scholarly journals Opioid and Dopamine Genes Interact to Predict Naltrexone Response in a Randomized Alcohol Use Disorder Clinical Trial

2020 ◽  
Vol 44 (10) ◽  
pp. 2084-2096 ◽  
Author(s):  
Raymond F. Anton ◽  
Konstantin E. Voronin ◽  
Sarah W. Book ◽  
Patricia K. Latham ◽  
Patrick K. Randall ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Dopamine Genes

Pilot randomized placebo‐controlled clinical trial of high‐dose gabapentin for alcohol use disorder

2021 ◽  
Author(s):  
John J. Mariani ◽  
Martina Pavlicova ◽  
Cale Basaraba ◽  
Agnieszka Mamczur‐Fuller ◽  
Daniel J. Brooks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Controlled Clinical Trial ◽  
High Dose

scholarly journals Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking

2019 ◽  
Vol 43 (5) ◽  
pp. 937-944 ◽  
Author(s):  
Krysten W. Bold ◽  
Allen Zweben ◽  
Lisa M. Fucito ◽  
Mary E. Piepmeier ◽  
Srinivas Muvvala ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Cigarette Smoking ◽  
Randomized Clinical Trial ◽  
Alcohol Use Disorder

scholarly journals Randomized clinical trial of exercise for nontreatment seeking adults with alcohol use disorder.

2020 ◽  
Vol 34 (1) ◽  
pp. 65-75
Author(s):  
Jeremiah Weinstock ◽  
Nancy M. Petry ◽  
Linda S. Pescatello ◽  
Craig E. Henderson ◽  
Casey R. Nelson
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Randomized Clinical Trial ◽  
Alcohol Use Disorder

A Randomized Clinical Trial of Fecal Microbiota Transplant for Alcohol Use Disorder

Hepatology ◽  
2020 ◽  
Author(s):  
Jasmohan S Bajaj ◽  
Edith A Gavis ◽  
Andrew Fagan ◽  
James B Wade ◽  
Leroy R Thacker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Randomized Clinical Trial ◽  
Alcohol Use Disorder ◽  
Fecal Microbiota ◽  
Fecal Microbiota Transplant

scholarly journals Exploring the Role of Alcohol Metabolizing Genotypes in a 12-Week Clinical Trial of Naltrexone for Alcohol Use Disorder

Biomolecules ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1495
Author(s):  
João M. Castaldelli-Maia ◽  
André Malbergier ◽  
Adriana B. P. de Oliveira ◽  
Ricardo A. Amaral ◽  
André B. Negrão ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Alcohol Use Disorders ◽  
Nucleotide Polymorphisms ◽  
High Association ◽  
Unsuccessful Treatment ◽  
Naltrexone Treatment ◽  
The Individual

Background: The efficacy of naltrexone in the treatment of alcohol use disorder (AUD) has been associated with a set of variables not directly related with the expression of opioid receptors. All the variables have been found to be highly associated with AUD itself or more severe clinical levels of AUD. Objectives: Given the high association between alcohol metabolizing enzymes (AME) and the outcome of AUD, the present study aims to investigate the role of AME genotype variants in the treatment of AUD with naltrexone. Methods: We carried out a 12-week longitudinal clinical trial based on the treatment of AUD patients with naltrexone (N = 101), stratified by different alcohol metabolization genotypes. Genotyping was performed after the inclusion of the patients in the study, based on the individual presence of single nucleotide polymorphisms (SNPs) in the ADH (alcohol dehydrogenase)1B (ADH1B*2 and ADH1B*3), ADH1C (ADHC*1) and ALDH (aldehyde dehydrogenase) 2 (ALDH2*2) genes. The outcome of alcohol use has been monitored employing the timeline follow-back during the treatment. Results: The ADH1C*1 (Ile350Val, rs698) and ALDH2*2 (Glu504Lys, rs671) polymorphisms were associated with a better response to naltrexone treatment, whereas the ADH1B*3 (Arg370Cys, rs2066702) allelic variant showed a negative outcome. Conclusions: The present study explores a genomic setting for the treatment of AUD with naltrexone. According to our findings, the association between ADH1C*1 and ALDH2*2 variants and better outcomes suggests a successful treatment, whereas the ADH1B*3 mutated allele might lead to an unsuccessful treatment. Further studies should be performed to investigate the relationship between alcohol metabolizing genotypes, the family history of alcohol use disorders and the effect of naltrexone on the outcomes. Genotyping may be a valuable tool for precision-medicine and individualized approach, especially in the context of alcohol use disorders. The small number of subjects was the main limitation of the present study.

scholarly journals Ibudilast for Alcohol Use Disorder: Study protocol for a phase II randomized clinical trial

2020 ◽  
Author(s):  
Elizabeth M. Burnette ◽  
Wave-Ananda Baskerville ◽  
Erica N. Grodin ◽  
Lara A. Ray
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Randomized Clinical Trial ◽  
Alcohol Use Disorder ◽  
Safety Data ◽  
Heavy Drinking ◽  
Phosphodiesterase Inhibitor ◽  
Neural Activation ◽  
Double Blind ◽  
Clinical Safety

Abstract Background Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets. Ibudilast, a phosphodiesterase inhibitor, has been advanced as a novel addiction pharmacotherapy that targets neurotrophin signaling and neuroimmune function. Methods This study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, percent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in to a neuroimaging session in which we examine the effects of ibudilast on neural activation to psychosocial stress and alcohol cues. Finally, we will also collect plasma levels of proinflammatory markers, as well as subjective and biological (salivary cortisol) markers of stress response.Discussion This study will further develop ibudilast, a safe and promising novel compound with strong preclinical and clinical safety data for AUD, and will probe biological mechanisms underlying the effects of Ibudilast on stress, neuroinflammation, and alcohol cue-reactivity and craving. If ibudilast proves superior to placebo in this study, it will set the stage for a confirmatory multi-site trial leading to FDA approval of a novel AUD treatment. Trial Registration ClinicalTrials.gov, NCT03594435 “Ibudilast for the Treatment of Alcohol Use Disorder”, registered July 20, 2018.

scholarly journals Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Elizabeth M. Burnette ◽  
Wave-Ananda Baskerville ◽  
Erica N. Grodin ◽  
Lara A. Ray
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Randomized Clinical Trial ◽  
Alcohol Use Disorder ◽  
Safety Data ◽  
Heavy Drinking ◽  
Phosphodiesterase Inhibitor ◽  
Neural Activation ◽  
Double Blind ◽  
Clinical Safety

Abstract Background Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets. Ibudilast, a phosphodiesterase inhibitor, has been advanced as a novel addiction pharmacotherapy that targets neurotrophin signaling and neuroimmune function. Methods This study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50 mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, percent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in to a neuroimaging session in which we examine the effects of ibudilast on neural activation to psychosocial stress and alcohol cues. Finally, we will also collect plasma levels of proinflammatory markers, as well as subjective and biological (salivary cortisol) markers of stress response. Discussion This study will further develop ibudilast, a safe and promising novel compound with strong preclinical and clinical safety data for AUD, and will probe biological mechanisms underlying the effects of Ibudilast on stress, neuroinflammation, and alcohol cue-reactivity and craving. If ibudilast proves superior to placebo in this study, it will set the stage for a confirmatory multi-site trial leading to FDA approval of a novel AUD treatment. Trial registration ClinicalTrials.gov NCT03594435 “Ibudilast for the Treatment of Alcohol Use Disorder”. Registered on 20 July 2018.

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