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Alcohol Drinking clinical trials

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NCT ID: NCT05895643 Recruiting - Clinical trials for Alcohol Use Disorder

Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

SEMALCO
Start date: June 13, 2023
Phase: Phase 2
Study type: Interventional

This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI>30 kg/m2). Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26. The primary endpoint is the percentage-point reduction in total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.

NCT ID: NCT05893277 Recruiting - Clinical trials for Alcohol Use Disorder

Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India

Harmony
Start date: October 12, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to test an intervention consisting of a combination of behavioral couples therapy and motivational interviewing to improve communication and reduce conflicts between couples and decrease harmful drinking among spouses in urban primary health centers, South India. The intervention will be delivered by nurses in primary health centers who will be supervised by a clinical psychologist. The main question[s] it aims to answer are: - Do the wives of the couples in the intervention report less intimate partner violence (IPV) after 12 months, compared to wives in couples in a control group? - Do the husbands of the couples in the intervention show less alcohol consumption after 12 months, compared to husbands in couples in a control group? Husbands will participate in Motivational Interview (MI) sessions targeted at reducing their alcohol use. Husband and wife will participate in Behavioral Couples Therapy (BCT) targeted at improving their marital relationship. These intervention participants will be compared to a control group who will receive only referral information for intimate partner violence and an educational session and referral for alcohol use disorder. All participants will participate in quantitative interviews at baseline, and every three months thereafter, for a period of one year. In-depth qualitative interviews will be done with a subgroup of couples to try to understand how the intervention led to the observed outcomes.

NCT ID: NCT05892432 Recruiting - Clinical trials for Alcohol Use Disorder

Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

Start date: January 11, 2024
Phase: Phase 2
Study type: Interventional

This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD. The investigators will randomly assign 50 participants to receive semaglutide (titrated to 7 milligrams (mg) per day) or matched placebo for 8 weeks. The primary aims are to assess the safety and tolerability of semaglutide in this population and to evaluate its effects, relative to placebo, on alcohol cue-elicited craving and alcohol consumption.

NCT ID: NCT05885594 Recruiting - Clinical trials for Alcohol Use Disorder

Imaging Inflammation With Alcohol Use Disorder: an [18F]NOS Study

AUD
Start date: April 25, 2023
Phase: Early Phase 1
Study type: Interventional

Study to enroll up to 90 individuals, those with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30). PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer [18F]NOS. All participants will have one [18F]NOS positron emission tomography/ computed tomography (PET/CT) scan performed.

NCT ID: NCT05884619 Recruiting - Clinical trials for Alcohol Use Disorder

Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder

Start date: August 14, 2023
Phase: N/A
Study type: Interventional

This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of dual-target deep brain stimulation for treatment-resistant alcohol use disorder.

NCT ID: NCT05873556 Completed - Alcohol Consumption Clinical Trials

Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

Project ACE
Start date: May 8, 2023
Phase: N/A
Study type: Interventional

This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention mainly focuses on providing feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.

NCT ID: NCT05873413 Recruiting - Alcohol Drinking Clinical Trials

Motivations, Attitudes, and Perceptions Study

MAP
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the impact of providing participants with 1. A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone 2. Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol) 3. A control condition focused on reducing stress The main questions it aims to answer are: - Is Motivate-the-Bystander more effective than the attention control for increasing bystander behaviors? - Is Motivate-the-Bystander+Alcohol more effective than MTB alone for increasing bystander behaviors? - Is Motivate-the-Bystander+Alcohol more effective than Motivate-the-Bystander alone for decreasing alcohol use during bystander intervention opportunities? Participants will: - Complete online measures (e.g., self-reported bystander behaviors, past bystander training, history of bystander intervention attempts, sexual experiences, drinking behaviors, and other substance use behaviors) - Complete either MTB, MTB+ALC, or the attention control condition online - Complete the virtual reality simulation in the lab - Complete electronic daily diary follow-up surveys about alcohol use and bystander intervention

NCT ID: NCT05870111 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Citicoline in Youth Alcohol Use Disorder

Start date: July 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.

NCT ID: NCT05864235 Enrolling by invitation - Alcohol Consumption Clinical Trials

Texting to Reduce Alcohol Misuse Pilot Trial

TRAM
Start date: May 4, 2023
Phase: N/A
Study type: Interventional

The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.

NCT ID: NCT05863182 Not yet recruiting - Clinical trials for Alcohol Use, Underage

JUNTOS Familia Preventive Intervention

Juntos
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to develop and pilot-test a family-based Latino youth alcohol use preventive intervention for Latino youth (ages 14-16) and one of their parents. The preventive intervention will equip youth, parents, and families with skills to manage stress related to prejudice, discrimination, and racism as a means to reduce Latino youth alcohol use risk. Informed by ecodevelopmental, social norms, family stress, stress and coping theories, and racial socialization theories, the central hypothesis is that active coping skills can buffer against the negative effect of social stressors (i.e., experiences related to prejudice, discrimination, and racism) on youth alcohol outcomes/related risks/cognitions; and active coping skills can offset the negative effect of social stress on parental adjustment, family functioning and parenting behaviors, thereby reducing youth alcohol use risk. Using an iterative approach to intervention development, within a mixed-method research design, the purpose of this study is to construct intervention sessions that impart active coping skills to better manage social stress related to prejudice, discrimination, and racism. In Aim 1, we will use qualitative methods to inform the development of intervention sessions that target coping with prejudice, discrimination, and racism. I will conduct focus groups with youth (5 groups, n=6-8) and parents (5 groups, n=6-8) to identify how youth and parents experience and cope with perceived ethnic discrimination; the skills and resources they would like to further develop; and to seek input regarding the structure and logistics of the intervention. In Aim 2, we will create a family-based youth alcohol use preventive intervention curriculum that targets coping with prejudice, discrimination, and racism. I will identify strategies used in existing preventive interventions and draw from Aim 1 qualitative findings to develop tentative intervention sessions. We will then conduct focus groups with youth (5 groups, n=6-8) and parents (5 groups, n=6-8) to seek feedback on tentative intervention sessions. We will then integrate focus group data into the intervention curriculum and modify it accordingly and develop manuals in English and Spanish. In Aim 3, we will pilot test the intervention among Latino families (i.e., one youth and one parent) in Texas. We will pilot test the intervention with 60 families (i.e., youth-parent dyads; N=30 intervention group; N = 30 comparison group) from high schools in the Austin Independent School District to a) assess intervention feasibility and acceptability, and b) determine preliminary effect size estimates for the intervention's promise to improve youth and parent coping skills, family functioning, parenting behaviors, and youth alcohol outcomes.