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Baclofen Withdrawal

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41. Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: 30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20), 30 sex and age-matched healthy controls, over 18, informed consent. Exclusion Criteria: opiate-treatment, contra-indications for Nalmefene and/or Baclofen, unstable psychiatric disorder, pregnancy, acute withdrawal syndrome. Contacts and Locations (...) Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please

2016 Clinical Trials

42. Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France

of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication. The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy. Condition or disease Alcohol Drinking Cirrhosis Alcohol Withdrawal Detailed Description: Numerous centers of the French research group of the national association (...) for additonal information Responsible Party: Camille Barrault, Dr, Centre Hospitalier Intercommunal Creteil ClinicalTrials.gov Identifier: Other Study ID Numbers: OBADE First Posted: July 18, 2016 Last Update Posted: February 6, 2019 Last Verified: February 2019 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Keywords provided by Camille Barrault, Centre Hospitalier Intercommunal Creteil: baclofen alcohol withdrawal Additional relevant MeSH terms: Layout table for MeSH terms

2016 Clinical Trials

43. Randomized placebo-controlled study of baclofen in the treatment of muscle cramps in patients with liver cirrhosis. (Abstract)

an informed consent to participate in this study. They were recruited from the Department of Tropical Medicine-Tanta University Hospital. They were randomized to receive either baclofen or placebo for 3 months. Patients were followed monthly and 1 month after withdrawal. At each visit, the clinicoepidemiological data were recorded, the muscle cramp questionnaire was filled, and any drug-related side effects were reported.In the baclofen group, the frequency of muscle cramps decreased significantly after 1 (...) and 3 months of treatment (P<0.005), with a significant relapse after withdrawal (P<0.001). Patients receiving baclofen showed a significant decrease in the severity and duration of muscle cramps (P<0.001). After 3 months of baclofen therapy at a dose of 30 mg/day, muscle cramps disappeared completely in 72%, reduced in 20%, and led to no change in 8% of patients. No significant changes in the frequency, severity, and duration of muscle cramps were noted in the placebo group. There were few

2016 European journal of gastroenterology & hepatology Controlled trial quality: uncertain

44. Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial. Full Text available with Trip Pro

Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial. 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 (...) . The primary objective is to determine whether baclofen is more efficient than placebo in preventing restlessness-related side effects in the ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, and cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects in the ICU are defined as unplanned extubation, medical disposal removal (such as urinary catheter, venous or arterial line or surgical drain), falling out

2016 Trials Controlled trial quality: predicted high

45. A Randomized Dose Escalation Study of Intravenous Baclofen in Healthy Volunteers: Clinical Tolerance and Pharmacokinetics. (Abstract)

A Randomized Dose Escalation Study of Intravenous Baclofen in Healthy Volunteers: Clinical Tolerance and Pharmacokinetics. Abrupt discontinuation of baclofen can result in a potentially severe withdrawal syndrome. The current treatment for baclofen withdrawal is inadequate, resulting in a critical need to develop an alternative method to prevent or treat this withdrawal syndrome.To evaluate the safety profile and pharmacokinetics of oral (PO) and investigational intravenous (IV) baclofen (...) formulations at clinically relevant doses.Randomized, open-label, dose-escalation, crossover study.Contract Research Organization (CRO).Three cohorts of 12 healthy adults received single doses of PO baclofen (10 mg, 15 mg or 20 mg) and 10-minute infusions of IV baclofen (7.5 mg, 11.5 mg, or 15 mg) with a minimum 48-hour wash-out period. The third cohort also received a 60-minute infusion of 15 mg IV baclofen after an additional 48-hour wash-out period.Subjects were observed in a CRO for 24 hours after each

2016 PM & R : the journal of injury, function, and rehabilitation Controlled trial quality: uncertain

46. Baclofen as relapse prevention in the treatment of gamma-hydroxybutyrate dependence: a case series. (Abstract)

Baclofen as relapse prevention in the treatment of gamma-hydroxybutyrate dependence: a case series. In the last decade, gamma-hydroxybutyrate (GHB) abuse and dependence have increased. It has been reported that GHB dependence has a high rate of relapse, serious complications of intoxication, and a potentially life-threatening withdrawal syndrome. Nevertheless, in clinical practice, there is no known medical treatment to support GHB relapse prevention. We describe a case series of patients who (...) were supported through an off-label treatment with baclofen to avoid a relapse into GHB abuse, for a period of 12 weeks. Nine of 11 patients did not relapse while taking a dose ranging from 30 to 60 mg per day, one patient relapsed after 5 weeks, and one stopped after 7 weeks. Baclofen was well tolerated; patients reported mild side effects such as fatigue, nausea, dry mouth, excessive sweating, and depressive feelings. Although systematic evidence is still lacking, our practice-based experience

2015 Journal of Clinical Psychopharmacology

47. Increase of baclofen intoxications: risks involved and management. (Abstract)

Increase of baclofen intoxications: risks involved and management. Baclofen has been increasingly used in the treatment of alcohol withdrawal syndrome (AWS). We present a patient with AWS and psychiatric comorbidity who ingested 700 mg of baclofen. ICU admission was necessary for ventilatory support and symptomatic treatment. The patient was dismissed without sequelae.

