Psychopharmacological Treatments for Substance Use Disorders

2007 ◽  
pp. 145-178 ◽  
Author(s):  
Charles P. O’Brien ◽  
James McKay
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Methadone Maintenance ◽  
Abstinence Rate ◽  
Opiate Addiction ◽  
Blood Levels ◽  
Controlled Trials ◽  
Pharmacological Agents ◽  
Improve Compliance ◽  
Reduced Drinking

The treatment of substance abuse with pharmacological agents is well established, although most experts agree that, to be successful, medication interventions must be combined with psychosocial therapies. A large number of Type 1 and Type 2 controlled trials have shown that the use of nicotine replacement therapy to induce and maintain smoking cessations significantly increases the abstinence rate. Bupropion, which is also an antidepressant, has been found in controlled trials to significantly increase the smoking abstinence rate measured at intervals up to 12 months after beginning of treatment. Trials with novel agents such as the cannabinoid receptor antagonist rimonabant and varenicline, a nicotine receptor partial agonist, have been reported at meetings but have not yet appeared in print. The treatment of alcoholism can now be enhanced by three totally different types of medications: disulfiram, which works when compliance is assured; naltrexone, which reduces alcohol reward via the endogenous opioid system and results in decreased alcohol craving and reduced drinking in most randomized clinical trials; and acamprosate, which reduces post-alcohol excitability and has been effective in European trials but less so in U.S. trials. A depot version of the opiate antagonist naltrexone was approved by the FDA in 2006. It gives therapeutic blood levels for at least 30 days and should greatly improve compliance, thus making naltrexone more useful for the treatment of both opiate addiction and alcoholism. Methadone maintenance treatment for heroin dependence has consistently shown efficacy, and the treatment options have been increased by the availability of the partial opiate agonist buprenorphine. Buprenorphine is unique in that it can be used for the treatment of opiate addiction by qualified physicians in their offices rather than requiring enrollment in a highly regulated methadone treatment program. There are as yet no FDA-approved medications for the treatment of stimulant addiction, which includes cocaine and methamphetamine. There are recent double-blind, placebo-controlled clinical trials of several medications that have been found effective against cocaine addiction and are currently in multisite trials to confirm efficacy.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

scholarly journals Anti-Tumor Activity and Safety of Multikinase Inhibitors in Advanced and/or Metastatic Thyroid Cancer: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 52 (01) ◽  
pp. 25-31 ◽  
Author(s):  
Marina Tsoli ◽  
Krystallenia I. Alexandraki ◽  
Maria-Eleni Spei ◽  
Gregory A. Kaltsas ◽  
Kosmas Daskalakis
Keyword(s):  
Clinical Trials ◽  
Thyroid Cancer ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Objective Response ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Multikinase Inhibitors ◽  
Metastatic Thyroid Cancer

AbstractMany trials have demonstrated prime antitumor activity of novel, small molecule multikinase inhibitors (MKIs) in advanced and/or metastatic thyroid cancer (TC). In this work, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, SCOPUS, and clinicaltrials.gov databases were searched. Quality/risk of bias were assessed using GRADE criteria. Randomized clinical trials (RCTs) comparing two or more systemic therapies in patients with advanced and/or metastatic thyroid cancer were assessed. A total of 1347 articles and 548 clinical trials in clinicaltrials.gov were screened. We included seven relevant RCTs comprising 1934 unique patients assigned to different MKIs. Two separate network meta-analyses included four RCTs in radioiodine refractory well-differentiated thyroid cancer (RR-WDTC) and three RCTs in medullary thyroid cancer (MTC), respectively; all with a low risk of bias. We identified three therapies for RR-WDTC: sorafenib [disease control rate (DCR) odds ratio (OR): 0.11 (95% CI: 0.03–0.40); progression-free survival (PFS) hazard ratio (HR): 1.99 (95% CI: 1.62–2.46)], vandetanib [DCR_OR:0.26 (95% CI: 0.06–1.24); PFS_HR: 0.99 (95% CI: 0.82–1.20)] and lenvatinib [DCR_OR: 0.26 (95% CI: 0.05–1.33); PFS_HR: 0.99 (95% CI: 0.81–1.22)]; and the following therapies for MTC: vandetanib 300 mg [objective response rate (ORR)_OR: 3.31 (95% CI: 0.68–16.22); vandetanib 150 mg ORR_OR: 0.60 (95% CI: 0.16–2.33)]; and cabozantinib [ORR_OR: 85.32 (95% CI: 5.22–1395.15)]. Serious side effect (SE) analysis per organ/system demonstrated a varying MKI SE profile across both RR-WDTC and MTC diagnoses, more commonly involving metabolic/nutritional disorders [OR: 2.07 [95% CI: 0.82–5.18)] and gastrointestinal SE [OR: 1.63 (95% CI: 1.0–2.66)]. This network meta-analysis on advanced and/or metastatic TC points towards a higher efficacy of lenvatinib in RR-WDTC. The included MKIs exhibit a varying SE profile across different organs/systems favoring a patient-tailored approach with the anticipated toxicities guiding clinicians’ decisions.

