AlcoholismPhase 2BACLOFEN IIINCT01937364
Preventing Alcohol Withdrawal With Oral Baclofen
A Phase 2 study testing Baclofen in people with Alcoholism and Alcohol Withdrawal, run by Essentia Health at 2 sites in United States.
Trial summary
The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholism, Alcohol Withdrawal
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
- Patient placed on AWS watch protocol by admitting physicians.
Who cannot join
- Unable to provide informed consent
- Unable to take swallow oral medications (tube-fed patients are to be excluded)
- Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score >8 at baseline
- No alcohol intake for ≥ 48 hours or AUDIT score <12 at baseline
- Baclofen use at baseline
- Baclofen sensitivity
Show all 9Show fewer
- Hospital discharge anticipated in within 48 hours
- Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)
- Other active drug dependence (except tobacco)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Mary's Medical Center
Duluth, Minnesota, 55805
Essentia Health Innovis Hospital
Fargo, North Dakota, 58103
About this study
Official title: Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.
- Conditions
- Alcoholism, Alcohol Withdrawal
- Being tested
- Baclofen, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Also called lioresal
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
PlaceboDrug
Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. Receives: Drug: Placebo |
| Baclofen | Active comparator | Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. Receives: Drug: Baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate or Severe Alcohol Withdrawal Syndrome
Moderate or severe AWS was defined as a CIWA-AR score of at least 11.
Measured: 72 hours
Secondary outcomes (2)
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment
Range: 0 to 67; larger values indicate greater severity
Measured: 72 hours
Peak and Total Benzodiazepine Dose Required
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: The enrollment in the study was too limited for meaningful data analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlcoholismStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey E Lyon, Essentia Health
- Investigators
- Jeffrey E Lyon, MD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937364
- Sponsor's protocol ID
- EIRH-13-1134
- Acronym
- BACLOFEN III
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2013
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01937364
- Acronym / sponsor ID
- BACLOFEN III / EIRH-13-1134
- Conditions
- Alcoholism, Alcohol Withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment in the study was too limited for meaningful data analysis.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. |
| Baclofen | Active comparator | Drug: BaclofenBaclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
- Patient placed on AWS watch protocol by admitting physicians.
Key exclusion criteria (9 listed)
- Unable to provide informed consent
- Unable to take swallow oral medications (tube-fed patients are to be excluded)
- Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score >8 at baseline
- No alcohol intake for ≥ 48 hours or AUDIT score <12 at baseline
- Baclofen use at baseline
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 |
|---|---|---|
| BaclofenAlso: lioresalBaclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. | Drug | Baclofen |
| PlaceboIdentical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. | Drug | Placebo |
Primary outcome
Moderate or Severe Alcohol Withdrawal Syndrome
Time frame: 72 hours
Moderate or severe AWS was defined as a CIWA-AR score of at least 11.
2 secondary outcomes
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment
Time frame: 72 hours
Peak and Total Benzodiazepine Dose Required
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jeffrey E Lyon, MD principal investigator
Essentia Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baclofen in people with Alcoholism and Alcohol Withdrawal, run by Essentia Health at 2 sites 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 May 2017. 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 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?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Moderate or Severe Alcohol Withdrawal Syndrome (time frame: 72 hours). 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 5 May 2017.