NCT03028662

Brief Summary

This is an experimental study in which the efficacy of three psychophysiological intervention modalities based on retrieval-extinction procedures is analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

October 11, 2016

Last Update Submit

March 7, 2023

Conditions

Alcoholism

Keywords

Alcohol DependenceBrain ConnectivityInhibition

Outcome Measures

Primary Outcomes (2)

  • Difference between pattern of brain connectivity after training-extinction and basal level

    2 days

  • Number of relapses during 3 months after training-extinction

    3 months

Secondary Outcomes (3)

  • Difference between plasma levels of BDNF after training-extinction and basal level

    2 days

  • Difference between attentional bias toward alcohol after training-extinction and basal level

    2 days

  • Difference between behavioral inhibition after training-extinction and basal level

    2 days

Study Arms (3)

Immediate exposure

EXPERIMENTAL

Exposure to video on alcohol (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.

Behavioral: Retrieval-Extinction Learning

Delayed exposure

ACTIVE COMPARATOR

Exposure to a video of alcohol consumption (update phase) followed (6 hours) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.

Behavioral: Retrieval-Extinction Learning

No exposure

ACTIVE COMPARATOR

Exposure to a video of neutral situations (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.

Behavioral: Retrieval-Extinction Learning

Interventions

Retrieval-Extinction LearningBEHAVIORAL

The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.

Delayed exposureImmediate exposureNo exposure

Eligibility Criteria

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

You may qualify if:

  • Alcohol-dependent patients who have been detoxified and abstinent take 10-14 days.

You may not qualify if:

  • Patients who do not sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (1)

  • Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.

    PMID: 21389338BACKGROUND

MeSH Terms

Conditions

AlcoholismInhibition, Psychological

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Gabriel Rubio Valladolid, Psychiatrist

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Psychiatrist, MD, PhD

Study Record Dates

First Submitted

October 11, 2016

First Posted

January 23, 2017

Study Start

January 1, 2016

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)