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Baclofen Withdrawal

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141. Intrathecal Pump

needle through the skin III. Preparations FDA approved agents to be used in Intrathecal Pumps Ziconotide Off-Label medication uses within Intrathecal Pumps Bupivicaine IV. Complications Pump malfunction with Clonide withdrawal results in hypertensive emergencies with See Less common May occur on attempted pump port refill, if the port site is missed Infection May occur immediately after implantation, however otherwise infections are uncommon Catheter granuloma May result in local mass effect (...) with pressure on spinal cord and risk of injury V. Precautions Interventionist may access side port of pump to withdraw CSF for analysis Do not perform blindly without identifying the course of the catheter XRay catheter region to determine involved levels Perform under fluoroscopy if performing in region of catheter MRI with implanted pump Consult specific pump guide or device consultant Precautions vary by pump Some pumps require medication to be withdrawn from reservoir before MRI due to risk of rapid

2018 FP Notebook

144. Delirium

based on the clinical guidelines The prevention, diagnosis and management of delirium in older people: national guidelines [ ], Delirium: diagnosis, prevention and management [ ] , Care of dying adults in the last days of life [ ] and The Delirium toolkit [ ]. This CKS topic covers the diagnosis of delirium, identification of precipitating factors, and the management of delirium in primary care. It does not cover delirium in people with intoxication and/or withdrawing from drugs or alcohol (...) , confusion. Perception: for example, visual or auditory hallucinations. Physical function: for example, reduced mobility, reduced movement, restlessness, agitation, changes in appetite, sleep disturbance. Social behaviour: for example, lack of cooperation with reasonable requests, withdrawal, or alterations in communication, mood and/or attitude. If any of these behaviour changes are present, a healthcare professional who is trained and competent in diagnosing delirium should carry out a clinical

2016 NICE Clinical Knowledge Summaries

146. Evidence based guidelines for the pharmacological management of substance abuse, harmful use, addiction and comorbidity

, found no benefit in drinking outcomes, indeed this approach might worsen some (Kampman et al., 2009) (Ib). There are a number of medications that may be useful not only in treating withdrawal but also in relapse prevention, and are further described in this section below. These include baclofen, some anti- convulsants (e.g. topiramate) and gamma-hydroxybutyric acid (GHB or sodium oxybate; see Relapse Prevention, Other medica- tions below), but there is limited evidence currently (Caputo and Bernardi (...) in the treatment of these disorders, reviewed key areas and considered the strength of the evidence and clinical implications. The guidelines were drawn up after feedback from participants. The guidelines primarily cover the pharmacological management of withdrawal, short- and long-term substitution, maintenance of abstinence and prevention of complications, where appropriate, for substance abuse or harmful use or addiction as well management in pregnancy, comorbidity with psychiatric disorders and in younger

2012 British Association for Psychopharmacology

149. Problem drinking management in general practice

studied. Among them are baclofen, and topiramate. Baclofen, a gABA-B receptor agonist, has shown to be a promising agent for controlling alcohol withdrawal symptoms as well as reducing alcohol cravings. 22 it can be safely used in cirrhosis. 22 topiramate, a relatively new anticonvulsant, has been studied for managing alcohol dependence with a degree of success. 8 Counselling and group based approaches Psychosocial interventions such as motivational interviewing and cognitive behavioural therapies (...) in nondependent drinkers. For dependent drinkers, treatment steps include assessing need for withdrawal management and developing a comprehensive management plan, which includes consideration of relapse prevention pharmacotherapy and psychosocial interventions. The patient’s right to choose what they drink must be respected, and those who continue to drink in a problematic way can still be assisted, with compassion, within a harm reduction framework. Keywords: alcohol related disorders/management; general

2011 Clinical Practice Guidelines Portal

151. Glycopyrrolate oral solution

7.6.3 Pediatrics and Assessment of Effects on Growth 74 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 74 7.7 Additional Submissions / Safety Issues 74 8 POSTMARKET EXPERIENCE 75 Clinical Review Fred Hyman, DDS, MPH NDA 22-751 Glycopyrrolate Oral Solution 1 mg/5 mL 4 9 APPENDICES 77 9.1 Literature Review/References 77 9.2 Labeling Recommendations 77 9.3 Advisory Committee Meeting 80 Clinical Review Fred Hyman, DDS, MPH NDA 22-751 Glycopyrrolate Oral Solution 1 mg/5 mL 5 Table of Tables

