NCT02406456

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

March 26, 2015

Last Update Submit

November 10, 2015

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 day

Secondary Outcomes (2)

  • Drinking Urges Questionnaire as a measure of alcohol craving

    1 day

  • Alcohol Stroop task as a measure of cognitive bias

    1 day

Study Arms (1)

Neurofeedback

EXPERIMENTAL
Other: Neurofeedback

Interventions

NeurofeedbackOTHER
Neurofeedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • David Linden, MD

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Translational Neuroscience

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 2, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

GB(1)