Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial.
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ABSTRACT:
SUBMITTER: Gendy MNS
PROVIDER: S-EPMC7250869 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature
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Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial.
Gendy Marie N S MNS Lagzdins Dina D Schaman Jessika J Le Foll Bernard B
Scientific reports 20200526 1
A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related s ...[more]
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Project description:The vast majority of individuals with alcohol use disorder (AUD) do not seek professional help despite its significant consequences upon the individual and society. Current interventions for nontreatment seeking individuals with AUD (e.g., screening, brief intervention, and referral to treatment [SBIRT]) have limited efficacy and alternative nonstigmatizing approaches are needed. This randomized clinical trial examined the utility of exercise as an intervention for sedentary nontreatment seeking adults with AUD. Participants (N = 66) were randomized to receive (a) a 4-month YMCA gym membership only (MO) or (b) a 4-month YMCA gym membership plus a 16-week integrated motivational intervention for exercise consisting of motivational interviewing and contingency management (MI + CM). Participants in both study conditions significantly increased their exercise behavior compared to baseline, and the MI + CM participants exercised significantly more often and an overall larger volume of exercise than the MO participants (ds > 2.0). Significant reductions in drinking and alcohol-related consequences were noted over time but did not differ significantly by study condition and were not related to changes in exercise. Future interventions using exercise as an intervention for AUD may want to frame this type of intervention as "wellness," directly link the 2 behaviors, and compare this intervention to SBIRT. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
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Project description:BackgroundAlcohol use disorder (AUD) has been associated with diverse physical and mental morbidities. Among the main consequences of chronic and excessive alcohol use are cognitive and executive deficits. Some of these deficits may be reversed in specific cognitive and executive domains with behavioral approaches consisting of cognitive training. The advent of computer-based interventions may leverage these improvements, but randomized controlled trials (RCTs) of digital interactive-based interventions are still scarce.ObjectiveThe aim of this study is to explore whether a cognitive training approach using VR exercises based on activities of daily living is feasible for improving the cognitive function of patients with AUD undergoing residential treatment, as well as to estimate the effect size for this intervention to power future definitive RCTs.MethodsThis study consisted of a two-arm pilot RCT with a sample of 36 individuals recovering from AUD in a therapeutic community; experimental group participants received a therapist-guided, VR-based cognitive training intervention combined with treatment as usual, and control group participants received treatment as usual without cognitive training. A comprehensive neuropsychological battery of tests was used both at pre- and postassessments, including measurement of global cognition, executive functions, attention, visual memory, and cognitive flexibility.ResultsIn order to control for potential effects of global cognition and executive functions at baseline, these domains were controlled for in the statistical analysis for each individual outcome. Results indicate intervention effects on attention in two out of five outcomes and on cognitive flexibility in two out of six outcomes, with effect sizes in significant comparisons being larger for attention than for cognitive flexibility. Patient retention in cognitive training was high, in line with previous studies.ConclusionsOverall, the data suggest that VR-based cognitive training results in specific contributions to improving attention ability and cognitive flexibility of patients recovering from AUD.Trial registrationClinicalTrials.gov NCT04505345; https://clinicaltrials.gov/show/NCT04505345.
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Project description:BackgroundTopiramate is an effective treatment for alcohol use disorder (AUD) and has also been used in the care of mild traumatic brain injury (mTBI). This pilot study aimed to obtain a preliminary assessment of topiramate's efficacy in reducing alcohol use and post-concussive symptoms, and its potential negative impact on cognitive function in 32 Veterans with co-occurring AUD and mTBI.MethodsThis was a prospective 12-week, randomized, double-blind, placebo-controlled pilot study of flexible-dose topiramate or placebo. Primary outcome was reduction of drinking days per week within the topiramate arm. Secondary outcomes included between group comparisons of alcohol use and craving, post-concussive symptoms, and cognitive function.ResultsDrinking days per week significantly decreased within both the topiramate and placebo arm. There were no significant treatment-by-week interactions on alcohol use/craving, or post-concussive symptoms in intent-to-treat analyses. In per-protocol analyses, topiramate significantly reduced number of drinks per week compared with placebo. Topiramate transiently impaired verbal fluency and working memory. Processing speed, cognitive inhibition, and mental flexibility significantly improved between weeks 1 and 12, regardless of treatment arm.ConclusionsSignificant improvement occurred in both the topiramate and placebo groups over 12 weeks of treatment in alcohol use and post-concussive symptoms. Among treatment completers there was greater reduction of alcohol use in the topiramate arm. Topiramate was also associated with negative but transient effects on cognitive function. Results suggest both a possible benefit for topiramate treatment in reducing alcohol use and some potential for negative cognitive effects in Veterans with AUD and mTBI.
