Effects of Ghrelin on Alcohol Cue Reactivity and Craving
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Only a few medications are approved for the treatment of alcohol dependence and there exists
      a substantial need for discovering ways to provide more effective treatments. Accordingly,
      identifying new potential neuropharmacological targets in the treatment of alcohol dependence
      represents a high priority in public health. Ghrelin is a 28-amino acid peptide acting as the
      endogenous ligand for the growth hormone secretagogue receptor (GHS-R). Ghrelin was first
      isolated from the stomach, but a central hypothalamic production of ghrelin has also been
      demonstrated. Ghrelin plays a key role in the regulation of appetite. Consistent with the
      common neurobiological substrates for control of food and alcohol consumption, preclinical
      investigations suggest that ghrelin plays a role in the neurobiology of alcohol dependence,
      thus representing a new potential neuropharmacology target. In keeping with the preclinical
      studies, human investigations showed that alcohol consumption affects blood ghrelin levels
      and that blood ghrelin levels significantly and positively correlate with craving
      measurements in alcohol-dependent individuals. The effects of exogenous ghrelin injected
      intravenous (i.v.) in alcohol-dependent individuals, however, have never been investigated.
      The current project proposes a randomized double-blind placebo-controlled 3-group
      between-subject laboratory study aimed at investigating the effects of exogenous ghrelin i.v.
      on non-treatment seeking alcohol-dependent subjects in terms of urges to drink, attention to
      cues and related psychophysiological measures. This project has the goals to: i) conduct an
      alcohol laboratory study testing the role of ghrelin i.v., therefore demonstrating the
      feasibility of such a study and the safety of ghrelin i.v. when administered to
      alcohol-dependent individuals; and ii) explore the effects of ghrelin i.v. on alcohol craving
      assessed under controlled conditions, such as a cue-reactivity (CR) experiment.

      This study will address whether alcohol craving is affected when ghrelin levels are modified
      acutely via a ghrelin i.v. injection. Given the crucial need to expand our understanding of
      the underlying neurobiology of alcoholism, this study potentially will lead to identify new
      targets for the development of pharmacological treatments that may improve interventions for
      alcohol dependent individuals.
    


Intervention name(s): Ghrelin; Ghrelin; Saline solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.; A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.; Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Other intervention name(s): human acetylated ghrelin; human acetylated ghrelin; matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: alcoholism; ghrelin; craving