Randomized trials of medications for alcohol dependence (AD) often report no differences between active medications. Few studies in AD have tested hypotheses regarding which medication will work best for which patients (ie, precision medicine). The PREDICT study tested acamprosate and naltrexone vs placebo in 426 randomly assigned AD patients in a 3-month treatment. PREDICT proposed individuals whose drinking was driven by positive reinforcement (ie, reward drinkers) would have a better treatment response to naltrexone, whereas individuals whose drinking was driven by negative reinforcement (ie, relief drinkers) would have a better treatment response to acamprosate. The goal of the current analysis was to test this precision medicine hypothesis of the PREDICT study via analyses of subgroups. Results indicated that four phenotypes could be derived using the Inventory of Drinking Situations, a 30-item self-report questionnaire. These were high reward/high relief, high reward/low relief, low reward/high relief, and low reward/low relief phenotypes. Construct validation analyses provided strong support for the validity of these phenotypes. The subgroup of individuals who were predominantly reward drinkers and received naltrexone vs placebo had an 83% reduction in the likelihood of any heavy drinking (large effect size). Cutoff analyses were done for clinical applicability: individuals are reward drinkers and respond to naltrexone if their reward score was higher than their relief score AND their reward score was between 12 and 31. Using naltrexone with individuals who are predominantly reward drinkers produces significantly higher effect sizes than prescribing the medication to a more heterogeneous sample.
Internet and computer game addiction represent a growing mental health concern, acknowledged by the World Health Organization.OBJECTIVE To determine whether manualized cognitive behavioral therapy (CBT), using short-term treatment for internet and computer game addiction (STICA), is efficient in individuals experiencing internet and computer game addiction. DESIGN, SETTING, AND PARTICIPANTSA multicenter randomized clinical trial was conducted in 4 outpatient clinics in Germany and Austria from January 24, 2012, to June 14, 2017, including follow-ups. Blinded measurements were conducted. A consecutive sample of 143 men was randomized to the treatment group (STICA; n = 72) or wait-list control (WLC) group (n = 71). Main inclusion criteria were male sex and internet addiction as the primary diagnosis. The STICA group had an additional 6-month follow-up (n = 36). Data were analyzed from November 2018 to March 2019. INTERVENTIONSThe manualized CBT program aimed to recover functional internet use. The program consisted of 15 weekly group and up to 8 two-week individual sessions. MAIN OUTCOMES AND MEASURESThe predefined primary outcome was the Assessment of Internet and Computer Game Addiction Self-report (AICA-S). Secondary outcomes were self-reported internet addiction symptoms, time spent online on weekdays, psychosocial functioning, and depression.RESULTS A total of 143 men (mean [SD] age, 26.2 [7.8] years) were analyzed based on intent-to-treat analyses. Of these participants, 50 of 72 men (69.4%) in the STICA group showed remission vs 17 of 71 men (23.9%) in the WLC group. In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age. Compared with the WLC groups, effect sizes at treatment termination of STICA were d = 1.19 for AICA-S, d = 0.88 for time spent online on weekdays, d = 0.64 for psychosocial functioning, and d = 0.67 for depression. Fourteen adverse events and 8 serious adverse events occurred. A causal relationship with treatment was considered likely in 2 AEs, one in each group.CONCLUSIONS AND RELEVANCE Short-term treatment for internet and computer game addiction is a promising, manualized, short-term CBT for a broad range of internet addictions in multiple treatment centers. Further trials investigating the long-term efficacy of STICA and addressing specific groups and subgroups compared with active control conditions are required.