scholarly journals Herbal Formula Modified Buzhong-Yiqi-Tang for Functional Constipation in Adults: A Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Hanlin Gong ◽  
Feng Qin ◽  
Hongbo He
Keyword(s):  
Clinical Trials ◽  
Therapeutic Effect ◽  
Randomized Clinical Trials ◽  
Functional Constipation ◽  
Adult Patients ◽  
Controlled Trials ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Prokinetic Agents

Background. Herbal formula Modified Buzhong-Yiqi-Tang (MBYT) has been widely used for the treatment of functional constipation in East Asia, but its efficacy and safety are unclear. Methods. The study was to evaluate the efficacy and safety of MBYT for adult patients with functional constipation. Randomized clinical trials were selected according to predefined inclusion and exclusion criteria. Results. In total, twenty-five randomized controlled clinical trials were included with 2089 patients. There was evidence that MBYT treatment significantly improved the symptoms of functional constipation compared with stimulant laxatives, osmotic laxatives, and prokinetic agents. Our results also demonstrated that, when used as an adjuvant therapy, MBYT significantly improved the symptoms of functional constipation, when compared with osmotic laxatives alone, prokinetic agents alone, and biofeedback alone. Moreover, patients taking MBYT experienced fewer adverse events compared to the control groups. Conclusion. This review suggests that MBYT appears to have excellent therapeutic effect on adult patients with functional constipation and no serious side effects were identified. However, due to overall limited quality, the therapeutic benefit of MBYT may be substantiated to a limited degree. Better methodological quality and large controlled trials are expected to further quantify the therapeutic effect of MBYT.

scholarly journals Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Hui-ru Jiang ◽  
Shuang Ni ◽  
Jin-long Li ◽  
Miao-miao Liu ◽  
Ji Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled ◽  
Central Register

The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21]), SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]), and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]). All trials did not report adverse events. These results were limited by the methodological flaws of trials.

Randomized Controlled Trials in the Evaluation of Antenatal Care

1992 ◽  
Vol 8 (S1) ◽  
pp. 40-45 ◽  
Author(s):  
Murray W. Enkin
Keyword(s):  
Clinical Trials ◽  
Antenatal Care ◽  
Randomized Controlled Trials ◽  
Perinatal Outcome ◽  
Randomized Clinical Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Adverse Perinatal Outcome ◽  
Randomized Controlled

AbstractMany of the practices carried out during antenatal care improve the well-being of mother or baby and reduce the burden of adverse perinatal outcome. Other practices have either not been evaluated or have been shown to be ineffective. Evidence from randomized clinical trials provides the best evidence about the effectiveness of these practices.

scholarly journals Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

2020 ◽  
Author(s):  
Joseph A. Ladapo ◽  
John E. McKinnon ◽  
Peter A. McCullough ◽  
Harvey Risch
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Exposure Prophylaxis

Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

scholarly journals Dental Composite Restorations Repair: A Systematic Review and Meta-analysis

2021 ◽  
pp. 707-738
Author(s):  
Abdulmohsen Al Rabiah ◽  
Alamri Zahrah ◽  
Tuwaym Malath ◽  
Al Daghri Ebtihal ◽  
Al Suhaibani Daniyah ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Prospective Cohort ◽  
Randomized Clinical Trials ◽  
Assessment Tool ◽  
Risk Of Bias ◽  
Dental Composite ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Bias Assessment

Background: Controversy exists in the literature regarding the most optimal repair procedure for improving the adhesion between the repair resin and the existing resin composite materials. Hence the aim of the present study was to do a systematic review and to analyze the adhesion potential of resin-based composites to similar and dissimilar composites and aimed to determine the possible dominant factors affecting the bond strength results. Materials & Methods: Randomized clinical trials (RCTs) and prospective cohort design were searched through electronic databases including MEDLINE, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials for randomized clinical trials (RCTs) until July 2020 that compared different methods of composite restoration repair and a minimum mean follow-up time of 1 year. There were no restrictions on a particular treatment indication or outcome measures. Two authors independently conducted screening, risk of bias assessment, and data extraction of eligible trials in duplicate. We applied the Cochrane risk of bias assessment tool to consider the risk of bias. Results: We identified 10 articles; two of them were RCTs, and eight prospective cohort studies. There were 530 participants, with 990 teeth, dealing with resin-based composite (RBC) restorations. The intervention of defective restorations ranged from minimal intervention to total restoration replacement. The evaluation criteria were also varied with different evaluation protocols. The low number and heterogeneity of RCTs did not allow for meta-analyses. Conclusions: Although different repair protocols are mentioned in the literature according to the included studies, an appropriate and definitive conclusion can't be drawn. However, it seems repairs versus replacements should be considered as the first line of treatment when all factors lead to repair rather than replacement. Further randomized controlled trials with high methodological quality need to be conducted in order to establish evidence-based recommendations, particularly for RBC repair.

scholarly journals Evaluating Anti-infective Drugs in the Resistant Pathogen Setting: Can We Use External Controls?

