Alcohol Use DisorderKMENCT03878225
Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans?
A study testing H.V.M.N. Ketone Ester in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Anders Fink-Jensen, MD, DMSci at 2 sites in Denmark.
Trial summary
A ketogenic diet (KD) is high in fat and low in carbohydrates and induces ketosis. KD is an approved non-pharmacological therapy for drug-resistant child epilepsy. Research has shown that a KD can reduce the behavioral measures of alcohol withdrawal symptomatology in rats. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal, Ketosis
- What is being tested?
- H.V.M.N. Ketone Ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Jun 2020to 31 Mar 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years of age.
- Ability to provide written informed consent as determined by the physical examination and verbal communication. The capacity to consent will be determined by study personnel.
- Alcohol-dependent individuals must meet alcohol dependency syndrome criteria according to ICD-10 and alcohol use disorder according to DSM-5, have a score >15 on the Alcohol Use Disorder Identification Test (AUDIT) and a history of previous treatment for alcohol withdrawal syndrome following cessation of alcohol use.
- Between 18 and 70 years of age.
- Ability to provide written informed consent as determined by the physical examination and verbal communication. The capacity to consent will be determined by study personnel.
- Light drinkers (LD): Alcohol consumption less than 7 drinks per week typically over the past year and no more than three drinks per occasion. AUDIT score below 7 in the Alcohol Use Disorder Identification Test.
- Heavy drinkers (HD): Not treatment-seeking and not fulfilling criteria for alcohol dependence syndrome according to ICD-10 or alcohol use disorder according to DSM-5. For at least one-year consuming alcohol at a typical rate of above a level of 14 drinks per week for men and consume at least 4 drinks per day at least once per week. For females, consume alcohol in excess of 11 drinks per week and exceed 3 drinks per day at least once per week.
- Long term sober (LTS): For the long-term sober group, a previous diagnosis of alcohol dependence, consumed no alcohol in the previous 6 months.
Who cannot join
- Diagnosis of current psychiatric disorder that is deemed not stable by the study physician, except for the following:
- Diagnosis of nicotine dependence
- Alcohol withdrawal patients may have a diagnosis of alcohol dependence
- HD may have a diagnosis of alcohol abuse
- Lifetime diagnosis of bipolar disorder, schizophrenia, paranoid psychosis or mental retardation.
- Incapable of understanding and/or speaking Danish.
Show all 25Show fewer
- Head trauma with loss of consciousness for more than 60 minutes (self-report, medical history).
- Lifetime diagnosis of epilepsy.
- Alcohol withdrawal seizures within the previous 3 months.
- Use of any medication that could interfere with study assessments, including anticonvulsants, benzodiazepines and non-benzodiazepine hypnotics (Zopiclone and/or Zolpidem). Use of medications will be reviewed by a study physician on a case by case basis.
- Body Mass Index, BMI, < 18.5 kg/m2 or body weight <60 kg or >120kg.
- Urine positive for cocaine, amphetamines, methadone, opioids or benzodiazepines.
- Blood glucose >12.2 mmol/L on finger-prick measurement (>7.0 if over-night fasted).
- Known kidney disease, pancreatic disease, porphyria or other mitochondrial diseases, type 1 diabetes, type 2 diabetes or any other history of severe somatic illness that the investigator believes would interfere with trial participation.
- Known cirrhosis or clinical evidence of significant liver disease, such as ascites or hepatosplenomegaly.
- Following a low-carbohydrate diet, intermittent fasting diet or consuming nutritional ketone supplements.
- Other substance use dependency than alcohol and/or nicotine and/or cannabis within the previous 1 month.
- Benzodiazepine dependence within the previous 1 month and/or use of benzodiazepines within the previous 14 days.
- Females of childbearing potential who are pregnant, breast-feeding or have intention of becoming pregnant within the next 4 months, or are not using contraceptives (during the whole study period) considered as highly effective (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device - IUD, IUS, bilateral tubal occlusion, vasectomized partner, sexual abstinence) (HMA - Clinical Trials Facilitation and Coordination Group, 2014).
