scholarly journals Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers

2021 ◽  
Vol 12 ◽  
Author(s):  
Alix Morel ◽  
Pierre Lebard ◽  
Alexandra Dereux ◽  
Julien Azuar ◽  
Frank Questel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Substance Use ◽  
Substance Use Disorders ◽  
Outcome Measures ◽  
Randomized Clinical Trials ◽  
Cochrane Library ◽  
Surrogate Endpoints ◽  
Opioid Use ◽  
Short Term ◽  
Drug Induced

Background: Cannabidiol (CBD) is a cannabinoid of potential interest for the treatment of substance use disorders. Our aim was to review the outcome measures, surrogate endpoints, and biomarkers in published and ongoing randomized clinical trials.Methods: We conducted a search in PubMed, Web of Science, PMC, PsycINFO, EMBASE, CENTRAL Cochrane Library, “clinicalTrials.gov,” “clinicaltrialsregister.eu,” and “anzctr.org.au” for published and ongoing studies. Inclusion criteria were randomized clinical trials (RCTs) examining the use of CBD alone or in association with other cannabinoids, in all substance use disorders. The included studies were analyzed in detail and their qualities assessed by a standardized tool (CONSORT 2010). A short description of excluded studies, consisting in controlled short-term or single administration in non-treatment-seeking drug users, is provided.Findings: The screening retrieved 207 published studies, including only 3 RCTs in cannabis use disorder. Furthermore, 12 excluded studies in cannabis, tobacco, and opioid use disorders are described.Interpretation: Primary outcomes were validated withdrawal symptoms scales and drug use reduction in the three RCTs. In the short-term or crossover studies, the outcome measures were visual analog scales for subjective states; self-rated scales for withdrawal, craving, anxiety, or psychotomimetic symptoms; and laboratory tasks of drug-induced craving, effort expenditure, attentional bias for substance, impulsivity, or anxiety to serve as surrogate endpoints for treatment efficacy. Of note, ongoing studies are now adding peripheral biomarkers of the endocannabinoid system status to predict treatment response.Conclusion: The outcome measures and biomarkers assessed in the ongoing CBD trials for substance use disorders are improving.

scholarly journals Effectiveness of non-pharmacological conservative therapies in adults with fibromyalgia: A systematic review of high-quality clinical trials

2021 ◽  
pp. 1-18
Author(s):  
Ignacio Hernando Garijo ◽  
Sandra Jiménez del Barrio ◽  
Teresa Mingo Gómez ◽  
Ricardo Medrano de la Fuente ◽  
Luis Ceballos Laita
Keyword(s):  
Clinical Trials ◽  
Pain Intensity ◽  
Physical Function ◽  
Strong Evidence ◽  
Randomized Clinical Trials ◽  
Cochrane Library ◽  
Short Term ◽  
High Quality ◽  
Positive Effects

BACKGROUND: Fibromyalgia is a chronic condition characterized by generalized pain. Several studies have been conducted to assess the effects of non-pharmacological conservative therapies in fibromyalgia. OBJECTIVE: To systematically review the effects of non-pharmacological conservative therapies in fibromyalgia patients. METHODS: We searched MEDLINE, Cochrane library, Scopus and PEDro databases for randomized clinical trials related to non-pharmacological conservative therapies in adults with fibromyalgia. The PEDro scale was used for the methodological quality assessment. High-quality trials with a minimum score of 7 out of 10 were included. Outcome measures were pain intensity, pressure pain threshold, physical function, disability, sleep, fatigue and psychological distress. RESULTS: Forty-six studies met the inclusion criteria. There was strong evidence about the next aspects. Combined exercise, aquatic exercise and other active therapies improved pain intensity, disability and physical function in the short term. Multimodal therapies reduced pain intensity in the short term, as well as disability in the short, medium and long term. Manual therapy, needling therapies and patient education provided benefits in the short term. CONCLUSIONS: Strong evidence showed positive effects of non-pharmacological conservative therapies in the short term in fibromyalgia patients. Multimodal conservative therapies also could provide benefits in the medium and long term.

Liraglutide for the Treatment of Obesity: Analyzing Published Reviews

2019 ◽  
Vol 25 (15) ◽  
pp. 1783-1790 ◽  
Author(s):  
Rosario Pastor ◽  
Josep A. Tur
Keyword(s):  
Weight Loss ◽  
Clinical Trials ◽  
Systematic Reviews ◽  
Randomized Clinical Trials ◽  
Statistical Tests ◽  
Overweight And Obesity ◽  
Cochrane Library ◽  
Medical Subject Headings ◽  
Mesh Terms ◽  
Treatment Of Obesity

