Alcohol Use DisorderPhase 4NCT03293017
Baclofen in Managing Acute Alcohol Withdrawal
A Phase 4 study testing Diazepam 10 MG, Baclofen 30mg and Baclofen 60mg in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal
- What is being tested?
- Diazepam 10 MG, Baclofen 30mg and Baclofen 60mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2016to 1 Feb 2022
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
- Be able to sign informed consent.
- Be male/female aged 18-60
- Primary diagnosis of alcohol use disorder.
Who cannot join
- Pregnancy and breastfeeding.
- Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
- Psychosis, confusion and acute mania.
- Parkinson's disease.
- Use of tricyclic antidepressants.
- Use of opioids.
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- Known baclofen or benzodiazepine sensitivity or allergy.
- Unable to take oral medication.
- epidermal growth factor receptor (EGFR) < 60 (blood samples are routinely performed at intake).
- Prior diagnosis of epilepsy.
- Lactose intolerance.
Trial locations and contacts
1 site in 1 country.
Cleo L Crunelle, PhD contact
Sami Jegham, MD contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Brussels
Brussels, 1090
Cleo L Crunelle, PhD, nacstudie@gmail.com
About this study
Official title: Baclofen Bij de Behandeling Van Acute Alcoholontwenning
The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.
Read the detailed description
The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group.
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Being tested
- Diazepam 10 MG, Baclofen 30mg, Baclofen 60mg
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam 10 MGDrug
If a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg.
Baclofen 30mgDrug
Baclofen 30 mg/day given over three gifts daily
Baclofen 60mgDrug
Baclofen 60 mg/day given over three gifts daily
| Study group | Role | What they receive |
|---|---|---|
| Baclofen 30 mg/day | Experimental | baclofen 30 mg/day Receives: Drug: Diazepam 10 MG; Drug: Baclofen 30mg |
| Baclofen 60 mg/day | Experimental | Not described Receives: Drug: Diazepam 10 MG; Drug: Baclofen 60mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Diazepam 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for additional diazepam
Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal
Measured: Measured 7 days after the start of alcohol withdrawal
Secondary outcomes (1)
Dosage of additional diazepam needed
The difference between the total dosages of additional diazepam needed between the three study arms
Measured: Measured 7 days after the start of alcohol withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Feb 2016
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frieda Matthys, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293017
- Sponsor's protocol ID
- 22112015
- Status last verified
- Nov 2020
- First submitted
- 19 Jun 2017
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen Bij de Behandeling Van Acute Alcoholontwenning
- ClinicalTrials.gov ID
- NCT03293017
- Acronym / sponsor ID
- 22112015
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 26 Sep 2017 (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 study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.
Detailed description
The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baclofen 30 mg/day | Experimental | Drug: Diazepam 10 MG, Drug: Baclofen 30mgbaclofen 30 mg/day |
| Baclofen 60 mg/day | Experimental | Drug: Diazepam 10 MG, Drug: Baclofen 60mg |
| Placebo | Placebo comparator | Drug: Diazepam 10 MG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
- Be able to sign informed consent.
- Be male/female aged 18-60
- Primary diagnosis of alcohol use disorder.
Key exclusion criteria (11 listed)
- Pregnancy and breastfeeding.
- Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
- Psychosis, confusion and acute mania.
- Parkinson's disease.
- Use of tricyclic antidepressants.
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 |
|---|---|---|
| Diazepam 10 MGIf a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg. | Drug | Baclofen 30 mg/day, Baclofen 60 mg/day, Placebo |
| Baclofen 30mgBaclofen 30 mg/day given over three gifts daily | Drug | Baclofen 30 mg/day |
| Baclofen 60mgBaclofen 60 mg/day given over three gifts daily | Drug | Baclofen 60 mg/day |
Primary outcome
Need for additional diazepam
Time frame: Measured 7 days after the start of alcohol withdrawal
Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal
1 secondary outcome
Dosage of additional diazepam needed
Time frame: Measured 7 days after the start of alcohol withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Cleo L Crunelle, PhD contact
Sami Jegham, MD contact
Frieda Matthys, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diazepam 10 MG, Baclofen 30mg and Baclofen 60mg in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 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 4 Nov 2021. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cleo L Crunelle, PhD (nacstudie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for additional diazepam (time frame: Measured 7 days after the start of alcohol withdrawal). 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 4 Nov 2021.