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Scott R Evans ◽  
John Powers
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
Patient Characteristics ◽  
Controlled Trials ◽  
Advantages And Disadvantages ◽  
Lack Of Information ◽  
Study Results ◽  
New Treatments ◽  
The Impact

AbstractDecreased efficacy of antibiotics due to resistant pathogens has created a need for the development of more effective medical interventions. Despite the increasing prevalence of pathogens resistant to one or more drugs, identifying and enrolling participants into clinical trials that evaluate new interventions for the treatment of some diseases can be challenging given the low prevalence of disease in which there are no effective treatments. Thus researchers might be tempted to consider externally-controlled trials that may allow for a reduction of the necessary number of prospectively-identified trial participants, thus easing recruitment burden and resulting in more timely trial completion relative to randomized controlled trials. We discuss advantages and disadvantages in externally controlled trials and review requirements for a valid externally-controlled trial. As ECTs are subject to the bias of observational studies, the criteria for a valid ECT should be carefully evaluated before these designs are implemented. Given considerable variation in study results in the resistant pathogen setting, the lack of information on important patient characteristics that may confound estimates of treatment effects, as well as the improvements in medical practice and evolving antibiotic resistance, the use of ECTs in the resistant pathogen setting, is not recommended. ECTs should be should be limited to specific situations where superiority of the effect of the new intervention is dramatic, the usual course of the disease highly predictable, the endpoints are objective (e. g., all-cause mortality) and the impact of baseline and treatment variables on outcomes is well characterized. Given that the resistant pathogen setting does not satisfy these criteria, we conclude that that randomized clinical trials are needed to evaluate new treatments for resistant pathogens. Innovative approaches to trial design that may ease recruitment burden while evaluating the benefits and harms of new treatments are being developed and utilized.

Efficacy of Coenzyme Q10 for Improved Tolerability of Cancer Treatments: A Systematic Review

2004 ◽  
Vol 22 (21) ◽  
pp. 4418-4424 ◽  
Author(s):  
Liz Roffe ◽  
Katja Schmidt ◽  
Edzard Ernst
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Coenzyme Q10 ◽  
Randomized Clinical Trials ◽  
Liver Toxicity ◽  
Controlled Trials ◽  
Controlled Clinical Trials ◽  
Cancer Treatments ◽  
Oral Supplementation

Purpose The aim of this systematic review was to summarize and evaluate the evidence available for oral supplementation with coenzyme Q10 (CoQ10) to improve the tolerability of cancer treatments. Materials and Methods Searches for all published and unpublished controlled trials were carried out on seven databases. Manufacturers of CoQ10 were identified and contacted. Controlled clinical trials of monopreparations of CoQ10 administered orally to cancer patients were included. No language restrictions were imposed. Data were extracted independently by two authors according to predefined criteria. Results Six studies were included in the review, including three randomized clinical trials and three nonrandomized clinical trials. Patients in five of six studies received anthracyclines. The results suggested that CoQ10 provides some protection against cardiotoxicity or liver toxicity during cancer treatment. However, because of inadequate reporting and analysis, as well as questionable validity of outcome measures, the results are not conclusive. Conclusion Suggestions that CoQ10 might reduce the toxicity of cancer treatments have not been tested by rigorous trials. Further investigations are necessary to determine whether CoQ10 can improve the tolerability of cancer treatments.

Endpoints for Perianal Crohn’s Disease Trials: Past, Present and Future

2021 ◽  
Author(s):  
Bénédicte Caron ◽  
Ferdinando D’Amico ◽  
Silvio Danese ◽  
Laurent Peyrin-Biroulet
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Primary Endpoint ◽  
Randomized Clinical Trials ◽  
Controlled Trials ◽  
Perianal Crohn’S Disease ◽  
Perianal Crohn's Disease

Abstract Background and Aims Since the 1980s, many studies have evaluated the efficacy of therapies to improve the outcomes of patients with perianal Crohn’s disease. We performed a systematic review to describe the evolution of endpoints in perianal fistulizing Crohn’s disease. Efficacy outcomes, definitions and measurement tools were assessed. Methods Electronic databases were searched up to November 1, 2020. All published randomized placebo-controlled trials enrolling patients with perianal fistula and Crohn’s disease were eligible for inclusion. Ongoing randomized clinical trials were also described. Results Nineteen randomized controlled trials were included. Clinical efficacy endpoints were reported in all trials. Clinical response was the most frequent primary endpoint [6/19 studies, 31.6%], followed by clinical remission in four studies [21%]. Clinical response was defined as closure of at least 50% of fistulas, while remission was defined as closure of all fistulas. A combined clinical and radiological primary endpoint was used to assess fistula healing in four studies [21%]. The Perianal Disease Activity Index was a primary endpoint in only one study [5.5%]. In addition, eight ongoing controlled trials were identified. Combined clinical and radiological remission was the most frequent primary endpoint in these studies [4/8, 50%]. Conclusion In this systematic review, significant changes in outcomes used in randomized clinical trials of perianal Crohn’s disease were observed. Radiological endpoints are increasingly used in perianal fistulizing Crohn’s disease trials.

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