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Project description:BackgroundAlcohol use disorder (AUD) is associated with cognitive deficits such as impaired executive functions, which are hypothesized to contribute to the progression of the disease and worsen treatment outcome. Training of working memory (WM) to improve cognitive functions and thereby reduce alcohol use has been proposed as a novel treatment strategy.MethodsPatients with AUD (n = 50) who were recruited to an outpatient addiction clinic were randomized to receive 5 weeks of active WM training or control training. Participants had weekly follow-up visits, and all cognitive training sessions were done online at home. Primary outcomes were WM function and change in self-reported heavy drinking. Secondary outcomes were craving, other drinking outcomes, and performance on a range of neuropsychological tasks from the Cambridge Neuropsychological Test Automated Battery.ResultsThe active training group demonstrated a significantly greater improvement in verbal WM compared with the control group. No statistically significant effect of training was found on the primary drinking outcome, but a trend was observed indicating that WM training reduces the number of drinks per drinking occasion. WM training had no statistically significant effect on any of the other neuropsychological tasks.ConclusionsCognitive training can improve WM function in individuals with AUD, suggesting that such interventions are feasible to administer in this patient population. The results do not support an effect of WM training on heavy drinking or transfer effects to other cognitive domains. Future studies should evaluate WM training as an adjunct to evidence-based treatments for AUD to assess potential synergistic effects.
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Project description:AimsTo examine whether physical activity as an adjunct to outpatient alcohol treatment has an effect on alcohol consumption following participation in an exercise intervention of six months' duration, and at 12 months after treatment initiation.MethodsThe study is a randomized controlled study with three arms: Patients allocated to (A) treatment as usual, (B) treatment as usual and supervised group exercise, (C) treatment as usual and individual physical exercise. The primary outcome measure was excessive drinking six months after treatment start and completion of the intervention. A logistic regression model was used to evaluate the odds of excessive drinking among the three groups, based on intention-to-treat. Changes in level of physical activity in all three groups were tested by using a generalized linear mixed model. A multiple linear model was used to test if there was an association between amount of performed physical activity and alcohol consumption.ResultsA total of 175 patients (68.6% male) participated. Response rates were 77.7% at six months and 57.1% at 12 months follow-up. OR 0.99 [95% CI: 0.46; 2.14], p = 0.976 for excessive drinking in the group exercise condition, and 1.02 [95% CI: 0.47; 2.18], p = 0.968 in the individual exercise condition, which, when compared to the control group as reference, did not differ statistically significantly. Participants with moderate level physical activity had lower odds for excessive drinking OR = 0.12 [0.05; 0.31], p<0.001 than participants with low level physical activity. Amount of alcohol consumption in the intervention groups decreased by 4% [95% CI: 0.03; 6.8], p = 0.015 for each increased exercising day.ConclusionsNo direct effect of physical exercise on drinking outcome was found. Moderate level physical activity was protective against excessive drinking following treatment. A dose-response effect of exercise on drinking outcome supports the need for implementing physically active lifestyles for patients in treatment for alcohol use disorder.
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Project description:BACKGROUND:Alcohol use is prevalent in many societies and has major adverse impacts on health, but the availability of effective interventions limits treatment options for those who want assistance in changing their patterns of alcohol use. OBJECTIVE:This study evaluated the new Daybreak program, which is accessible via mobile app and desktop and was developed by Hello Sunday Morning to support high-risk drinking individuals looking to change their relationship with alcohol. In particular, we compared the effect of adding online coaching via real-time chat messages (intervention group) to an otherwise self-guided program (control group). METHODS:We designed the intervention as a randomized control trial, but as some people (n=48; 11.9%) in the control group were able to use the online coaching, the main analysis comprised all participants. We collected online surveys at one-month and three-months follow-up. The primary outcome was change in alcohol risk (measured with the alcohol use disorders identification test-consumption [AUDIT-C] score), but other outcomes included the number of standard drinks per week, alcohol-related days out of role, psychological distress (Kessler-10), and quality of life (EUROHIS-QOL). Markers of engagement with the program included posts to the site and comments on the posts of others. The primary analysis used Weighted Generalized Estimating Equations. RESULTS:We recruited 398 people to the intervention group (50.2%) and 395 people to the control group (49.8%). Most were female (71%) and the mean age was 40.1 years. Most participants were classified as probably dependent (550, 69%) on the AUDIT-10, with 243 (31%) classified with hazardous or harmful consumption. We followed up with 334 (42.1%) participants at one month and 293 (36.9%) at three months. By three months there were significant improvements in AUDIT-C scores (down from mean 9.1 [SD 1.9] to 5.8 [SD 3.1]), alcohol consumed per week (down from mean 37.1 [SD 28.3] to mean 17.5 [SD 18.9]), days out of role (down from mean 1.6 [SD 3.6] to 0.5 [SD 1.6]), quality of life (up from 3.2 [SD 0.7] to 3.6 [SD 0.7]) and reduced distress (down from 24.8 [SD 7.0] to 19.0 [SD 6.6]). Accessing online coaching was not associated with improved outcomes, but engagement with the program (eg, posts and comments on the posts of others) were significantly associated with improvements (eg, in AUDIT-C, alcohol use and EUROHIS-QOL). Reduced alcohol use was found for both probably dependent (estimated marginal mean of 40.8 to 20.1 drinks) and hazardous or harmful alcohol users (estimated marginal mean of 22.9 to 11.9 drinks). CONCLUSIONS:Clinically significant reductions in alcohol use were found, as well as reduced alcohol risk (AUDIT-C) and days out of role. Importantly, improved alcohol-related outcomes were found for both hazardous or harmful and probably dependent drinkers. Since October 2016, Daybreak has reached more than 50,000 participants. Therefore, there is the potential for the program to have an impact on alcohol-related problems at a population health level, importantly including an effect on probably dependent drinkers. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry: ACTRN12618000010291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373110. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/9982.
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