Acute Alcohol WithdrawalDATANCT00936377
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
A study testing Dexmedetomidine in people with Acute Alcohol Withdrawal, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Alcohol Withdrawal
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2012
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
- Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
- Informed consent within 36 hours of qualifying for the study.
Who cannot join
- Patients < 18 years of age or > 85 years of age.
- Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
- Patients with alcohol withdrawal not requiring ICU admission.
- Patients receiving epidural administration of medication(s).
- Comatose patients by metabolic or neurologic affectation.
- Patients with active myocardial ischemia or second- or third-degree heart block.
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- Moribund state with planned withdrawal of life support.
- Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
- Pregnant females or females suspected of being pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.
Read the detailed description
The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. The study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. All patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.
- Conditions
- Acute Alcohol Withdrawal
- Being tested
- Dexmedetomidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
PlaceboOther
Normal saline for five days.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine, low dose | Experimental | Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days Receives: Drug: Dexmedetomidine |
| Dexmedetomidine, high dose | Experimental | Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal
Measured: Seven days
Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment
Measured: 12 hours before treatment, 12 hours after treatment on first day of starting study drug
Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment
Measured: 24 hours before treatment, 24 hours after treatment on first day of starting study drug
Secondary outcomes (5)
The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores
Proportion of clinical institute withdrawal assessment (CIWA) Scores listed as severe or moderate 24 Hours after Starting Study Drug. All subjects had at least four CIWA assessments.The CIWA is a ten item scale with each item on the scale scored independently on a 0-7 or 0-4 scale, and the summation of the scores yielding an aggregate value that correlates to the severity of alcohol withdrawal. Ranges of scores are from 0 to 67. Mild alcohol withdrawal is defined with a score less than or equal to 15, moderate with scores of 16 to 20, and severe with any score greater than 20. The ten items evaluated include nausea and vomiting, tremor, sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation.
Measured: Every 2-4 hours for 24 hours after starting study drug
The Occurrence of Adverse Events.
Occurrence of hypotension or bradycardia while on study drug
Measured: Seven days
Plasma Epinephrine Concentrations Across Groups Over Time
Plasma epinephrine concentrations
Measured: Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug
Duration of Study Drug Administration
Measured: The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks
ICU Length of Stay
Measured: The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2012
- Study completionOct 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Alcohol WithdrawalStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Robert MacLaren, PharmD, Principal investigator, University of Colorado School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936377
- Sponsor's protocol ID
- 09-0406
- Acronym
- DATA
- Status last verified
- Apr 2016
- First submitted
- 8 Jul 2009
- Last updated
- 12 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reynolds PM, Mueller SW, MacLaren R. A comparison of dexmedetomidine and placebo on the plasma concentrations of NGF, BDNF, GDNF, and epinephrine during severe alcohol withdrawal. Alcohol. 2015 Feb;49(1):15-9. doi: 10.1016/j.alcohol.2014.11.006. Epub 2015 Jan 22.
PubMed 25638740Mueller SW, Preslaski CR, Kiser TH, Fish DN, Lavelle JC, Malkoski SP, MacLaren R. A randomized, double-blind, placebo-controlled dose range study of dexmedetomidine as adjunctive therapy for alcohol withdrawal. Crit Care Med. 2014 May;42(5):1131-9. doi: 10.1097/CCM.0000000000000141.
PubMed 24351375
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
- ClinicalTrials.gov ID
- NCT00936377
- Acronym / sponsor ID
- DATA / 09-0406
- Conditions
- Acute Alcohol Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.
Detailed description
The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. The study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. All patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine, low dose | Experimental | Drug: DexmedetomidineDexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days |
| Dexmedetomidine, high dose | Experimental | Drug: DexmedetomidineDexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days |
| Placebo | Placebo comparator | Other: PlaceboNormal saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
- Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
- Informed consent within 36 hours of qualifying for the study.
Key exclusion criteria (9 listed)
- Patients < 18 years of age or > 85 years of age.
- Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
- Patients with alcohol withdrawal not requiring ICU admission.
- Patients receiving epidural administration of medication(s).
- Comatose patients by metabolic or neurologic affectation.
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days | Drug | Dexmedetomidine, high dose, Dexmedetomidine, low dose |
| PlaceboNormal saline for five days. | Other | Placebo |
Primary outcome
Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal
Time frame: Seven days
Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment
Time frame: 12 hours before treatment, 12 hours after treatment on first day of starting study drug
Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment
Time frame: 24 hours before treatment, 24 hours after treatment on first day of starting study drug
5 secondary outcomes
The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores
Time frame: Every 2-4 hours for 24 hours after starting study drug
The Occurrence of Adverse Events.
Time frame: Seven days
Plasma Epinephrine Concentrations Across Groups Over Time
Time frame: Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug
Duration of Study Drug Administration
Time frame: The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks
ICU Length of Stay
Time frame: The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25638740Reynolds PM, Mueller SW, MacLaren R. A comparison of dexmedetomidine and placebo on the plasma concentrations of NGF, BDNF, GDNF, and epinephrine during severe alcohol withdrawal. Alcohol. 2015 Feb;49(1):15-9. doi: 10.1016/j.alcohol.2014.11.006. Epub 2015 Jan 22.
- Derived from this study: PubMed 24351375Mueller SW, Preslaski CR, Kiser TH, Fish DN, Lavelle JC, Malkoski SP, MacLaren R. A randomized, double-blind, placebo-controlled dose range study of dexmedetomidine as adjunctive therapy for alcohol withdrawal. Crit Care Med. 2014 May;42(5):1131-9. doi: 10.1097/CCM.0000000000000141.
Related trials for Acute Alcohol Withdrawal
Enrolling by invitationPhase 2/3
Effects of Ketone Supplementation on Acute Alcohol Withdrawal
Alcohol Use Disorder, Alcohol Withdrawal
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.
Robert MacLaren, PharmD principal investigator
University of Colorado School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Acute Alcohol Withdrawal, run by University of Colorado, Denver 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 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: finished, as of the sponsor's last update on 12 May 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. 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?
Yes. Results are posted in the registry (first posted 12 May 2016). 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?
Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal (time frame: Seven 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 NCT00936377, which also lists 2 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 12 May 2016.