Background: Several drugs have been currently approved for the treatment of obesity. The pharmacokinetic of liraglutide, as well as the treatment of type 2 diabetes mellitus, have been widely described. Objective: To analyze the published systematic reviews on the use of liraglutide for the treatment of obesity. Methods: Systematic reviews were found out through MEDLINE searches, through EBSCO host and the Cochrane Library based on the following terms: "liraglutide" as major term and using the following Medical Subject Headings (MesH) terms: "obesity", "overweight", "weight loss". A total of 3 systematic reviews were finally included to be analyzed. Results: From the three systematic reviews selected, only two included the randomized clinical trials, while the third study reviewed both randomized and non-randomized clinical trials. Only one review performed statistical tests of heterogeneity and a meta-analysis, combining the results of individual studies. Another review showed the results of individual studies with odds ratio and confidence interval, but a second one just showed the means and confidence intervals. In all studies, weight loss was registered in persons treated with liraglutide in a dose dependent form, reaching a plateau at 3.0 mg dose, which was reached just in men. Most usual adverse events were gastrointestinal. Conclusion: More powerful and prospective studies are needed to assess all aspects related to liraglutide in the overweight and obesity treatment.

scholarly journals Pelvic-Floor Dysfunction Prevention in Prepartum and Postpartum Periods

Medicina ◽  
2021 ◽  
Vol 57 (4) ◽  
pp. 387
Author(s):  
Karolina Eva Romeikienė ◽  
Daiva Bartkevičienė
Keyword(s):  
Clinical Trials ◽  
Pelvic Organ Prolapse ◽  
Pelvic Floor ◽  
Randomized Clinical Trials ◽  
Pelvic Floor Muscle Training ◽  
Pelvic Floor Muscle ◽  
Pelvic Floor Dysfunction ◽  
Pelvic Organ ◽  
Cochrane Library ◽  
Muscle Training

Every woman needs to know about the importance of the function of pelvic-floor muscles and pelvic organ prolapse prevention, especially pregnant women because parity and labor are the factors which have the biggest influence on having pelvic organ prolapse in the future. In this article, we searched for methods of training and rehabilitation in prepartum and postpartum periods and their effectiveness. The search for publications in English was made in two databases during the period from August 2020 to October 2020 in Cochrane Library and PubMed. 77 articles were left in total after selection—9 systematic reviews and 68 clinical trials. Existing full-text papers were reviewed after this selection. Unfinished randomized clinical trials, those which were designed as strategies for national health systems, and those which were not pelvic-floor muscle-training-specified were excluded after this step. Most trials were high to moderate overall risk of bias. Many of reviews had low quality of evidence. Despite clinical heterogeneity among the clinical trials, pelvic-floor muscle training shows promising results. Most of the studies demonstrate the positive effect of pelvic-floor muscle training in prepartum and postpartum periods on pelvic-floor dysfunction prevention, in particular in urinary incontinence symptoms. However more high-quality, standardized, long-follow-up-period studies are needed.

Clinical trials and American Indians/Alaska Natives with substance use disorders: identifying potential strategies for a new cultural-based intervention

2014 ◽  
Vol 13 (4) ◽  
pp. 175-178 ◽  
Author(s):  
Daniel L. Dickerson ◽  
Kamilla L. Venner ◽  
Bonnie Duran
Keyword(s):  
Clinical Trial ◽  
Substance Abuse ◽  
Clinical Trials ◽  
Substance Use ◽  
Focus Groups ◽  
Substance Use Disorders ◽  
American Indians ◽  
Alaska Natives ◽  
Treatment Setting ◽  
Content Type

Purpose – The purpose of this paper is to address a significant public mental health disparity affecting American Indians/Alaska Natives (AI/ANs): the shortage of clinical trials research analyzing the benefits of AI/AN traditional-based treatments, e.g. drumming. Design/methodology/approach – A total of four focus groups were conducted among outpatient and inpatient AI/AN substance abuse patients and providers serving AI/ANs. The purpose of these focus groups was to obtain insights relating to the recent challenges of conducting a clinical trial within the outpatient treatment setting seeking to analyze the benefits of a new substance abuse treatment intervention utilizing drumming for AI/ANs [Drum-assisted Recovery Therapy for Native Americans (DARTNA)] and to obtain recommendations to successfully conduct a similar study within an inpatient treatment setting. Findings – The most prevalent barriers to conducting a clinical trial within an outpatient setting were transportation and child care issues. Recommendations were obtained with regard to optimizing recruitment and retention for a future study within an inpatient setting. Originality/value – This research offers the field rare information that helps toward identifying strategies to successfully conduct clinical trials investigating the benefits of culturally-appropriate treatments for AI/ANs with substance use disorders.

Adverse events among adult Medicaid enrollees with opioid use disorder and co-occurring substance use disorders

2021 ◽  
Vol 221 ◽  
pp. 108555
Author(s):  
Peggy O’Brien ◽  
Rachel Mosher Henke ◽  
Mary Beth Schaefer ◽  
Janice Lin ◽  
Timothy B. Creedon
Keyword(s):  
Substance Use ◽  
Adverse Events ◽  
Substance Use Disorders ◽  
Opioid Use Disorder ◽  
Opioid Use

Abstract 228: National Prevalence of Substance Use Disorders Among Hospitalized Heart Failure Patients

2018 ◽  
Vol 11 (suppl_1) ◽  
Author(s):  
Sarah C Snow ◽  
Gregg C Fonarow ◽  
Joseph A Ladapo ◽  
Donna L Washington ◽  
Katherine Hoggatt ◽  
...  
Keyword(s):  
Heart Failure ◽  
Substance Use ◽  
Native American ◽  
Drug Use ◽  
Substance Use Disorders ◽  
Age Groups ◽  
Opioid Use ◽  
Drug Use Disorders ◽  
Increased Risk ◽  
Drug Use Disorder