2014 Netherlands Journal of Medicine

48. Baclofen in the management of cannabis dependence syndrome Full Text available with Trip Pro

Baclofen in the management of cannabis dependence syndrome Cannabis is the most commonly used illicit drug in the world. However, only few studies have shown the efficacy of pharmacologic agents in targeting cannabis withdrawal symptoms or reducing the reinforcing effects of cannabis. Baclofen has been shown to reduce cannabis withdrawal symptoms and the subjective effects of cannabis. We think that the clinical utility of baclofen for cannabis dependence is a reasonable approach. A case report (...) using baclofen is presented and provides preliminary support for the use of baclofen in the management of cannabis dependence.

2014 Therapeutic Advances in Psychopharmacology

49. Management of Acute Alcohol Withdrawal Syndrome in Critically Ill Patients. Full Text available with Trip Pro

-resistant patients appears beneficial in rapidly improving symptoms. This review highlights the results of recent promising studies published between 2011 and 2015 evaluating adjunctive therapies for BZD-resistant alcohol withdrawal such as antiepileptics, baclofen, dexmedetomidine, ethanol, ketamine, phenobarbital, propofol, and ketamine. We provide guidance on the places in therapy for select agents for management of critically ill patients in the presence of AWS.© 2016 Pharmacotherapy Publications (...) Management of Acute Alcohol Withdrawal Syndrome in Critically Ill Patients. Approximately 16-31% of patients in the intensive care unit (ICU) have an alcohol use disorder and are at risk for developing alcohol withdrawal syndrome (AWS). Patients admitted to the ICU with AWS have an increased hospital and ICU length of stay, longer duration of mechanical ventilation, higher costs, and increased mortality compared with those admitted without an alcohol-related disorder. Despite the high

2016 Pharmacotherapy

50. Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers

the next three subjects will receive 15 mg baclofen intravenously, and two or more days later the last three subjects will receive 20 mg IV baclofen. The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome. Condition or disease Intervention/treatment Phase Safety and Pharmacokinetics of Intravenous Baclofen Drug: Intravenous baclofen Phase 1 Study Design Go (...) to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 9 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Prevention of Baclofen Withdrawal Syndrome: Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers Study Start Date : January 2014 Actual Primary Completion Date : June 2014 Actual Study Completion Date : June 2014 Resource links provided by the National

2013 Clinical Trials

51. A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial

A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial Safety Study of SPARC1104 - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (...) of contraception must have started at least 3 months prior to trial entry. If female, negative pregnancy test result at Screening Diagnosed with MS and a known history of spasticity Meet one of the following criteria o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff

2013 Clinical Trials

52. Oral and IV Baclofen in Adult Volunteers

baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1:1 manner. The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome. Condition or disease Intervention/treatment Phase Baclofen Withdrawal Syndrome Drug: Oral baclofen Drug: Intervenous baclofen Phase 1 Study (...) Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 12 participants Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers Study Start Date : January 2013 Actual Primary Completion Date : January 2014 Actual Study Completion Date

2012 Clinical Trials

53. Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

: Ethypharm Information provided by (Responsible Party): Ethypharm Study Details Study Description Go to Brief Summary: The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions. Condition or disease Intervention/treatment Phase Alcohol Dependence Drug: Baclofen Drug: Placebo (for baclofen) Phase 3 Study Design Go to Layout table (...) Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more

2012 Clinical Trials

54. Baclofen in the Treatment of Alcoholic Liver Disease

Baclofen in the Treatment of Alcoholic Liver Disease Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Baclofen (...) : National Health and Medical Research Council, Australia University of Sydney Information provided by (Responsible Party): Professor Paul Haber, South West Sydney Local Health District Study Details Study Description Go to Brief Summary: To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial. Condition or disease Intervention/treatment

2012 Clinical Trials

55. Baclofen for Treating Anxiety and Alcoholism

or hypersensitivity to baclofen. Participants who have significant alcohol withdrawal symptoms, defined as a CIWA-Ar > 8. History of epilepsy or alcohol-related seizures. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751386 Locations Layout table for location (...) Baclofen for Treating Anxiety and Alcoholism Baclofen for Treating Anxiety and Alcoholism - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Baclofen for Treating Anxiety and Alcoholism The safety

2012 Clinical Trials

56. Baclofen in dialysis patients: Just say no!

complaints of AKI and neurotocity (myoclonus) with just 1 day h/o baclofen use (it was prn). I am wondering if there is any association of AKI with baclofen as well? Fabrice GANKAM said... Hih John, Just wanted to point out that we had a patient who develloped severe baclofen withdrawal syndrome after kidney transplant. 42 yo with HTN, severe spasticity and ESRD from urogenital malformation (in the setting of congential CNS and spinal cord malformation). The patient was stable on baclofen daily pre (...) Baclofen in dialysis patients: Just say no! Renal Fellow Network: Baclofen in dialysis patients: Just say no! | | | | | Wednesday, July 16, 2014 Baclofen in dialysis patients: Just say no! At our hospital, we started noticing a pattern of admissions among some of our maintenance dialysis patients. In one case, an elderly woman with DM, peripheral arterial disease, and ESRD on thrice weekly hemodialysis was sent to the emergency department from her nursing facility for altered mental status. She