- Participated in a clinical trial with investigational medication or weight reduction within the previous three months.
- Use of Disulfiram (Antabus) in the previous 14 days prior to any planned KME ingestion or MRS procedure.
- For HD and LD groups in MRS sub-study only: Inability to abstain from alcohol for 24 hours, to reduce risks and to avoid confounding results with alcohol withdrawal.
- For HD and LD in MRS sub-study only: History of alcohol use disorder or alcohol withdrawal symptoms requiring medication
- For participants undergoing MRS (all HD, LD, and LTS, some KME patients): Implanted metallic devices or objects that could potentially prove harmful when exposed to the MRS environment or procedures. Patients in the alcohol withdrawal group can still participate in the KME study if meeting this criterion, but cannot undergo subsequent MRS.
- Any condition that the investigator estimates would interfere with trial participation and/or the safety of the participant.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Psychiatric Center Copenhagen, Rigshospitalet
Copenhagen, 2100
Anders Fink-Jensen, Professor, Dmsc,, 0045-22755843, anders.fink-jensen@regionh.dk
Jakob Damsgaard, M. D., 0045-60852901, jakob.damsgaard.01@regionh.dk
- Recruiting
Novavi Lyngby
Lyngby, Danmark (DK), 2800
Jakob Damsgaard, MD, 0045-60852901, jakob.damsgaard.01@regionh.dk
Anders Fink-Jensen, MD, DMSc, Professor, 0045-22755843, anders.fink-jensen@regionh.dk
About this study
Official title: The Ketone Mono Ester Study - Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans
A ketogenic diet (KD) is high in fat and low in carbohydrates and induces ketosis. KD is an approved non-pharmacological therapy for drug-resistant child epilepsy. Research has shown that a KD can reduce the behavioral measures of alcohol withdrawal symptomatology in rats. Ketosis is also possible to achieve without adherence to a KD, by ingestion of a ketogenic dietary supplement. In this study, we want to investigate if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal symptoms in humans.
Objective:
Read more
To test the effect of a ketogenic dietary supplement on the need for benzodiazepines in managing alcohol withdrawal syndrome in humans.
Eligibility:
Adults 18-70 years who are alcohol dependent and are seeking treatment for alcohol withdrawal syndrome in an out-patient setting.
Design:
Double blinded, randomized clinical trial. The participants will be randomized to receive either the ketone ester beverage, or a placebo beverage.
The study will be conducted over three days (72 hours), with follow-up at 1 month and 1 year after completion. A sub-set of patients will undergo Magnetic Resonance Spectroscopy (MRS) following withdrawal treatment, and again after 1 month.
Read the detailed description
Neuroimaging studies have shown that acute alcohol administration decreases glucose metabolism in the human brain, which was initially thought to reflect decreased brain function. However, subsequent studies showed that even low doses of alcohol, with minimal behavioral effects, also decreased baseline brain glucose metabolism and further. This led to the hypothesis that the reduction in brain glucose metabolism during alcohol intoxication reflected the brain's utilization of an alternate energy substrate, e.g. the alcohol metabolite acetate. Acetate is not a ketone body, but biochemically similar to the ketone bodies, which include acetoacetate, BHB and acetone. Ketone bodies are similarly taken up by the Monocarboxylate Transporters in neurons, and other brain tissue. A pre-clinical trial has demonstrated that the implementation of a KD for 10 days significantly reduced the behavioral measures of alcohol withdrawal symptomatology in rats. In this study, we want to investigate if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal symptoms in humans.
Objectives:
We will investigate the effect of a five times daily oral administration of a ketone dietary supplement beverage vs. placebo on the need for benzodiazepines in alcohol withdrawal syndrome. The KME beverage is a supplement to standardized out-patient alcohol withdrawal treatment.
Study population:
36 participants aged 18-70 with a diagnosis of alcohol use disorder according to the DSM-V, ICD-10, and a previous history of treatment-requiring alcohol withdrawal syndrome.
