Gut Hormones in Obesity, Nicotine and Alcohol Dependence

What this study is testing ClinicalTrials.gov NCT02690987 ↗

Description as written by the study sponsor.

The "Gut Hormones in Addiction" study is a proof-of-concept experimental medicine human study to answer the following questions: 1. Does the administration of the hormone desacyl ghrelin reduce core behavioural components of addiction in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects? 2. Does the administration of the drug Exenatide reduce core behavioural components of addiction in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects? 3. Does the administration of desacyl ghrelin or Exenatide reduce reward responses to high-calorie foods and appetite in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects?

Treatments tested

• Exenatide also known as Byetta Drug

  Exenatide is a commercially available GLP-1 receptor agonist. It is a synthetic form of exendin-4, a protein extracted from the saliva of a Gila monster lizard, which exhibits 53% sequence identity to human GLP-1. The planned intravenous Exenatide infusion dose is expected to be 0.06 pmol/kg/min aiming for maintenance plasma concentrations of \~130-190 pg/mL.

• Desacyl ghrelin also known as Unacylated ghrelin Biologic

  Ghrelin is a 28 amino acid stomach-derived peptide hormone, with the desacyl ghrelin (DAG) form inactive at the GHSR1a receptor. Good Manufacturing Practice (GMP)-grade DAG is obtained from Clinalfa (Bachem AG, Bubendorf, Switzerland). The planned intravenous DAG infusion dose is expected to be 4.0 mcg/kg/hour aiming for maintenance plasma concentrations of \~13-19 ng/mL.

• Saline Biologic

  The placebo visit will involve an intravenous infusion of normal saline.