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Alcoholism clinical trials

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NCT ID: NCT04999371 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption

Start date: July 29, 2021
Phase: N/A
Study type: Interventional

The existing alcohol intervention studies are mainly conducted in developed countries, few studies have focused on alcohol consumption among ethnic minority migrant people in developing countries. To address this gap, the investigators aim to evaluate the effects of a brief intervention combined with a small financial incentive on alcohol consumption and health outcomes among the migrated population in Liangshan Prefecture. This study was conducted in Liangshan Prefecture for two reasons: first, Liangshan is a region located in the southwestern of Sichuan province and is populated by Yi minority, and the average income in Liangshan is just about two-thirds of the national average income. Second, a study found that the drinking rate of the Yi minority (47.9%) is higher than that of other regions in China. The aim of this paper is to provide an overview of alcohol consumption among the ethnic populations in China and to test the feasibility and efficacy of small financial incentives with brief advice intervention targeting the reduction of harmful drinking behaviors among poor people.

NCT ID: NCT04927455 Active, not recruiting - Alcoholism Clinical Trials

Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability

VITAE
Start date: April 16, 2021
Phase:
Study type: Observational

In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial. This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.

NCT ID: NCT04927364 Active, not recruiting - Clinical trials for Transcranial Magnetic Stimulation

Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with an alcohol use disorder (AUD).

NCT ID: NCT04822987 Active, not recruiting - Clinical trials for Cognitive Impairment

Factors Predicting Outcome in Group Treatment of Alcohol Use Disorders (AUDs)

Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

Harmful alcohol use is a global risk factor for disease, injuries and death. Research on treatment of Alcohol use disorders (AUDs) indicates that different treatment modalities are equally effective, but also that a large group of patients do not change their drinking pattern despite being in treatment. It is assumed that it is not random who benefits from treatment. Thirty to forty percent of outcome variance in treatment is probably explained by patient factors, and we need more knowledge on how different patient factors moderate treatment effects. Further, clinicians also need more knowledge about selecting patients to different therapies. The present study will investigate how patient factors predict outcome in group treatment of AUDs, and what predicts positive treatment outcomes over time. The study is designed as a quasi-experimental, multi-centre, follow-up study. Patients will be included from Vestfold Hospital Trust, Borgestadklinikken, Blue Cross Clinic, Behandlingssenteret Eina, Blue Cross Clinic and A-senteret, Oslo, Church City Mission. The Project will provide more knowledge about patients seeking treatment for AUDs, and specifically how patient factors predict outcome in group treatment. These results will in turn lead to better selection of treatment modalities, and patients will receive a more effective treatment earlier on. Main aims: 1) How do patient factors predict outcome in group treatment of alcohol use disorders (AUDs)? 2) Do positive treatment outcomes last over time? Specifically, do the following factors: a) psychiatric comorbidity b) severity of alcohol use pre-treatment c) personality disorders and d) cognitive impairments predict 1) completion of group treatment and 2) positive outcome after 1 year. As an additional aim, we will investigate if the Montreal Cognitive Assessment test (MoCa) is feasible as a brief screening instrument for mild cognitive impairments for AUD patients.

NCT ID: NCT04718792 Active, not recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Start date: February 9, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD.

NCT ID: NCT04618653 Active, not recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Comprehensive Process Model of AA-related Behavior Change