Design:
Clinical double-blinded, randomized, placebo-controlled, three-day clinical trial, with an MRS (Magnetic Resonance Spectroscopy) sub-study. The participants will be randomized to receive either the ketone ester beverage, or a placebo beverage 5 times daily. Participants will be asked to register benzodiazepine use in a medication-diary during the study. Participants will be asked to self-monitor blood-glucose and ketone levels by use of fingerstick measurements. During the study patients will be evaluated for withdrawal severity, and complete questionnaires on alcohol craving, sleep, anxiety and mood.
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal, Ketosis
- Being tested
- H.V.M.N. Ketone Ester, Placebo
- Medical subject headings
- Alcoholism, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.V.M.N. Ketone EsterDietary supplement
Also called Ketone beverage, ketone mono ester (https://hvmn.com/ketone)
The ketone mono ester will be ingested 5 times daily for 3 days (72 hours). Please see above for details.
PlaceboOther
The placebo will be ingested 5 times daily for 3 days (72 hours). Please see above for details.
| Study group | Role | What they receive |
|---|---|---|
| Ketone Mono Ester | Active comparator | The ketone mono ester is commercially available dietary supplement beverage named "H.V.M.N. Ketone Ester", marketed by HVMN Inc®. The KME beverage consists of water, D-β-hydroxybutyrate ester, stevia leaf extract, natural flavors, malic acid, potassium sorbate and potassium benzoate. The active ingredient is the D-β-hydroxybutyrate ester, with each dose containing 25g. Participants will be asked to ingest this 5 times daily for 3 days (72 hours), to a total of 15 doses during the study. Receives: Dietary Supplement: H.V.M.N. Ketone Ester |
| Placebo | Placebo comparator | The placebo beverage will consist of water added with a colorless, bitter flavor enhancer and a sweetening agent (Stevia) to approximate the taste of the KME beverage as closely as possible. The bitter flavor enhancer used is denatonium benzoate (Bitrex®). The placebo beverage will be delivered to patients in bottles identical to those used in the active arm. Patients, investigators and other caregivers will be blinded to treatment allocation until time of database unlock. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benzodiazepine use
Quantity of benzodiazepine needed to manage alcohol withdrawal symptoms.
Measured: 2 years
Magnetic Resonance Spectroscopy sub-study
For the MRS sub-study brain BHB, GABA and Glutamate will be measured with 1H MRS following KME ingestion. Results will be compared with healthy volunteers with differing alcohol consumption habits.
Measured: 2 years
Secondary outcomes (6)
Sleep quality
Daily self-reported sleep quality on a VAS scale. Self-reported estimated sleep-time in previous 24 hours.
Measured: 2 years
Alcohol withdrawal symptoms.
Alcohol withdrawal symptoms assessed by use of the revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). Measures of pulse, blood pressure and respiratory frequency.
Measured: 2 years
Anxiety
Anxiety assessed with VAS questionnaires
Measured: 2 years
Alcohol craving
Alcohol craving assessed with the Desire for Alcohol Questionnaire (DAQ)
Measured: 2 years
Alcohol intake
Asses alcohol intake after the trial at one month and one year after completion, using the Timeline Follow Back method (TLFB). Assess the Alcohol Use Disorder Identification Test (AUDIT) at the beginning of the trial and one year after termination of the trial
Measured: 2 years
Mood
Mood, assessed by the Major Depression Inventory scale, MDI. The MDI is a self report mood questionnaire. Symptoms are rated based on how the patient has been feeling over the past two weeks.
The diagnostic demarcation line indicates at which point a symptom is severe enough to be used in the DSM-IV diagnostic algorithm of major depression.
Each question has a point giving system from 0-5 points. The higher the score, the more severe outcome. Scores from 20-24 indicates minor depressive symptoms. Scores from 25-29 indicates a moderate depression. Scores from 30 and above indicates major depressive symptoms.