2014 Renal Fellow Network

57. Treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. Full Text available with Trip Pro

Treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS).To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS.Prospective, randomized, double-blind, placebo-controlled clinical study.Two tertiary-care hospitals in Duluth, Minnesota.Inpatient adults admitted for any (...) reason (including AWS) judged to be at high risk for AWS.Inpatients who developed symptoms of AWS received symptom-triggered benzodiazepine treatment using lorazepam by standard protocol, and were randomized to receive baclofen 10 mg or placebo, 3 times per day, orally.AWS severity was assessed using the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar); lorazepam dose was monitored.Seventy-nine subjects were enrolled. The 44 subjects who developed symptoms of AWS were

2011 Journal of hospital medicine : an official publication of the Society of Hospital Medicine Controlled trial quality: predicted high

58. Withdrawal Syndromes (Treatment)

a benzodiazepine or phenobarbital, in a maintenance dose for a few days followed by a gradually decreasing dose over 2-3 weeks. Gamma hydroxybutyrate (GHB) withdrawal can initially be treated with high doses of benzodiazepines, although anecdotally, refractory cases have responded to other sedative agents, such as pentobarbital, chloral hydrate, and baclofen. [ , ] Treatment of opioid withdrawal in the emergency department (ED) is typically limited to supportive measures such as antiemetics (eg, ondansetron (...) that barbiturates, alone or in combination with benzodiazepines, are at least as effective as benzodiazepines in the treatment of alcohol withdrawal syndrome, with acceptable tolerability and safety profiles similar to those of benzodiazepines in this setting. [ ] Other agents used in combination therapy have included baclofen, [ ] haloperidol, carbamazepine, [ ] valproic acid, [ ] clonidine, [ ] and beta-blockers (atenolol). [ ] Dexmedetomidine is a newer intravenous α-2 agonist (similar to clonidine but more

2014 eMedicine Emergency Medicine

59. Withdrawal Syndromes (Follow-up)

, Benouda L, Champ-Rigot L, Labombarda F. Takotsubo cardiomyopathy triggered by alcohol withdrawal. Drug Alcohol Rev . 2011 Jul. 30(4):434-7. . Otero-Anton E, Gonzalez-Quintela A, Saborido J, Torre JA, Virgos A, Barrio E. Prolongation of the QTc interval during alcohol withdrawal syndrome. Acta Cardiol . 1997. 52(3):285-94. . LeTourneau JL, Hagg DS, Smith SM. Baclofen and gamma-hydroxybutyrate withdrawal. Neurocrit Care . 2008. 8(3):430-3. . . Ghio L, Cervetti A, Respino M, Belvederi Murri M, Amore M (...) of Refractory Alcohol Withdrawal Syndrome: A Review of the Literature. Pharmacotherapy . 2016 Apr. 36 (4):433-42. . Lyon JE, Khan RA, Gessert CE, Larson PM, Renier CM. Treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. J Hosp Med . 2011 Oct. 6(8):469-74. . Eyer F, Schreckenberg M, Hecht D, Adorjan K, Schuster T, Felgenhauer N, et al. Carbamazepine and valproate as adjuncts in the treatment of alcohol withdrawal syndrome: a retrospective cohort study

2014 eMedicine Emergency Medicine

60. Withdrawal Syndromes (Overview)

a benzodiazepine or phenobarbital, in a maintenance dose for a few days followed by a gradually decreasing dose over 2-3 weeks. GHB withdrawal can initially be treated with high doses of benzodiazepines, though anecdotally, refractory cases have responded to other sedative agents, such as pentobarbital, chloral hydrate, and baclofen. Opioid withdrawal is treated with a long-acting opioid agonist, such as methadone 20-35 mg/d or buprenorphine 4-16 mg/d, and then tapered over days to weeks. Clonidine 0.1-0.2 mg (...) , Champ-Rigot L, Labombarda F. Takotsubo cardiomyopathy triggered by alcohol withdrawal. Drug Alcohol Rev . 2011 Jul. 30(4):434-7. . Otero-Anton E, Gonzalez-Quintela A, Saborido J, Torre JA, Virgos A, Barrio E. Prolongation of the QTc interval during alcohol withdrawal syndrome. Acta Cardiol . 1997. 52(3):285-94. . LeTourneau JL, Hagg DS, Smith SM. Baclofen and gamma-hydroxybutyrate withdrawal. Neurocrit Care . 2008. 8(3):430-3. . . Ghio L, Cervetti A, Respino M, Belvederi Murri M, Amore M. Management

2014 eMedicine Emergency Medicine

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