2010 FDA - Drug Approval Package

152. Movantik for Opioid-Related Esophageal Disorders

in subject esophageal symptom scores according to the chest pain symptom questionnaire. Daily Symptom Management [ Time Frame: 28 days ] Mean change from baseline to visit three in subject esophageal symptom scores according to the daily diary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: 42 days ] The occurrence of adverse events and early withdrawal in study group when compared to placebo control group to determine safety and tolerability. Quality of Life [ Time (...) reduction of structural integrity in the wall of the gastrointestinal tract (e.g. peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm) Patients taking baclofen or sucralfate and those unwilling to discontinue prohibited medications. Known history of substance abuse Subject unable to consent or is unwilling to provide informed consent

2016 Clinical Trials

153. A Novel Compound for Alcoholism Treatment: A Translational Strategy

. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria INCLUSION CRITERIA: Male or female individuals 18-70 years old (inclusive) Current Alcohol Use Disorder (AUD) by DSM-5 criteria based on the SCID Most recent urine drug test for illegal drugs of abuse is negative Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score (...) the QTc value that is the longest in duration. BMI less than or equal to 18.5 kg/M(2) or anorexia BMI greater than or equal to 40 kg/m(2) History of epilepsy and/or seizures NOTE: individuals who have a history of alcohol withdrawal seizures may be in the study as long as they have been abstinent from alcohol for at least 2 weeks prior to consent and during that period of abstinence, there were no seizure episodes (otherwise, participant remains not eligible). Most recent blood tests show creatinine

2016 Clinical Trials

154. Assessing Long Term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A

to PXT3003 dose 2 (5 mL) in the extension study (CLN-PXT3003-03) before September 18th 2017 will continue on PXT3003 twice dose 1 (2x5 mL). Condition or disease Intervention/treatment Phase Charcot-Marie-Tooth Disease, Type IA Drug: PXT3003 Phase 3 Detailed Description: PXT3003 is a rational design, fixed combination of low-dose (RS) baclofen, naltrexone hydrochloride and D-sorbitol. The use of PXT3003 in a multicenter, randomised, placebo controlled phase II study (CLN-PXT3003-01) was well-tolerated (...) Frame: 9 or 24 months ] Incidence of adverse events leading to withdrawal of study drug [ Time Frame: 9 or 24 months ] Overall Neuropathy Limitation Scale (ONLS) score, and its arm and leg sub-items [ Time Frame: 9 or 24 months ] Charcot-Marie-Tooth Neuropathy Score - version 2 (CMTNS-V2), and its sub-items [ Time Frame: 9 or 24 months ] Nine-hole Peg Test (9-HPT) [ Time Frame: 9 or 24 months ] Quantified Muscular Testing (QMT) by hand grip and foot dorsiflexion dynamometry (mean of both sides

2016 Clinical Trials

155. Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging

: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Will be offered for study subjects that meet the following criteria: Man or woman hospitalized (e) in the aftermath of a IMV: History of at least 2 for the IMV group IMVr First suicide attempt high intentionality (SIS score> 20/30) for group IMVS Man or woman with alcohol dependence according to DSM-IV-TR, in the aftermath of withdrawal (outpatient or inpatient) for the alcohol group Man or woman free from any addictive disorder (...) psychotropic treatments (except anti-anxiety treatments benzodiazepine average duration of action and antihistamine), baclofen and other treatment can modify vasoreactivity fMRI. Coagulation disorders against-indicating blood. People under guardianship 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