Start date: September 28, 2020
Phase:
Study type: Observational

Alcoholics Anonymous (AA) is one of the most popular resources for dealing with alcohol-related problems, and 12-step therapy (TS), based upon AA doctrine and practice, is one of the prevailing alcohol treatment approaches in the United States. Two large multisite trials, one high in internal validity and the second high in external validity came to the same conclusion, TS was equally effective as more research supported therapies, and may actually be superior when total abstinence is the treatment goal. A primary objective of TS is to facilitate AA affiliation and strong evidence suggests that this aim is a major factor accounting for the effectiveness of TS. High priority has therefore been assigned to the investigation of what actually occurs in AA, with a special focus on identifying prescribed AA behaviors and processes that are predictive of drinking reduction. The guiding assumption of these efforts is that the key to improve TS is to first understand AA better. To this end, this study will generate, for the first time, a comprehensive and definitive process model of AA-related behavior change. This objective will be realized through the highly innovative use of EMA data collection among early AA affiliates. Using real-time daily data, aim 1 will determine if four MOBC identified by AA researchers (gains in social support, increased abstinence self-efficacy, spiritual practices, and negative urgency) mediate the linkage between three types of AA prescribed behaviors and drinking outcome. Noteworthy, these analyses will include the first rigorous testing of six of seven of criteria to confirm (or reject) that these four statistical mediators are MOBC. Aim 2 will investigate whether the actions of the AA active ingredients on mediators (a path) and the actions of the mediators (b path) are constant over time or, alternatively, if there are critical periods of influence. Last, aim 3 will determine if the four MOBC operate differently across distinct subpopulations. To achieve study aims, we propose a two-group randomized longitudinal study (N = 190). In one group (n = 130) we will collect 6-months of continuous EMA data, allowing us to examine near real-time associations between AA active ingredients in three domains, four MOBC, and drinking. In tandem, we will also conduct in-person interviews at baseline, 3, and 6-months. Assessment reactivity is a concern, especially so because this will be the first study to use EMA in addition to in-person interviews in AA research. We will therefore include a traditional fixed assessment group (n = 60) also interviewed at baseline, 3, and 6-months to identify potential measurement biases introduced in our innovative approach. Achievement of study aims will generate the first empirically validated AA process model that will inform TS with critical information for improving treatment outcomes.

NCT ID: NCT04581603 Active, not recruiting - Clinical trials for Alcohol Use Disorder With Insomnia

CBT-I Augmentation of Medication for Drinking in AUD

Start date: June 15, 2022
Phase: Phase 4
Study type: Interventional

Alcohol Use Disorder (AUD) and insomnia are more prevalent in Veterans than in the general community. Furthermore, insomnia is comorbid in 36-91% of individuals with AUD and jeopardizes recovery by increasing their risk for relapse and complicating their clinical profile. The VA/DoD guidelines recommend four medications for the treatment of AUD by promoting abstinence and a reduction in drinking. Two of these medications (MED) used commonly are naltrexone and topiramate but they do not improve sleep continuity or insomnia. The recommended treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I), and it has shown efficacy in improving insomnia but with minimal benefit in improving abstinence. However, these studies have involved subjects in early or sustained remission. The proposed study will evaluate whether augmenting MED with CBT-I, after reducing drinking or achieving abstinence, bolsters recovery in AUD, by decreasing insomnia and improving abstinence. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of MED with CBT-I should be considered a standard component of the initial management of AUD with insomnia.

NCT ID: NCT04581499 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Tech-Enabled CM for AUD at Scale

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This Phase II Small Business Innovative Research (SBIR) project is a clinical effectiveness and cost-effectiveness random controlled trial (RCT) of DynamiCare Health's innovative smartphone/smart debit card remote digital coaching program, which integrates Contingency Management, Recovery Coaching, and cognitive behavioral therapy (CBT), to address alcohol use disorder (AUD) in 300 adults.

NCT ID: NCT04565899 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Improving Care for Unhealthy Alcohol Use in Primary Care

Start date: February 25, 2021
Phase: N/A
Study type: Interventional

In order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one VA primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . It is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to Veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).

NCT ID: NCT04565288 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are twofold. The first primary objective is to evaluate the feasibility, acceptability, and tolerability of atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) as compared to placebo for 6 weeks plus a psychosocial platform comprised of motivational enhancement therapy and cognitive behavioral therapy (MET-CBT) among adolescents (ages 14 to 19 years) with alcohol use disorder as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). The second primary objective is to leverage a human laboratory paradigm and ecological momentary assessment (EMA) methods to evaluate the effects of atomoxetine on intermediate phenotypes associated with alcohol use and outcomes in clinical trials.