Gene variants influence on GSK1521498 effects on food & alcohol cues

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, crossover study to evaluate the influence of the A118G polymorphism in the Mu opioid receptor gene (OPRM1) on effects of GSK1521498 and naltrexone on physiological and behavioural markers of brain function in healthy overweight social drinkers.

• IRAS ID

  115653

• Contact name

  Disala Fernando

• Sponsor organisation

  GlaxoSmithKline R&D

• Eudract number

  2012-002479-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is the sixth clinical research study with the new drug GSK1521498, which blocks the effects of messenger molecules in the brain called opioids. Opioids are naturally produced within the human body, and are involved in how we respond to reward, including eating too much of high fat and high sugar foods, the misuse of alcohol and abuse of other dependence-inducing drugs, and how we respond to pain. GSK1521498 may therefore have use for some forms of addiction. This clinical research study is designed to compare the effects of GSK1521498, of another drug (naltrexone) which is licensed as a treatment for some forms of addiction, and against a dummy drug (placebo). There is evidence that variation in a specific gene can fluence the response to this type of drug, and this will be investigated in this study. 48 healthy people who are overweight, social drinkers, are a member of a genotyping panel (i.e. had their genes pre-tested), and pass eligibility criteria will take part in 3 separate 5-day treatment periods in a random order. During the 5 days subjects, will stay in the unit for at least 2 overnight stays. There will be a washout period of at least 2 weeks between treatment periods. 7 to 10 days after the last dose of study medication there will be a final follow up visit. The comparison between treatments will be based on tests of brain activity (including questionnaires, computer tests and brain scan), eating and drinking alcohol habits or preferences, and a test of pain. The study is sponsored by GlaxoSmithKline and will be conducted in a specialist clinical research unit in the UK, with adequate safety and compliance facilities.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1688

• Date of REC Opinion

  19 Nov 2012

• REC opinion

  Favourable Opinion