NCT04533802

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 3, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

August 26, 2020

Last Update Submit

March 30, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Alcohol misuse

    Measured using the alcohol use disorders identification test (AUDIT) (higher the score the worse the outcome)

    immediately after the procedure

  • Recent stressors

    Measured using the 30 item Stress Overload Scale questionnaire (higher the score, the worse the outcome)

    Immediately after the study visit

  • Life Events

    Measured using the Life Events Checklist Questionnaire (the higher the score the worse the outcome)

    Immediately after the study visit

  • Impulse Behaviour

    Measured using the the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale (UPPS-P) higher values indicate more impulsive behavior.

    Immediately after the study visit

  • Risk taking behaviour

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

    Immediately after the study visit

  • Molecular Anaylsis

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

    Immediately after the study visit

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be patients attending Portsmouth Hospitals University Trust following alcohol-related illness/injury and an AUDIT score of greater than 15 (suggesting high risk of dependence and alcohol misuse). They will be adults (\>18 years).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth University Hospital

Portsmouth, Hampshire, PO63LY, United Kingdom

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 1, 2020

Study Start

August 26, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations