rate>130bpm). The investigators will also assess side effects, alcohol withdrawal, and craving for alcohol and ketamine. To determine the preliminary efficacy of ketamine on alcohol-related outcomes, the investigators will measure the proportion of abstinent days during the follow-up assessed using Timeline Follow-Back (TLFB). The investigators will also measure days to relapse, the proportion of heavy drinking days, engagement with addiction treatment, urine ketamine, and alcohol biomarkers (urine ethylglucuronide and serum phosphatidylethanol) at 28-days. The investigators hypothesize that results will show adequate safety and that those receiving ketamine, compared to placebo, will not experience more side effects, worse withdrawal, or greater alcohol or ketamine craving. The investigators also hypothesize that those receiving ketamine will report better drinking outcomes compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineThis arm will receive ketamine (n=25) |
| Placebo | Placebo comparator | Drug: SalineThis arm will receive the saline placebo (n=25) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking adults aged 18 and above
- Diagnosed with DSM5 alcohol use disorder, severe
- Admitted to BWF inpatient withdrawal management unit (Addiction Recovery Program)
Key exclusion criteria (13 listed)
- Any psychotic disorder, bipolar disorder, active suicidality or homicidality
- Inability to perform consent due to impaired mental status
- Clinical Institute Withdrawal Assessment (CIWA) score > 20 at any point in the ED
- Alcohol withdrawal seizure prior to or during the ED visit
- Systolic blood pressure persistently elevated above 180mmHg, or heart rate >130bmp, in the ED
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 |
|---|---|---|
| KetamineThe intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes. | Drug | Ketamine |
| SalineThe placebo will be a 0.9% saline solution administered over 40 minutes. | Drug | Placebo |
Primary outcome
Safety of administering ketamine in the emergency department (ED) for alcohol use disorder (AUD) patients seeking detoxification
Time frame: Outcomes will be assessed throughout the inpatient admission, on average 3-5 days and throughout duration of study.
The incidence of severe adverse events (AE), defined as either hypertensive urgency (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg) or tachycardia (heart rate>130bpm). Adequate safety will be defined as <10% of participants experiencing severe AEs.
18 secondary outcomes
Dissociative effects
Time frame: Baseline, daily during inpatient (average 3-5 days), 28 days, and 3, 6, and 12 months after inpatient treatment.
Alcohol withdrawal
Time frame: Assessed during the inpatient admission, on average 3-5 days.
Craving for alcohol
Time frame: Assessed during the inpatient admission, on average 3-5 days; 7, 14, 28 days and 3, 6, and 12 months after treatment
Craving for ketamine
Time frame: Assessed during the inpatient admission, on average 3-5 days; 7, 14, 28 days and 3, 6, and 12 months after treatment
Cue-induced craving
Time frame: Assessed during the inpatient admission, on average 3-5 days; 28 days after treatment
Preliminary efficacy of ketamine on days to alcohol relapse
Time frame: 7, 14, 28 days and 3, 6, and 12 months after treatment
Preliminary efficacy of ketamine on proportion heavy drinking days
Time frame: 7, 14, 28 days and 3, 6, and 12 months after treatment
Preliminary efficacy of ketamine on engagement with addiction treatment
Time frame: Measured at baseline, 28 days, and 3, 6, and 12 months post treatment.
Ketamine in Urine
Time frame: At baseline and 28 days after treatment
Urine ethylglucuronide
Time frame: At baseline and at 28 days after treatment
Phosphatidylethanol (PEth)
Time frame: At baseline and at 28 days after treatment
Behavior Change Mechanisms
Time frame: Once during inpatient treatment and at 28 days after treatment
Anxiety
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Depression
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Suicidal Ideation
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Post Traumatic Stress
Time frame: Once during treatment
Study Drug Side Effects
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Spirituality
Time frame: Baseline, once during treatment, and at 28 days post treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ketamine and Saline in people with Alcohol Use Disorder, run by Brigham and Women's Hospital 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 13 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: withdrawn, as of the sponsor's last update on 8 Jan 2025. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of administering ketamine in the emergency department (ED) for alcohol use disorder (AUD) patients seeking detoxification (time frame: Outcomes will be assessed throughout the inpatient admission, on average 3-5 days and throughout duration of study.). 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 8 Jan 2025.