Measured: Assess mood measured by VAS questionnaires during the trial, and by the Major Depressive Inventory (MDI) at screening and one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start15 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
- Investigators
- Anders Fink-Jensen, MD, DMSc, Principal investigator, Psychiatric Center Copenhagen, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878225
- Sponsor's protocol ID
- H-18045204
- Acronym
- KME
- Status last verified
- Jul 2020
- First submitted
- 13 Feb 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bornebusch AB, Mason GF, Tonetto S, Damsgaard J, Gjedde A, Fink-Jensen A, Thomsen M. Effects of ketogenic diet and ketone monoester supplement on acute alcohol withdrawal symptoms in male mice. Psychopharmacology (Berl). 2021 Mar;238(3):833-844. doi: 10.1007/s00213-020-05735-1. Epub 2021 Jan 7.
PubMed 33410985
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ketone Mono Ester Study - Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans
- ClinicalTrials.gov ID
- NCT03878225
- Acronym / sponsor ID
- KME / H-18045204
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal, Ketosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 18 Mar 2019 (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.
A ketogenic diet (KD) is high in fat and low in carbohydrates and induces ketosis. KD is an approved non-pharmacological therapy for drug-resistant child epilepsy. Research has shown that a KD can reduce the behavioral measures of alcohol withdrawal symptomatology in rats. Ketosis is also possible to achieve without adherence to a KD, by ingestion of a ketogenic dietary supplement. In this study, we want to investigate if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal symptoms in humans.
Objective:
To test the effect of a ketogenic dietary supplement on the need for benzodiazepines in managing alcohol withdrawal syndrome in humans.
Eligibility:
Adults 18-70 years who are alcohol dependent and are seeking treatment for alcohol withdrawal syndrome in an out-patient setting.
Design:
Double blinded, randomized clinical trial. The participants will be randomized to receive either the ketone ester beverage, or a placebo beverage.
The study will be conducted over three days (72 hours), with follow-up at 1 month and 1 year after completion. A sub-set of patients will undergo Magnetic Resonance Spectroscopy (MRS) following withdrawal treatment, and again after 1 month.
Detailed description
Neuroimaging studies have shown that acute alcohol administration decreases glucose metabolism in the human brain, which was initially thought to reflect decreased brain function. However, subsequent studies showed that even low doses of alcohol, with minimal behavioral effects, also decreased baseline brain glucose metabolism and further. This led to the hypothesis that the reduction in brain glucose metabolism during alcohol intoxication reflected the brain's utilization of an alternate energy substrate, e.g. the alcohol metabolite acetate. Acetate is not a ketone body, but biochemically similar to the ketone bodies, which include acetoacetate, BHB and acetone. Ketone bodies are similarly taken up by the Monocarboxylate Transporters in neurons, and other brain tissue. A pre-clinical trial has demonstrated that the implementation of a KD for 10 days significantly reduced the behavioral measures of alcohol withdrawal symptomatology in rats. In this study, we want to investigate if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal symptoms in humans.
Objectives:
We will investigate the effect of a five times daily oral administration of a ketone dietary supplement beverage vs. placebo on the need for benzodiazepines in alcohol withdrawal syndrome. The KME beverage is a supplement to standardized out-patient alcohol withdrawal treatment.
Study population:
36 participants aged 18-70 with a diagnosis of alcohol use disorder according to the DSM-V, ICD-10, and a previous history of treatment-requiring alcohol withdrawal syndrome.
