Alcohol AbusePhase 2SEMALCONCT05895643
Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?
A Phase 2 study testing Semaglutide Injectable Product in people with Alcohol Abuse and Alcohol Addiction, run by Psychiatric Centre Rigshospitalet at 1 site in Denmark.
Trial summary
This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI>30 kg/m2). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Addiction, Alcohol Dependence
- What is being tested?
- Semaglutide Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jun 2023to 31 Jul 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed oral and written consent
- Diagnosed with alcohol dependence according to the criteria of the International Classification of Diseases 10 (ICD-10), and diagnosed with alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Alcohol use disorder identification test (AUDIT) score >15
- Body mass index (BMI) above or equal to 30 kg/m2
- Age 18 - 70 years (both included)
- Heavy alcohol drinking defined as more than 6 days with alcohol consumption over 4 units (48 g alcohol) for women and 5 units (60 g alcohol) for men during a consecutive 30-day period, within 40 days prior to baseline evaluation, measured by the TLFB method. The 30-day period will be the 30 consecutive days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol) out of the 40 days.
Who cannot join
- Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
- A history of delirium tremens or alcohol withdrawal seizures
- No serious withdrawal symptoms at inclusion (a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)) at baseline examinations
- Present or former neurological disease, including traumatic brain injury
- Type 1 diabetes, type 2 diabetes in poor glycaemic control (defined as HbA1c ≥48 mmol/l or fasting plasma glucose above 7.0 mmol/l at inclusion)
- Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus two months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen 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, bilateral tubal occlusion, vasectomised partner, sexual abstinence).
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- Pregnancy (serum human chorionic gonadotropin (hCG) > 3 U/L at inclusion)
- Impaired hepatic function (liver transaminases >3 times the upper limit)
- Impaired renal function (eGFR < 50 ml/min and/or plasma creatinine >150 μmol/l)
- Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase > 2 times upper limit)
- Former medullary thyroid carcinoma (MTC) and/or family history with MTC and/or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
- Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg)
- Concomitant pharmacotherapy against alcohol use disorder, i.e., disulfiram, naltrexone, acamprosate, or nalmefene, since the first of the 30 drinking days registered for inclusion at the TLFB-schedule.
- Receiving any investigational drug within the last three months
- Use of weight-lowering pharmacotherapy within the preceding 3 months
- Any other active substance use defined as a DUDIT-score >1 (except nicotine)
- Hypersensitivity to the active substance or any of the excipients
- Only for patients undergoing brain scans:
- o Contraindications for undergoing an MRI scan (magnetic implants, pacemaker, claustrophobia, etc.)
- Unable to speak and/or understand Danish
- Any condition that the investigator feels would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, 2000
About this study
Official title: Does the Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?
This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI>30 kg/m2).
Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26.
The primary endpoint is the percentage-point reduction in total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.
- Being tested
- Semaglutide Injectable Product, Placebo
- Keywords
- GLP-1, Glucagon-like peptide 1, semaglutide, fMRI, MRS
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Injectable ProductDrug
Also called Wegovy
Once weekly injections s.c with semaglutide (Wegovy)
PlaceboDrug
Also called BD Posiflush (saline)
Once weekly injections s.c with placebo (BD Posiflush)
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Experimental | Wegovy once-weekly s.c.titrated to a maximum dose of 2.4 mg Receives: Drug: Semaglutide Injectable Product |
| placebo | Placebo comparator | Saline s.c. once-weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heavy drinking days
Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)). A heavy drinking day is defined as more than 60/48 grams (men/women) of alcohol in one day, measured with the validated timeline follow-back (TLFB) method.
Measured: From baseline to 26 weeks of treatment
Secondary outcomes (25)
Change in heavy drinking days adjusted for maximum tolerable semaglutide dose given
Change in heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)) and maximum tolerable semaglutide dose given.