The lockdown restrictions due to the COVID-19 pandemic have led to increased stress levels and feelings of anxiety in the general population. Problematic usage of certain online applications is one frequent way to compensate for negative feelings and stress. The current study investigated changes of online media consumption during the lockdown in Germany. Gender and age specific differences in specific online activities were assessed. n = 3245 subjects participated in an online survey conducted between the 8th April and the 11th May 2020. Participants’ age ranged between 18 and >55 years. A considerably high percentage (71.4%) of participants reported increased online media consumption during the lockdown. Male participants were more likely to increase their consumption of gaming and erotic platforms, while female participants reported a higher increase in the engagement in social networks, information research, and video streaming than males. The findings revealed an increased usage of all online applications during the lockdown. For the clarification whether the increase might present a risk for elevated Internet-use disorders or can be regarded as a functional and time-limited phenomenon, further studies, assessing changes in these online activities after the end of the pandemic, are needed.
The results of placebo-controlled trials (RCTs) with acamprosate or naltrexone vary substantially. Those differences have been attributed to differing patient characteristics, recruitment strategies, treatment settings and remuneration systems. We tested these assumptions by comparing a new double-blind, placebo-controlled randomized trial conducted in Germany (called PREDICT Study) with data from the US COMBINE Study. PREDICT was designed according to the protocol of the COMBINE Study. A total of 426 alcohol-dependent patients were compared to 459 COMBINE Study patients corresponding to the treatment cells in PREDICT. All patients received acamprosate, naltrexone or placebo for 3 months (PREDICT) or 4 months (COMBINE). Biweekly manualized 'medical management' to enhance compliance was delivered in both studies. Time until the first occurrence of heavy drinking was the main outcome measure. PREDICT found neither acamprosate nor naltrexone to supply any additional benefit compared with placebo, which is at variance with a positive naltrexone effect being reported in the COMBINE Study. A secondary comparison between both studies showed better overall treatment outcomes in PREDICT, although these patients had been more severely affected than their COMBINE counterparts. The divergence in results may be attributable to basic differences in the treatment environments (such as in-patient pre-treatment versus primary outpatient care). We suggest that identically designed RCTs conducted in different parts of the world may help improve the external validity of RCTs. This approach could be called 'comparative efficacy research'.
Our data suggest that pregabalin is liable to be abused among individuals with opiate dependency syndrome Thus, vigilance and caution are called for when patients with a past or current opiate dependency are exposed to treatment with pregabalin.
<b><i>Background:</i></b> Similar to other countries, the government of Germany has implemented various restrictions of social life in March 2020 to slow the spread of COVID-19 pandemic. This results in millions of people being isolated for long periods, which may increase feelings of worry and anxiety. As the consumption of alcohol and tobacco is an often used dysfunctional strategy to cope with such feelings, these restrictions might cause an increase of consumption. Already at the beginning of the COVID-19 pandemic, the World Health Organization (WHO) warned that increased alcohol consumption during the lockdown can increase the prevalence of alcohol use disorders in the future. However, up to now little is known about the changes in alcohol-drinking behavior and tobacco smoking in the general population during the COVID-19 pandemic. <b><i>Methods:</i></b> To address this theme, we investigated the changes in alcohol and tobacco consumption in the German population aged between 18 and 80 years via an online survey. <b><i>Results:</i></b> In total, 3,245 persons participated in the survey; 35.5% of them reported an increase in drinking during the lockdown (42.9% did not change their drinking behavior, 21.3% drank less, and 0.3% started drinking). The odds of consuming more alcohol during lockdown were associated with middle age, higher subjective stress due to the COVID-19 pandemic, a lower agreement with the importance of the restrictions, and consuming alcohol more than once per week before the lockdown. Also, 45.8% of the participants increased their smoking during the lockdown. The odds of smoking more during lockdown were associated with higher subjective stress due to the COVID-19 pandemic. <b><i>Conclusion:</i></b> These findings suggest that it is important to start campaigns to inform the general population about potential long-term effects of increased alcohol and tobacco consumption and to raise the health-care professionals’ awareness of this topic.
fMRI has the potential for predicting treatment response to naltrexone in a subgroup of alcohol-dependent patients. However, this approach will be limited to researching the mechanisms and principles of treatment response.
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