scholarly journals Ethical and clinical safety considerations in the design of an effectiveness trial: A comparison of buprenorphine versus naltrexone treatment for opioid dependence

2016 ◽  
Vol 51 ◽  
pp. 34-43 ◽  
Author(s):  
Edward V. Nunes ◽  
Joshua D Lee ◽  
Dominic Sisti ◽  
Andrea Segal ◽  
Arthur Caplan ◽  
...  
2014 ◽  
Vol 21 (1) ◽  
pp. 86-90
Author(s):  
Robertas Badaras ◽  
Gabija Dragelytė ◽  
Indrė Vaitekonytė ◽  
Juozas Ivaškevičius ◽  
Jūratė Šipylaitė

Materials and Methods. Published articles on the opioid abuse and methods of opioid detoxification were identified by searching medical databases, using corresponding literature and were also searched manually for applicable papers. The search was limited to articles published from 1985 through 2014. Results. Opioid dependence determine pathophysiologic changes in the dopaminergic pathways of the organism, as well as the alterations in the stress-responsive hypothalamic-pituitary-adrenal axis. The usage of opioid antagonists in the early stages of withdrawal, can lead the effectiveness of opioid detoxification to 100%. Rapid opioid detoxification do not remove all the symptoms of abstinence. Negative aspects, concerning the procedure, while using prevention, can be reduced to the minimum risk. Rapid opioid detoxification, comparing it with Ultrarapid opioid detoxification procedure, diverges as less financial resources and a lower risk containing technique. Conclusions. Use of antagonists may reduce the duration of withdrawal, thus reducing the overall severity of withdrawal and increasing the chances of successful completion. This technique facilitates commencement of naltrexone treatment. Dosing regimens used in clinical trials vary. Subsequent results do not correlate with the methods of detoxification.


2011 ◽  
Vol 5 ◽  
pp. SART.S5452 ◽  
Author(s):  
Kimberly L. Kjome ◽  
F. Gerard Moeller

Opioid dependence is a condition with serious clinical ramifications. Treatment has focused on detoxification, agonist therapy with methadone or buprenorphine, or remission maintenance with the opioid antagonist, naltrexone. Treatment with oral naltrexone has been limited by poor treatment adherence and relapse. Studies with long-acting formulations have shown increased treatment adherence. Extended-release injectable naltrexone has been used for the treatment of alcohol dependence, and has recently received an indication for treatment of opioid dependence from the US Food and Drug Administration. Dosing occurs once monthly and existing data with long-acting naltrexone supports efficacy of treatment for opioid dependence; however published data is sparse. Treatment with long-acting naltrexone should be monitored for hepatotoxicity, and patients should be made aware of increased risk of overdose with administration of opioids during and immediately after discontinuation of long-acting naltrexone.


2009 ◽  
Vol 194 (6) ◽  
pp. 541-546 ◽  
Author(s):  
Nikolaj Kun⊘e ◽  
Philipp Lobmaier ◽  
John Kåre Vederhus ◽  
Bj⊘rg Hjerkinn ◽  
Solfrid Hegstad ◽  
...  

BackgroundNaltrexone has considerable potential in helping to prevent relapse in heroin dependency. A longer-lasting formulation for naltrexone treatment is desirable to further reduce non-adherence and relapse during treatment of opiate dependence.AimsTo evaluate the safety and effectiveness of a 6-month naltrexone implant in reducing opioid use after in-patient treatment.MethodA group of 56 abstinence-oriented patients who completed in-patient treatment for opioid dependence were randomly and openly assigned to receive either a 6-month naltrexone implant or their usual aftercare. Drug use and other outcomes were assessed at 6-month follow-up.ResultsPatients receiving naltrexone had on average 45 days less heroin use and 60 days less opioid use than controls in the 180-day period (both P<0.05). Blood tests showed naltrexone levels above 1 ng/ml for the duration of 6 months. Two patients died, neither of whom had received an implant.ConclusionsNaltrexone implant treatment safely and significantly reduces opioid use in a motivated population of patients.


Author(s):  
Mark Riehl

Transcranial magnetic stimulators have progressed from basic implementations to integrated systems optimized for treatment of pathologies. This article reviews key factors of design of such clinically targeted systems, discussing design principles, procedure-specific features, and clinical safety requirements. A power source, a capacitor, and a high-power switch controlled by a processor form the basic stimulator. The fundamental operating mechanism of a TMS stimulator is to create a changing magnetic field that can induce a current in adjacent conductive material. The clinical TMS system must incorporate patient positioning, patient comfort, coil positioning features, and intuitive user controls and means of managing patient data to be a fully effective system. The most important safety risk with repetitive TMS reported in the literature is the risk of inducing seizure. Other safety considerations include proper use of human factor analysis to minimize improper operation, the biocompatibility of materials touching the patient, and addressing acoustic noise.


2001 ◽  
Vol 58 (8) ◽  
pp. 755 ◽  
Author(s):  
Kathleen M. Carroll ◽  
Samuel A. Ball ◽  
Charla Nich ◽  
Patrick G. O'Connor ◽  
Dorothy A. Eagan ◽  
...  

2018 ◽  
Vol 25 (2) ◽  
pp. 139 ◽  
Author(s):  
E. Klimant ◽  
H. Wright ◽  
D. Rubin ◽  
D. Seely ◽  
M. Markman

This article reviews intravenous vitamin C (IV C) in cancer care and offers a rational approach to enable medical oncologists and integrative practitioners to safely provide IV C combined with oral vitamin C to patients. The use of IV C is a safe supportive intervention to decrease inflammation in the patient and to improve symptoms related to antioxidant deficiency, disease processes, and side effects of standard cancer treatments. A proposed rationale, together with relevant clinical safety considerations for the application of IV C in oncologic supportive care, is provided.


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