Measured: From baseline to 26 weeks of treatment
Change in heavy drinking days adjusted for weightloss
Change in heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)) and weight loss during the 26 weeks of treatment
Measured: From baseline to 26 weeks of treatment
Total alcohol consumption
Change in total alcohol consumption /gram/last 30 consecutive days)
Measured: From baseline to 26 weeks of treatment
Drinks per day
Change in total drinks per day (last 30 consecutive days)
Measured: From baseline to 26 weeks of treatment
Days without alcohol consumption
Number of days without alcohol consumption in the last 30 consecutive days
Measured: From baseline to 26 weeks of treatment
Time to relapse
Time to relapse, defined as the time to first alcohol intake
Measured: From baseline to 26 weeks of treatment
Time to relapse (heavy drinking day)
Time to first heavy drinking day
Measured: From baseline to 26 weeks of treatment
World Health Organization (WHO) Risk Levels of Alcohol Consumption
Change in WHO alcohol risk level in the last 30 consecutive days, measured with the validated timeline follow-back (TLFB) method.
Measured: From baseline to 26 weeks of treatment
Penn Alcohol Craving Scale (PACS) score
Change in Penn Alcohol Craving Scale (PACS) score. Minimum score = 0, maximum score =30. A high score means a worse outcome.
Measured: From baseline to 26 weeks of treatment
Alcohol Use Disorder Identification Test (AUDIT) score
Change in Alcohol Use Disorder Identification Test (AUDIT) score. Minimum score = 0, maximum score =40. A high score means a worse outcome.
Measured: From baseline to 26 weeks of treatment
Drug Use Disorders Identification Test (DUDIT) score
Change in Drug Use Disorders Identification Test (DUDIT) score. Minimum score = 0, maximum score =44. A high score means a worse outcome.
Measured: From baseline to 26 weeks of treatment
Fibrosis-4 (FIB4) score
Change in Fibrosis-4 (FIB4) score, calculated from the parameters: the patient's age, blood aspartate aminotransferase levels (ASAT), thrombocytes and alanine transaminase (ALAT). A higher score means a worse outcome.
Measured: From baseline to 26 weeks of treatment
Measure of life quality - World Health Organization Quality of Life brief (WHOQOL-BREF) score
Change in Measures of Health (WHOQOL-BREF) score. Minimum score = 26, maximum score =130. Higher scores mean a better outcome in items 1-2 + 10-25. A higher score in items 3-9 + 26 means a worse outcome.
Measured: From baseline to 26 weeks of treatment
Fagerströms Test for Nicotine Dependence score
Change in Fagerströms Test for Nicotine Dependence score. Minimum score = 0, maximum score =10. A high score means a worse outcome.
Measured: From baseline to 26 weeks of treatment
Gamma-glutamyl transferase (GGT)
Change in blood gamma-glutamyl transferase (GGT)
Measured: From baseline to 26 weeks of treatment
Alanine transaminase (ALAT)
Change in blood alanine transaminase (ALAT)
Measured: From baseline to 26 weeks of treatment
Phosphatidyl ethanol (PEth)
Change in plasma levels of phosphatidyl ethanol (PEth)
Measured: From baseline to 26 weeks of treatment
Mean cell volume (MCV)
Change in blood mean cell volume (MCV)
Measured: From baseline to 26 weeks of treatment
Body weight
Change in Body weight
Measured: From baseline to 26 weeks of treatment
Blood pressure
Change in blood pressure (both systolic and diastolic)
Measured: From baseline to 26 weeks of treatment
Pulse
Change in pulse
Measured: From baseline to 26 weeks of treatment
Waist circumference
Change in waist circumference
Measured: From baseline to 26 weeks of treatment
Glycaemic control parameters
Change in HbA1c
Measured: From baseline to 26 weeks of treatment
MRS brain gamma-aminobutyric acid (GABA) levels
Change in brain GABA levels (cortical, caudate, and putamen) assessed by MRS brain scans
Measured: From baseline to 26 weeks of treatment
fMRI alcohol cue-reactivity
Change in brain alcohol cue-response in reward-processing brain regions (ventral and dorsal striatum, puta-men, nucleus accumbens, and caudate), including the septal area assessed by fMRI brain scans
Measured: From baseline to 26 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start13 Jun 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Centre Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Neurobiology Research Unit
- Responsible party
- Principal investigator, Anders Fink-Jensen, MD, DMSci, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Anders Fink-Jensen, MD, DMSc, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895643
- Sponsor's protocol ID
- The SEMALCO study
- Other IDs
- U1111-1286-6919
- Acronym
- SEMALCO
- Status last verified
- Aug 2025
- First submitted
- 26 May 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Klausen MK, Justesen SK, Pedersen JN, Rasmussen L, Jensen A, Jensen ME, Knorr UB, Bergmann ML, Holst JJ, Hartmann B, Koob GF, Benveniste H, Volkow ND, Ekstrom CT, Knudsen GM, Vilsboll T, Fink-Jensen A. Once-weekly semaglutide versus placebo in patients with alcohol use disorder and comorbid obesity: a randomised, double-blind, placebo-controlled trial. Lancet. 2026 May 2;407(10540):1687-1698. doi: 10.1016/S0140-6736(26)00305-3.
