Alcohol Withdrawal SyndromePhase 4NCT00249366
Treatment of Alcohol Withdrawal in Hospital Patients
A Phase 4 study testing Lorazepam (drug) and Lorazepam in people with Alcohol Withdrawal Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol Withdrawal Syndrome
- What is being tested?
- Lorazepam (drug) and Lorazepam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to May 2003
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
- Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment
- Patients on the General Internal Medicine service
Who cannot join
- Unable to give informed consent
- Chronically maintained on prescription sedative-hypnotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
About this study
Official title: Acute Drug Withdrawal in a General Medical Setting
The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.
Read the detailed description
Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.
- Conditions
- Alcohol Withdrawal Syndrome
- Being tested
- Lorazepam (drug), Lorazepam
- Keywords
- Alcohol withdrawal, Symptom-triggered therapy, Fixed-schedule therapy, CIWA-Ar, Lorazepam (drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorazepam (drug)Drug
Also called Ativan
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
LorazepamDrug
Also called Ativan
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
| Study group | Role | What they receive |
|---|---|---|
| Fixed-schedule treatment | Active comparator | Fixed-schedule administration of lorazepam for alcohol withdrawal Receives: Drug: Lorazepam (drug); Drug: Lorazepam |
| Symptom-triggered treatment | Active comparator | Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar) Receives: Drug: Lorazepam (drug); Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal Assessment Scores
Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms
Measured: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Total Dose of Lorazepam
Differences in total amount of lorazepam administered between protocol groups
Measured: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Protocol Errors
Percentage of protocol errors between study arms, such as administration of an inappropriate lorazepam dose (inconsistent with CIWA-Ar score); excluded complications due to comorbid medical conditions.
Measured: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startApr 2001
- Primary completionMay 2003
- Study completionMay 2003
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 Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Michael F. Weaver, MD, Principal investigator, Virginia Commonwealth University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249366
- Sponsor's protocol ID
- NIAAAWEA-K2300222-A
- Other IDs
- K23AA000222
- Status last verified
- Apr 2016
- First submitted
- 3 Nov 2005
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. doi: 10.1300/j069v25n02_03.
PubMed 16785215
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Drug Withdrawal in a General Medical Setting
- ClinicalTrials.gov ID
- NCT00249366
- Acronym / sponsor ID
- NIAAAWEA-K2300222-A
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- Alcohol withdrawal, Symptom-triggered therapy, Fixed-schedule therapy, CIWA-Ar, Lorazepam (drug)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 7 Nov 2005 (estimated)
- 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 purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.
Detailed description
Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-schedule treatment | Active comparator | Drug: Lorazepam (drug), Drug: LorazepamFixed-schedule administration of lorazepam for alcohol withdrawal |
| Symptom-triggered treatment | Active comparator | Drug: Lorazepam (drug), Drug: LorazepamSymptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
- Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment
- Patients on the General Internal Medicine service
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Chronically maintained on prescription sedative-hypnotics
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 |
|---|---|---|
| Lorazepam (drug)Also: AtivanLorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients | Drug | Fixed-schedule treatment, Symptom-triggered treatment |
| LorazepamAlso: AtivanLorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients | Drug | Fixed-schedule treatment, Symptom-triggered treatment |
Primary outcome
Withdrawal Assessment Scores
Time frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms
Total Dose of Lorazepam
Time frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Differences in total amount of lorazepam administered between protocol groups
Protocol Errors
Time frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Percentage of protocol errors between study arms, such as administration of an inappropriate lorazepam dose (inconsistent with CIWA-Ar score); excluded complications due to comorbid medical conditions.
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 11 Apr 2016.
- Results publication: PubMed 16785215Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. doi: 10.1300/j069v25n02_03.
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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.
Michael F. Weaver, MD principal investigator
Virginia Commonwealth University Medical Center
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 Lorazepam (drug) and Lorazepam in people with Alcohol Withdrawal Syndrome, run by Virginia Commonwealth University 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 2 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 11 Apr 2016. 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. 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?
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?
Withdrawal Assessment Scores (time frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days). The study lists 3 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 NCT00249366, 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 11 Apr 2016.