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Alcoholism clinical trials

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NCT ID: NCT04925076 Completed - Clinical trials for Effects of Family History of Alcoholism and Sex on Alcohol Analgesia

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Start date: November 20, 2018
Phase: N/A
Study type: Interventional

Self-medication of pain with alcohol is a common, yet risky, behavior. Evidence suggests family history of alcoholism may affect the degree to which alcohol use relieves pain, but the independent contributions of expectation and conditioning have not been previously studied. Interactive effects of sex and family history are also currently unclear. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

NCT ID: NCT04906616 Completed - HIV/AIDS Clinical Trials

An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

Start date: May 31, 2021
Phase: N/A
Study type: Interventional

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.

NCT ID: NCT04893044 Completed - Clinical trials for Alcohol Use Disorder

Alcohol Misuse Intervention in Active Duty US Navy Personnel

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

A pilot trial among ship-board US Navy personnel surrounding a holiday weekend tested an evidence-based video on responsible drinking. Service members >18 years were eligible to volunteer if they were aboard during data collection. Participants were randomized to intervention or control arms, with all given a brief survey before (T1) and after (T2) the weekend. The intervention arm viewed a 3-minute video at T1. A urine specimen collected at T1 and T2 for ethyl glucuronide (EtG) measurement used >100ng/ml for significant alcohol use. Multivariable regression measured odds of detecting EtG at T2, controlling for T1 EtG detectability, age, and alcohol misuse at baseline per AUDIT-C. 86 subjects participated at T1, and 100 at T2, with complete data for 72 (control, n=34; intervention, n=38) who participated in both T1 and T2 were analyzed. Average age was 28 years with 25% and 32% reporting white or black/African-American, 54% married and 84% <E6. At T1, 22% (n=16) and T2, 32% (n=23) had EtG>100ng/ml. At T1, 50% and 55% in control and intervention arms respectively, screened positive for alcohol misuse by AUDIT-C; T1 AUDIT-C screen positivity was significantly associated with detecting EtG>100ng/ml at T1 (p=0.04). Control arm EtG>100ng/ml participants increased 1.7-fold over the weekend, from n=7 at T1 to n=12 at T2; the intervention arm had no increase in EtG>100ng/ml participants, with n=11 at T1 and n=11 at T2.

NCT ID: NCT04873453 Completed - Clinical trials for Alcohol Use Disorder

CBD for the Treatment of Alcohol Use Disorder

Start date: August 30, 2021
Phase: Phase 2
Study type: Interventional

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (CBD) and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

NCT ID: NCT04861792 Completed - Clinical trials for Alcohol Use Disorder (AUD)

Michigan SPARC Trial

MI-SPARC
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided. The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers. The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs. Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.

NCT ID: NCT04858061 Completed - Clinical trials for Alcohol Use Disorder

"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. The current study aims to test the efficacy of a Virtual Reality Cue-Exposure Therapy (VR-CET) patients diagnosed with severe AUD, who made several failed attempts to cease alcohol drinking. It is expected that VR-CET is more efficient in reducing AUD symptomatology and preventing relapses than treatment-as-usual (TAU). 80 participants will be randomly assigned to experimental or control group. The experimental group will receive treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) over the course of five weeks. VR-CET booster sessions consist of exposure to preferred alcoholic beverages and alcohol-related contexts in a VR environment. Throughout the six VR-CET sessions, momentary anxiety and alcohol craving levels will be assessed. The control group will receive only treatment-as-usual (TAU).

NCT ID: NCT04832321 Completed - Clinical trials for Alcohol Use Disorder (AUD)

Measuring Beliefs and Norms About Persons With Alcohol Use Disorder

Start date: February 19, 2021
Phase: N/A
Study type: Interventional

Survey experiment to estimate drivers of stigma toward people with alcohol use disorder

NCT ID: NCT04827056 Completed - Clinical trials for Alcohol Use Disorder (AUD)

Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study

Start date: November 9, 2021
Phase: Phase 1
Study type: Interventional

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. Safety endpoints will be compared following an alcohol challenge without and concurrent with BXCL501 treatment.

NCT ID: NCT04817410 Completed - Clinical trials for Alcohol Use Disorder

ED Initiated Oral Naltrexone for AUD

Start date: September 28, 2021
Phase: Phase 1
Study type: Interventional

This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.

NCT ID: NCT04811729 Completed - Clinical trials for Alcohol Use Disorder

Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption

ALCO-AP20
Start date: February 18, 2022
Phase: N/A
Study type: Interventional

- Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC). - Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.