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Alcohol Use Disorder clinical trials

View clinical trials related to Alcohol Use Disorder.

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NCT ID: NCT05093296 Completed - Clinical trials for Alcohol Use Disorder

Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

ON-ICE
Start date: December 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Alcohol use disorder (AUD) is a chronic relapsing disorder. Alcohol craving, a hallmark symptom of AUD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound is Oxytocin (OXY), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, OXY seems to enhance effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist which is approved for AUD treatment via positive synergism on neurotransmitter levels. The proposed two-armed, 1:1 randomized, double-blind, parallel group trial seeks to test the putative synergistic effects of combined intranasal OXY spray (24 IU) + oral NTX (50mg) against Placebo spray + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AUD that suffer from high alcohol craving, within the framework of a validated alcohol cue-and stress-exposure task (i.e. a combined Trier Stress Test and alcohol cue-exposure) that was established for screening new medications in AUD and determine their effects on craving and relapse risk. Treatment effects on additional neurobiological and biochemical markers of craving that show strong associations to individual relapse risk, will serve as secondary outcomes. Collection and analysis of follow-up data (90 days) will be performed to determine whether treatment effects relate to patient outcome. The clinical trial period for an individual participant consists of a screening visit (visit 1), a baseline visit (visit 2) and two treatment visits (visits 3 and 4)(all within equal or less than ten days) followed by a 90 days (+/- 7 days) follow-up phase with two visits (visits 5 and 6) at day 30 (± 7 days) and day 90 (± 7 days). Visits 1 to 4 will be conducted while participants are undergoing standard in-patient treatment at the Department of Addictive Behavior and Addiction medicine at the Central Institute of Mental Health (CIMH) in Mannheim, Germany, for the medical condition under investigation.

NCT ID: NCT05048758 Completed - Clinical trials for Alcohol Use Disorder

Adverse Childhood Experiences in Alcohol Use Disorder

Start date: November 22, 2021
Phase:
Study type: Observational

Adverse childhood experiences (ACE) and their relation to the development of an alcohol use disorder (AUD) will be measured with functional magnetic resonance imaging (fMRI).

NCT ID: NCT04973202 Completed - Clinical trials for Alcohol Use Disorder

Portrayal of Hospital Alcohol Detoxification in France

Alcostop
Start date: May 1, 2021
Phase:
Study type: Observational

Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate factors associated with longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators aim to compare the stays by facility type.

NCT ID: NCT04964687 Completed - Clinical trials for Alcohol Use Disorder

Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.

Start date: October 1, 2019
Phase:
Study type: Observational

Investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. Our hypothesis is that patients managed by an addiction team before and after liver transplantation have less frequent alcohol relapses, thus decreasing the risk of cardiovascular complications, de novo cancer, recurrence of alcohol-related cirrhosis, and consequently increasing their overall survival.

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: 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: 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.

NCT ID: NCT04727086 Completed - Clinical trials for Alcohol Use Disorder

Role of BP1.3656 on Alcohol Responses

Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).