Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial

Published: 16 September 2022| Version 1 | DOI: 10.17632/hck4tvrhbb.1
Contributors:
Mette Klausen,
Anders Fink-Jensen

Description

Data from a 26 week long, randomised, double-blinded, placebo-controlled clinical trial, investigating the effects of the once-weekly GLP-1 receptor agonist exenatide on reduction in alcohol intake in 127 patients diagnosed with Alcohol Use Disorder (AUD) in the suburbs of Copenhagen, Denmark. Data was collected from august 2017 to October 2020. Alcohol intake was recorded with the Time-Line-Follow-Back method. A sub-group of the patients had a SPECT and an fMRI brain scan performed at baseline and at followup. Published in: Klausen MK et al. Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial. JCI Insight. 2022; doi:10.1172/jci.insight.159863 Available data collected at week 0, week 4, week 12, week 20, and week 26 are: - Heavy drinking days in the last 30 days (week 0, 4, 12, 20, 26) - Days without alcohol in the last 30 days (week 0, 4, 12, 20, 26) - Total alcohol-intake in the last 30 days (week 0, 4, 12, 20, 26) - Socio-economical status (week 0) - AUDIT score (week 0, week 26) - DUDIT-score (week 0 and week 26) - Diagnostic critereria for AUD according to DSM-5 and ICD-10 (week 0) - SCIP test (cognition) (week 0, week 4, week 26) - Routine blood tests* (week 0, week 26) - Safety blood tests** (week 4, week 12, week 20) - SF-36 questionaire (danish) (week 0, week 26) - SCL-92 questionaire (danish) (week 0, week 26) - PACS questionaire (danish) (week 0, week 12, week 26) - Fagerstrøms questionaire (week 0, week 4, week 12, week 20, week 26) - Blood pressure, puls (week 0, week 4, week 12, week 20, week 26) - Height, weight, BMI, waist (abdominal) circumference (week 0, week 4, week 12, week 20, week 26) - Other medication (week 0) - Oxidative stress parameters; urine 8-oxoGuo & urine-8oxodG (week 0, week 26) - Bonemarkers; Plasma-TRAcP-5b, Plasma-CTX, Plasma-P1NP (week 0, week 26) - FGF-21 (week 0, week 26) - Plasma exenatide and anti-exenatide antibody binding (week 0, week 26) Brain-Imaging: Access criteria to this data-set is a methodologically sound proposal with an approved aim directed to corresponding authors (anders.fink-jensen@regionh.dk or mette.kruse.klausen@regionh.dk), and requestors will potentially have to sign a data access agreement. - fMRI resting state, N-back task, ALCUE task (week 0, week 26) - SPECT DAT availability (week 0, week 26) Biobank for future research: (available pr. demand) - Full blood, serum, plasma, urine (stored in a minus 80 degree freezer) (week 0, week 26) * MCV, basophilocytes, eosinophils, lymphocytes, monocytes, neutrophils, hemoglobin, B-lymphocytes, thrombocytes, HbA1c, blood sugar level, vitamin B12, albumin, potassium, creatinine, eGFR, sodium, ALAT, amylase, alkaline phosphatase, GGT, HDL, LDL, VLDL, plasma cholesterol, triglycerides, TSH, Vitamin D, INR. ** amylase (week 4, week 12, week 20); ALAT, GGT, creatinine, eGFR (week 12)

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Steps to reproduce

- PLEASE see the "drop-outs.xlsx" file for the actual time of the final assesment named "followup" or "week 26" -Treatment group: 1=placebo, 2=exenatide -NA = missing data -Follow-up = week 26 -Gender: 1= female, 2=male -Zero-days = days without alcohol measured within the last 30 days with the validated Time-line Follow-back method -Heavy drinking days is measured within the last 30 days with the validated Time-line Follow-back method -Total alcohol intake is measured within the last 30 days with the validated Time-line Follow-back method -SCIP: risolid = benzodiazepine (0=no drug, 1=benzodiazepine intake), Week 0= SCIP test 3, week 4=SCIP test 1, week 26 = SCIP test 2 -Weight = Kilogram -Amylase: method 1= referencelevel 10-65, method 2= referencelevel 25-120 -Urine oxidative stress: 8-oxoGuo & 8-oxodG =nmol/mmol creatinine -Bonemarkers: Plasma-TRAcP-5bb (U/L), Plasma-CTXb (ng/L), Plasma-P1NPb (μg/L) -FGF-21 = pg/mL -Plasma exenatide =pmol/L, Overall anti-exenatide antibody binding =% -Socioeconomic status: married (yes=1, no=2), job (yes=1, no=2), Education level (0=lower secondary school, 1=upper secondary school, 2&3 =Vocational education/short-cycle higher education, 4&5 =Medium cycle higher education/Higher education -DSM5 critera: Yes = 0, No = 1 -ICD-10: Yes = 0, No = 1

Categories

Neuroscience, Addiction, Biomarkers, Single-Photon Emission Computed Tomography, Clinical Trial, Placebo, Glucagon-Like Peptide-1, Fibroblast Growth Factor, Oxidative Stress, Functional Magnetic Resonance Imaging, Alcoholism, Brain Imaging, Alcohol, Liver Marker, Randomized Controlled Trial, Alcohol Craving, Addiction Medicine, Addictive Disorder, Receptor Agonist, Intervention, Alcohol Addiction Treatment, Alcohol Dependence, Blood Banking, Glucagon-Like Peptide-1 Receptor Agonist

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