PubMed 42070571Jensen ME, Klausen MK, Bergmann ML, Knudsen GM, Vilsboll T, Stove C, Fink-Jensen A. Blood phosphatidylethanol measurements indicate GLP-1 receptor stimulation causes delayed decreases in alcohol consumption. Alcohol Clin Exp Res (Hoboken). 2025 May;49(5):1161-1165. doi: 10.1111/acer.70041. Epub 2025 Mar 23.
PubMed 40123107Klausen MK, Kuzey T, Pedersen JN, Justesen SK, Rasmussen L, Knorr UB, Mason G, Ekstrom CT, Holst JJ, Koob G, Benveniste H, Volkow ND, Knudsen GM, Vilsboll T, Fink-Jensen A. Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial). BMJ Open. 2025 Jan 8;15(1):e086454. doi: 10.1136/bmjopen-2024-086454.
PubMed 39779270
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?
- ClinicalTrials.gov ID
- NCT05895643
- Acronym / sponsor ID
- SEMALCO / The SEMALCO study
- Keywords
- GLP-1, Glucagon-like peptide 1, semaglutide, fMRI, MRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Psychiatric Centre RigshospitaletUniversity, hospital or other
- Collaborators
- Neurobiology Research Unit
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Jun 2023 (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 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI>30 kg/m2).
Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26.
The primary endpoint is the percentage-point reduction in total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.
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 |
|---|---|---|
| semaglutide | Experimental | Drug: Semaglutide Injectable ProductWegovy once-weekly s.c.titrated to a maximum dose of 2.4 mg |
| placebo | Placebo comparator | Drug: PlaceboSaline s.c. once-weekly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed oral and written consent
- Diagnosed with alcohol dependence according to the criteria of the International Classification of Diseases 10 (ICD-10), and diagnosed with alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Alcohol use disorder identification test (AUDIT) score >15
- Body mass index (BMI) above or equal to 30 kg/m2
- Age 18 - 70 years (both included)
Key exclusion criteria (22 listed)
- Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
- A history of delirium tremens or alcohol withdrawal seizures
- No serious withdrawal symptoms at inclusion (a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)) at baseline examinations
- Present or former neurological disease, including traumatic brain injury
- Type 1 diabetes, type 2 diabetes in poor glycaemic control (defined as HbA1c ≥48 mmol/l or fasting plasma glucose above 7.0 mmol/l at inclusion)
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 |
|---|---|---|
| Semaglutide Injectable ProductAlso: WegovyOnce weekly injections s.c with semaglutide (Wegovy) | Drug | semaglutide |
| PlaceboAlso: BD Posiflush (saline)Once weekly injections s.c with placebo (BD Posiflush) | Drug | placebo |
Primary outcome
Change in heavy drinking days
Time frame: From baseline to 26 weeks of treatment
Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)). A heavy drinking day is defined as more than 60/48 grams (men/women) of alcohol in one day, measured with the validated timeline follow-back (TLFB) method.
