RISK: Risk Factors for Stress-induced Alcohol Misuse: Genetic Predictors and Mediation by Personality Type

Sponsor
Portsmouth Hospitals NHS Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT04533802
Collaborator
University of Portsmouth (Other)
150
1
12.2
12.3

Study Details

Study Description

Brief Summary

To examine whether variation in 'risk-taking' personality and linked genetic variants predicts susceptibility to, and resilience against, stress-induced alcohol misuse.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Alcohol misuse is a global health issue responsible for over 1 million hospital admissions per annum in the UK with a combined cost of approximately £21 billion. Chronic alcohol misuse in patients who attend hospital for alcohol-related illness/injury is common, with relapse and recidivism almost ubiquitous. Patients often report that 'stress' was a catalyst for their drinking episodes, but we do not know exactly who is most at risk, how stress leads to drinking, or the genetic basis for this risk. This research aims to seek to identify patients at higher risk of stress-induced alcohol misuse, or who are more resilient to stress in this context, using a combination of analyses ranging from genetic variants to personality tests and clinical follow-up. The ultimate goal is that patients engaging with alcohol services can receive personalised and focussed treatment and enhance recovery

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Personality and Genotypic Markers That Predict Individual Differences in Susceptibility to Stress-induced Alcohol Misuse: a Feasibility Study.
    Actual Study Start Date :
    Aug 26, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Alcohol misuse [immediately after the procedure]

      Measured using the alcohol use disorders identification test (AUDIT)

    2. Recent stressors [Immediately after the study visit]

      Measured using the 30 item Stress Overload Scale questionnaire

    3. Life Events [Immediately after the study visit]

      Measured using the Life Events Checklist Questionnaire

    4. Impulse Behaviour [Immediately after the study visit]

      Measured using the the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale (UPPS-P)

    5. Risk taking behaviour [Immediately after the study visit]

      Measured by the Stop Signal Reaction Time Task (computer task) which measures the ability to inhibit a planned response

    6. Molecular Anaylsis [Immediately after the study visit]

      Cheek swabs will be taken from all participant to carry out genomic DNA analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Male or Female, aged (min) 18 years

    • Attended Portsmouth Hospitals University Trust following illness/injury related to alcohol use

    • Has a maximum AUDIT score of 15

    • Is willing and able to comply with study procedures

    • Willing and able to give informed consent for participation in the study.

    • Must be recruited within 24 hrs of ASNS referral, and able to be tested within 48 hours of referral

    Exclusion Criteria:

    ny reported/suspected intellectual/learning disabilities (e.g., Down's Syndrome), neurodevelopmental disorders (e.g., Autism, Asperger's) or acquired brain injury

    • Has previously participated in this study

    • Should not be under the influence of alcohol during the study (12hrs previous to taking part) - to be determined via breathalyser.

    • Any history of advanced liver disease (clinical diagnosis of cirrhosis, jaundice, encephalopathy, ascites, variceal haemorrhage)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Portsmouth University Hospital Portsmouth Hampshire United Kingdom PO63LY

    Sponsors and Collaborators

    • Portsmouth Hospitals NHS Trust
    • University of Portsmouth

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Portsmouth Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04533802
    Other Study ID Numbers:
    • PHT/2019/63
    First Posted:
    Sep 1, 2020
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2020