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Completed

NCT Number: NCT02406456

Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders

Participants will undergo a single session of functional magnetic resonance imaging (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their ability to regulate motivational networks of the brain during the exposure to alcohol cues and evaluate immediate effects on craving and cognitive bias for alcohol by administering a questionnaire and a Stroop task before and after the session.

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Key information

Conditions

Alcohol Abuse Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol per week (female participants)

Exclusion criteria

  • MRI safety exclusion criteria

Treatment and study plan

Neurofeedback

Other

Primary outcomes

  1. Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)

    Time frame: 1 day

    This measure will be based on the analysis of participants' fMRI (functional magnetic resonance imaging) data, reflecting brain activation, during exposure to alcohol cues. Neurofeedback success will be defined as significant difference between activation levels (expressed as beta weights of a linear regression model) during the regulation periods compared to baseline. The significance will be determined by a t-test.

Secondary outcomes

  1. Drinking Urges Questionnaire as a measure of alcohol craving

    Time frame: 1 day

    Measure of alcohol craving

  2. Alcohol Stroop task as a measure of cognitive bias

    Time frame: 1 day

    Measure of cognitive bias

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Collaborators

  • European Commission

Registry information

Official study title

Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence - Protocol Optimisation Phase

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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