25 secondary outcomes
Change in heavy drinking days adjusted for maximum tolerable semaglutide dose given
Time frame: From baseline to 26 weeks of treatment
Change in heavy drinking days adjusted for weightloss
Time frame: From baseline to 26 weeks of treatment
Total alcohol consumption
Time frame: From baseline to 26 weeks of treatment
Drinks per day
Time frame: From baseline to 26 weeks of treatment
Days without alcohol consumption
Time frame: From baseline to 26 weeks of treatment
Time to relapse
Time frame: From baseline to 26 weeks of treatment
Time to relapse (heavy drinking day)
Time frame: From baseline to 26 weeks of treatment
World Health Organization (WHO) Risk Levels of Alcohol Consumption
Time frame: From baseline to 26 weeks of treatment
Penn Alcohol Craving Scale (PACS) score
Time frame: From baseline to 26 weeks of treatment
Alcohol Use Disorder Identification Test (AUDIT) score
Time frame: From baseline to 26 weeks of treatment
Drug Use Disorders Identification Test (DUDIT) score
Time frame: From baseline to 26 weeks of treatment
Fibrosis-4 (FIB4) score
Time frame: From baseline to 26 weeks of treatment
Measure of life quality - World Health Organization Quality of Life brief (WHOQOL-BREF) score
Time frame: From baseline to 26 weeks of treatment
Fagerströms Test for Nicotine Dependence score
Time frame: From baseline to 26 weeks of treatment
Gamma-glutamyl transferase (GGT)
Time frame: From baseline to 26 weeks of treatment
Alanine transaminase (ALAT)
Time frame: From baseline to 26 weeks of treatment
Phosphatidyl ethanol (PEth)
Time frame: From baseline to 26 weeks of treatment
Mean cell volume (MCV)
Time frame: From baseline to 26 weeks of treatment
Body weight
Time frame: From baseline to 26 weeks of treatment
Blood pressure
Time frame: From baseline to 26 weeks of treatment
Pulse
Time frame: From baseline to 26 weeks of treatment
Waist circumference
Time frame: From baseline to 26 weeks of treatment
Glycaemic control parameters
Time frame: From baseline to 26 weeks of treatment
MRS brain gamma-aminobutyric acid (GABA) levels
Time frame: From baseline to 26 weeks of treatment
fMRI alcohol cue-reactivity
Time frame: From baseline to 26 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 42070571Klausen MK, Justesen SK, Pedersen JN, Rasmussen L, Jensen A, Jensen ME, Knorr UB, Bergmann ML, Holst JJ, Hartmann B, Koob GF, Benveniste H, Volkow ND, Ekstrom CT, Knudsen GM, Vilsboll T, Fink-Jensen A. Once-weekly semaglutide versus placebo in patients with alcohol use disorder and comorbid obesity: a randomised, double-blind, placebo-controlled trial. Lancet. 2026 May 2;407(10540):1687-1698. doi: 10.1016/S0140-6736(26)00305-3.
- Derived from this study: PubMed 40123107Jensen ME, Klausen MK, Bergmann ML, Knudsen GM, Vilsboll T, Stove C, Fink-Jensen A. Blood phosphatidylethanol measurements indicate GLP-1 receptor stimulation causes delayed decreases in alcohol consumption. Alcohol Clin Exp Res (Hoboken). 2025 May;49(5):1161-1165. doi: 10.1111/acer.70041. Epub 2025 Mar 23.
- Derived from this study: PubMed 39779270Klausen MK, Kuzey T, Pedersen JN, Justesen SK, Rasmussen L, Knorr UB, Mason G, Ekstrom CT, Holst JJ, Koob G, Benveniste H, Volkow ND, Knudsen GM, Vilsboll T, Fink-Jensen A. Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial). BMJ Open. 2025 Jan 8;15(1):e086454. doi: 10.1136/bmjopen-2024-086454.
- Individual participant dataSharing planned: Yes
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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
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
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 Semaglutide Injectable Product in people with Alcohol Abuse and Alcohol Addiction, run by Psychiatric Centre Rigshospitalet at 1 site 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 6 inclusion and 22 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: finished, as of the sponsor's last update on 5 Aug 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in heavy drinking days (time frame: From baseline to 26 weeks of treatment). 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 NCT05895643, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.