Gut Hormones in Obesity, Nicotine and Alcohol Dependence

What Was Tested

In this early phase 1 trial, researchers set out to test Exenatide and Ghrelin.

The "Gut Hormones in Addiction" study is a proof-of-concept experimental medicine human study to answer the following questions: 1.

It had three arms (groups): Overweight/obese subjects (experimental), Ex-smokers (experimental) and Ex-alcohol dependent subjects (experimental).

Overweight/obese volunteers with BMI 28.0-50.0 kg/m2, otherwise healthy. This group will receive interventions with saline as placebo, Exenatide and desacyl ghrelin infusions at separate visits in a within subject randomised crossover design.

Abstinent tobacco dependent individuals who score at least moderately on tobacco dependence as measured retrospectively using the Fagerström Test for Nicotine Dependence (FTND), and who have been in stable tobacco abstinence for at least 6 weeks. This group will receive interventions with saline as placebo, Exenatide and desacyl ghrelin infusions at separate visits in a within subject randomised crossover design.

Abstinent alcohol dependent individuals who score at least moderately alcohol dependent as measured retrospectively using the Severity of Alcohol Dependence Questionnaire (SADQ), and who have been abstinent for at least 6 weeks. This group will receive interventions with saline as placebo, Exenatide and desacyl ghrelin infusions at separate visits in a within subject randomised crossover design.

The registry classes the interventions as biological and drug.

More on the Plan

Obesity, smoking and alcohol dependence are major health burdens to society.

Relapse after alcohol and smoking abstinence is common despite the use of combined behavioural support and current limited available medications.

In obesity, nonsurgical interventions have also been disappointing in achieving longterm weight loss.

Therefore, there is a pressing need to develop novel drug treatments for addiction derived from knowledge of brain mechanisms related to relapse and reward responses to food and drugs.

Who Took Part

The registry lists 95 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female volunteers between the ages of 18 and 60 years. The subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. The subject is able to read, comprehend and record information written in English. For non-dependent groups:. For addiction groups:.

The full record lists 6 inclusion and 30 exclusion criteria; among the exclusions: for individual groups:; carbon monoxide levels of =/\>10ppm in the overweight/obese and abstinent smoker groups at screening visit; claustrophobia or feels that they will be unable to lay still on their back in the mri scanner for a period of \~80 minutes.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-08 with completion listed for 2019-08-21.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Functional MRI measure of brain activation during cigarette, alcohol and food picture evaluation task (time frame: 4 years).

It also tracked 5 secondary outcomes, for example Functional MRI measure of brain activation during anticipation of winning monetary reward (monetary incentive delay task), Functional MRI measure of brain activation during negative emotional reactivity task, Functional MRI measure of brain activity in salience resting state network, Functional MRI measure of brain activity in limbic resting state network and Functional MRI measure of brain activity in default mode resting state network.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Exenatide and Ghrelin in 95 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Ghrelin compound page, all human trials.