New Therapeutic Strategies for Inhibitory Control in Alcoholism
1 other identifier
interventional
105
1 country
1
Brief Summary
This experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral prefrontal cortex.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
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
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 8, 2023
March 1, 2023
4.7 years
February 15, 2017
March 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Relapses
Number of relapses
3 months
Heavy drinking
Number of days of heavy drinking
3 months
Abstinence
Days of accumulated abstinence
3 months
Secondary Outcomes (3)
Behavioral Impulsivity
2 days
Self-reported Impulsivity
2 days
Polymorphism distribution of CRH and ANK3 genes
2 days
Study Arms (4)
Exposure
EXPERIMENTALExposure to a 5 minutes video related to alcohol consumption (updating/retrieval), followed by 10 minutes of the alcohol- AAT(Approach Avoidance Task) (extinction), during 4 days of training (2 weeks).
No exposure
ACTIVE COMPARATORExposure to a 5 minutes video with neutral content (no retrieval) followed by 10 minutes of the alcohol- AAT (Approach Avoidance Task) , during 4 days of training.
Active rTMS
EXPERIMENTALEach session (5 sessions along 2 weeks), patients receive active stimulation with repetitive transcraneal magnetic stimulation (rTMS) of the right dorsolateral prefrontal cortex.
SAM
SHAM COMPARATORPacients receiving a sham stimulation (SAM), with a similar procedure to the experimental condition
Interventions
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.
Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with Magstim Rapid coil. rTMS is performed at 10 Hz, during 4.9 seconds,for each set of stimuli (20), with a interval between sets of 30 seconds.
Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with SAM coil.
Eligibility Criteria
You may qualify if:
- Men and women aged between 18 and 50 years old.
- A minimum of 28 days of abstinence
- Consent to participate in the study.
You may not qualify if:
- Subjects with other substance dependence ( with the exception of tobacco)
- Subjects with a history of brain injury or neurological diseases
- Denial for study participation
- Non-spanish speakers
- rTMS selected participants with be assed in order to discard epilepsy, presence for metallic elements and CNS valves
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (2)
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: 21389338BACKGROUNDMishra BR, Nizamie SH, Das B, Praharaj SK. Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Addiction. 2010 Jan;105(1):49-55. doi: 10.1111/j.1360-0443.2009.02777.x.
PMID: 20078462BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Rubio Valladolid, Psychiatrist
Hospital Universitario 12 de Octubre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blinded experiment regarding rTMS treatment is applied to both subjects and investigators. The only non-masked role is for the technician applying either Magstim Rapid or SAM coils to each group of subjects.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psychiatrist, MD, PhD
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 20, 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