Alcoholism Clinical Trial
Official title:
Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial
Background: Alcohol is the leading psychoactive substance consumed in France, with about 15
million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA)
considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for
women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its
incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness,
extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without
appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.
Methods/Design: This prospective, randomised, controlled study versus placebo will be
conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake
higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary
objective is to determine whether Baclofen is more efficient than placebo in preventing
restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation
duration, length of ICU stay, cumulative doses of sedatives and painkillers received within
28 days of ICU admission. Restlessness-related side effects are defined as unplanned
extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device
removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be
guided by creatinine clearance assessment once a day.
Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA
is a randomised study assessing the capacity of Baclofen to prevent agitation in
mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is
expected to end in December 2019.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05054738 -
CRP and S&A for Inpatient Veterans
|
N/A | |
| Completed |
NCT02233738 -
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
|
N/A | |
| Completed |
NCT05877807 -
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
|
||
| Completed |
NCT00000437 -
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
|
Phase 4 | |
| Completed |
NCT00536146 -
The Stress-Hormone System in Alcohol-Dependent Subjects
|
N/A | |
| Terminated |
NCT00890149 -
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
|
Phase 2 | |
| Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
| Completed |
NCT02939352 -
The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues
|
Early Phase 1 | |
| Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
| Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
| Completed |
NCT01389297 -
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
|
N/A | |
| Completed |
NCT00768508 -
Combined Pharmacotherapies for Alcoholism
|
Phase 3 | |
| Completed |
NCT01760785 -
Valproate for Mood Swings and Alcohol Use Following Head Injury
|
N/A | |
| Completed |
NCT01113164 -
Matching Genotypes and Serotonergic Medications for Alcoholism
|
Phase 1 | |
| Terminated |
NCT02842528 -
Cognitive Vulnerability Factors in Alcohol-dependence
|
N/A | |
| Completed |
NCT00127231 -
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
|
N/A | |
| Completed |
NCT00367575 -
An Internet-based Intervention for Problem Drinking
|
N/A | |
| Completed |
NCT00167687 -
Prazosin Alcohol Dependence IVR Study
|
Phase 4 | |
| Completed |
NCT00583440 -
12-step Facilitation for the Dually Diagnosed
|
Phase 1/Phase 2 | |
| Completed |
NCT00223639 -
New Medications to Treat Alcohol Dependence
|
Phase 2 |