Background: Several cardiotoxic substances contribute to the development of heart failure (HF). The burden of comorbid substance use disorders (SUD) among patients with HF is under-characterized. Objectives: To describe the national burden of comorbid SUD (tobacco, alcohol, or drug use disorders) among hospitalized HF patients in the U.S. Methods: We used data from the 2014 National Inpatient Sample to calculate the proportion of hospitalizations for a primary HF admission with tobacco, alcohol, or drug use disorder diagnoses, accounting for demographic factors. Drug use disorder analysis was further sub-divided into specific illicit substance categories. Results: There were a total of 989,080 HF hospitalizations of which 35.3% (n=348,995) had a documented SUD. Tobacco use disorder (TUD) was most common (n= 327,220, 33.1%) followed by drug use disorder (DUD) (n=34,600, 3.5%) and alcohol use disorder (AUD) (n=34,285, 3.5%). Female sex was associated with less TUD (OR 0.59; 95% CI, 0.58-0.60), AUD (OR 0.23; 95% CI, 0.22-0.25) or DUD (OR 0.58; 95% CI 0.55-0.62). Tobacco, alcohol, cocaine, and opioid use disorders were highest among HF patients age 45 to 55, while cannabis and amphetamine use was highest in those <45 years. Native American race (versus White) was associated with increased risk of AUD (OR 1.67; 95% CI 1.27-2.20). Black race was associated with increased risk of AUD (OR 1.09; 95% CI 1.02-1.16) or DUD (OR 1.63; 95% CI 1.53-1.74). Medicaid insurance (versus Medicare) was associated with greater TUD (OR 1.27; 95% CI 1.23-1.32), AUD (OR 1.74; 95% CI 1.62-1.87), and DUD (OR 2.15; 95% CI 2.01-2.30). Decreasing quartiles of median household income were associated with increasing SUD. Conclusions: Comorbid SUD disproportionately affects certain HF populations, including men, younger age groups, lower SES patients, and race/ethnic minorities. Further research on interventions to improve prevention and treatment of SUD among hospitalized HF patients are needed given the high rates of SUD in this population. Systematically screening hospitalized HF patients for SUD may reveal opportunities for treatment and secondary prevention.

Abstract P391: Marine N-3 Fatty Acids Reduce Atherosclerosis Cardiovascular Disease: A Systemic Review and Meta-analysis of Clinical Trials

Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Akira Sekikawa ◽  
Nobutake Hirooka ◽  
Abhishek Vishnu ◽  
Vashudha Ahuja ◽  
Emmanuel Sampene ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Fatty Acids ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Imaging Techniques ◽  
Meta Analysis ◽  
Quantitative Information ◽  
Systemic Review ◽  
Cochrane Library ◽  
Cardiac Imaging Techniques

Introduction: Although marine n-3 fatty acids are believed to be cardioprotective through their anti-arrhythmic, anti-thrombotic, anti-atherogenic and other effects, results from recent meta-analyses of marine n-3 fatty acids on cardiovascular disease (CVD) are controversial. We performed a meta-analysis of marine n-3 fatty acids on CVD outcomes in randomized clinical trials (RCTs) to test the hypothesis that marine n-3 fatty acids are anti-atherogenic. We also tested the hypothesis that such benefit is dose-dependent. Methods: A systematic review of English language articles using PubMed, EMBASE and Cochrane Library through Aug 2012 was performed selecting RCTs evaluating the effect of marine n-3 fatty acids intake for 2 years or more on cardiovascular diseases, coronary disease, arteriosclerosis, cardiac imaging techniques, and carotid artery ultrasound. Descriptive and quantitative information was extracted. Odds ratios were calculated for cardiac event outcome. Correlation coefficients were obtained from studies of which outcome is intima-media thickness (IMT) and coronary lumen diameter (CD). We converted the estimates into a single effect size; the log odds ratio and its corresponding standard error. Results: Of 14,236 citations retrieved, 13 studies were selected, including studies reporting IMT (n=3) and CD (n=2) and major CVD events (n=8). Overall, marine n-3 fatty acids significantly reduced atherosclerotic CVD (RR 0.94: 95%CI 0.90 to 0.99, p<0.05). There was no evidence of heterogeneity (p=0.65) or publication bias (p=0.37, Begg’s test). A sub-analysis among 8 studies of major CVD events showed the similar results (RR 0.94: 95% CI 0.89 to 0.99, p<0.05). Another sub-analysis among 4 studies excluding sudden cardiac death as an outcome showed RR of 0.91 (95% CI 0.82 to 1.02, p=0.097). A meta-regression analysis shows that dose of marine n-3 fatty acids was inversely associated with CVD outcome, although the association was not statistically significant (p=0.06). Conclusions: The result of our meta-analysis supports a modest anti-atherogenic effect of marine n-3 fatty acids. This benefit may be proportional to the amount of marine n-3 fatty acids consumed.

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