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Alcoholism clinical trials

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NCT ID: NCT06395467 Not yet recruiting - Clinical trials for Alcohol Use Disorder

12-Step Facilitation/MET/CBT (InTEGRA) vs. MET/CBT for Youth With Alcohol and Other Drug Use Disorder: A Multisite RCT

InTEGRA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This is a Phase II parallel group randomized controlled trial with 294 adolescents (age: 14-21 years) with substance use disorder, that compares two different active psychosocial interventions designed to address adolescent substance use disorder. Participants are recruited from our clinical settings and the community at two sites: one in the metro Boston, MA area and the other in the metro Farmington CT, area. Study aims and hypotheses are as follows: 1. To extend the evidence for the initial efficacy of InTEGRA relative to gold standard MET/CBT alone in a larger cohort (N=294). It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence rates, and fewer substance-related negative consequences. 2. Investigate the personal recovery capital (PRC) and social recovery capital (SRC) mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time (e.g., PRC: motivation, self-efficacy, coping; SRC: 12-step involvement; social network changes). 3. Investigate moderators of InTEGRA's effects on outcomes across one-year follow-up (e.g., effect of age, network support for AOD use; psychiatric severity; age composition of 12-step meetings on substance use and substance-related consequences). It is hypothesized that higher network support for AOD use, abstinence motivation, and greater AOD severity, will have a better response to InTEGRA. 4. Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design.

NCT ID: NCT06381609 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Peer Support in Alcohol Dependence

PEERSIAD
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment. However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome. Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation. Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care. This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome.

NCT ID: NCT06380985 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury

TABM
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.

NCT ID: NCT06371404 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat

Start date: June 1, 2024
Phase:
Study type: Observational

The overall objective of this study it to use Positron Emission Tomography (PET) brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 (HDAC6) to examine HDAC6 expression in people with Post-Traumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), or concurrent PTSD and AUD with control groups. While there are a large number of studies conducted in preclinical stress and addiction models, these findings have not been translated to people living with these disorders. We will examine relationships between HDAC6 and clinical variables of interest. Findings could direct treatment development.

NCT ID: NCT06367348 Not yet recruiting - HIV/AIDS Clinical Trials

An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi

Start date: January 2025
Phase: N/A
Study type: Interventional

With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.

NCT ID: NCT06349083 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

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

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

NCT ID: NCT06337721 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults

Start date: September 2024
Phase: N/A
Study type: Interventional

This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT).

NCT ID: NCT06335407 Not yet recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

Start date: April 29, 2024
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) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.

NCT ID: NCT06333457 Not yet recruiting - Alcohol Dependence Clinical Trials

Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality

PRE-VR
Start date: April 1, 2024
Phase:
Study type: Observational

Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates. Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months. Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.

NCT ID: NCT06333288 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.