2016 Clinical Trials

156. Treatment for Alcohol Dependence With Gabapentin

, relapsing disorder marked by compulsive alcohol use, an inability to stop drinking despite harmful consequences, and the emergence of a withdrawal syndrome upon cessation of use. Early abstinence is associated with activation of brain stress systems in the extended amygdala. Clinically, protracted abstinence involves symptoms of craving, mood and sleep disturbance, all of which have been identified as risk factors for relapse. Nonetheless, implementation of alcohol-specific medications remains limited (...) across most medical specialties. Medications for treating alcohol dependence primarily have been adjunctive interventions, and only three medications—disulfiram, naltrexone, and acamprosate—are approved for this indication by the United States Food and Drug Administration. Baclofen, an inhibitor of synaptic transmission through spinal reflex arcs via hyper polarization of primary afferent fiber terminals, was originally approved by the Food and Drug Administration in 1977 for use in spasticity

2016 Clinical Trials

157. A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment

(Pittsburgh Sleep Quality Index) during OL phase Treatment retention OL phase Safety will be assessed by evaluation of treatment emergent adverse events (TEAE), physical examinations, clinical laboratory tests (blood chemistry, hematology, and urinalysis), subsequent end of treatment potential withdrawal, evaluation scales and physical examination, measurement of heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at ECG Fridericia's corrected QT interval ≥ 500 ms or if difference (...) , Layout table for eligibility information Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus) Ages 18-65. Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale <10 at baseline assessment Normal weight: 18 kg/m2 ≤ BMI ≤ 35 kg/m2. Excessive alcohol use: number of heavy

2016 Clinical Trials

158. Evidence-based guideline: treatment of tardive syndromes: report of the Guideline Development Subcommittee of the American Academy of Neurology Full Text available with Trip Pro

Evidence-based guideline: treatment of tardive syndromes: report of the Guideline Development Subcommittee of the American Academy of Neurology To make evidence-based recommendations regarding management of tardive syndromes (TDS), including tardive dyskinesias (TDD), by addressing 5 questions: 1) Is withdrawal of dopamine receptor blocking agents (DRBAs) an effective TDS treatment? 2) Does switching from typical to atypical DRBAs reduce TDS symptoms? 3) What is the efficacy of pharmacologic (...) improve TDS but cannot be recommended as treatment because neuroleptics may cause TDS despite masking symptoms. Amantadine and tetrabenazine might be considered as TDS treatment (Level C). Diltiazem should not be considered as TDD treatment (Level B); galantamine and eicosapentaenoic acid may not be considered as treatment (Level C). Data are insufficient to support or refute use of acetazolamide, bromocriptine, thiamine, baclofen, vitamin E, vitamin B6, selegiline, clozapine, olanzapine, melatonin

2013 EvidenceUpdates

159. A Clinical Trial on the Efficacy of tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients (REDSTIM)

level according to World health Organization (WHO) in the 4 weeks before screening (WHO, 2000; ≤40g/day for men; ≤20g/day for women), Patients who refused to sign "safety" agreement Breath-alcohol concentration > 0 milligrams per litre of exhaled air at randomization (visit 1) More than 3-days abstinence prior to screening and randomization (screening visit and visit 1) Concomitant treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, and nalmefene History of pre-delirium tremens (...) and delirium tremens A Revised Clinical Institute Withdrawal Assessment for Alcohol score ≥ 10 (indicating the need for medication supported detoxification) at randomization (visit 1) History of epilepsy DSM-5 substance use disorder other than alcohol or nicotine use disorder Acute psychiatric disorders that have required hospitalisation and/or immediate adjustment of psychotropic medications Major depression, as defined by Hamilton Depression (HAM-D) scale greater than or equal to 17 Recent change

2015 Clinical Trials

160. Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)

1 Drug: PXT3003 dose 2 Drug: placebo Phase 3 Detailed Description: PXT3003, is a fixed dose combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol selected via a Systems Biology approach and developed by Pharnext, with the aim to lower toxic PMP22 gene over-expression in CMT1A. On September 18th 2017, the PXT3003 dose 2 was prematurely discontinued, due to an unexpected investigational medicinal product quality event (failed month 18 stability testing). The independent data safety (...) of treatment ] Incidence of Treatment Emergent Adverse Events (TEAE), of related TEAE with moderate or severe intensity, AE leading to withdrawal of study drug, and Serious Adverse Events, Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff

2015 Clinical Trials

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