Design:
Clinical double-blinded, randomized, placebo-controlled, three-day clinical trial, with an MRS (Magnetic Resonance Spectroscopy) sub-study. The participants will be randomized to receive either the ketone ester beverage, or a placebo beverage 5 times daily. Participants will be asked to register benzodiazepine use in a medication-diary during the study. Participants will be asked to self-monitor blood-glucose and ketone levels by use of fingerstick measurements. During the study patients will be evaluated for withdrawal severity, and complete questionnaires on alcohol craving, sleep, anxiety and mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blinded, randomized, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Ketone Mono Ester | Active comparator | Dietary Supplement: H.V.M.N. Ketone EsterThe ketone mono ester is commercially available dietary supplement beverage named "H.V.M.N. Ketone Ester", marketed by HVMN Inc®. The KME beverage consists of water, D-β-hydroxybutyrate ester, stevia leaf extract, natural flavors, malic acid, potassium sorbate and potassium benzoate. The active ingredient is the D-β-hydroxybutyrate ester, with each dose containing 25g. Participants will be asked to ingest this 5 times daily for 3 days (72 hours), to a total of 15 doses during the study. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo beverage will consist of water added with a colorless, bitter flavor enhancer and a sweetening agent (Stevia) to approximate the taste of the KME beverage as closely as possible. The bitter flavor enhancer used is denatonium benzoate (Bitrex®). The placebo beverage will be delivered to patients in bottles identical to those used in the active arm. Patients, investigators and other caregivers will be blinded to treatment allocation until time of database unlock. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between 18 and 70 years of age.
- Ability to provide written informed consent as determined by the physical examination and verbal communication. The capacity to consent will be determined by study personnel.
- Alcohol-dependent individuals must meet alcohol dependency syndrome criteria according to ICD-10 and alcohol use disorder according to DSM-5, have a score >15 on the Alcohol Use Disorder Identification Test (AUDIT) and a history of previous treatment for alcohol withdrawal syndrome following cessation of alcohol use.
- Between 18 and 70 years of age.
- Ability to provide written informed consent as determined by the physical examination and verbal communication. The capacity to consent will be determined by study personnel.
Key exclusion criteria (25 listed)
- Diagnosis of current psychiatric disorder that is deemed not stable by the study physician, except for the following:
- Lifetime diagnosis of bipolar disorder, schizophrenia, paranoid psychosis or mental retardation.
- Incapable of understanding and/or speaking Danish.
- Head trauma with loss of consciousness for more than 60 minutes (self-report, medical history).
- Lifetime diagnosis of epilepsy.
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 |
|---|---|---|
| H.V.M.N. Ketone EsterAlso: Ketone beverage, ketone mono ester (https://hvmn.com/ketone)The ketone mono ester will be ingested 5 times daily for 3 days (72 hours). Please see above for details. | Dietary supplement | Ketone Mono Ester |
| PlaceboThe placebo will be ingested 5 times daily for 3 days (72 hours). Please see above for details. | Other | Placebo |
Primary outcome
Benzodiazepine use
Time frame: 2 years
Quantity of benzodiazepine needed to manage alcohol withdrawal symptoms.
Magnetic Resonance Spectroscopy sub-study
Time frame: 2 years
For the MRS sub-study brain BHB, GABA and Glutamate will be measured with 1H MRS following KME ingestion. Results will be compared with healthy volunteers with differing alcohol consumption habits.
6 secondary outcomes
Sleep quality
Time frame: 2 years
Alcohol withdrawal symptoms.
Time frame: 2 years
Anxiety
Time frame: 2 years
Alcohol craving
Time frame: 2 years
Alcohol intake
Time frame: 2 years
Mood
Time frame: Assess mood measured by VAS questionnaires during the trial, and by the Major Depressive Inventory (MDI) at screening and one-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 33410985Bornebusch AB, Mason GF, Tonetto S, Damsgaard J, Gjedde A, Fink-Jensen A, Thomsen M. Effects of ketogenic diet and ketone monoester supplement on acute alcohol withdrawal symptoms in male mice. Psychopharmacology (Berl). 2021 Mar;238(3):833-844. doi: 10.1007/s00213-020-05735-1. Epub 2021 Jan 7.
- Individual participant dataSharing planned: No
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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.
Anders Fink-Jensen, MD, DMSc principal investigator
Psychiatric Center Copenhagen, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.V.M.N. Ketone Ester in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Anders Fink-Jensen, MD, DMSci at 2 sites in Denmark.
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 8 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Fink-Jensen, MD, DMSc (0045-22755843, Anders.Fink-Jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benzodiazepine use (time frame: 2 years). The study lists 2 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 NCT03878225, 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 7 Jul 2020.