NCT02045108

Brief Summary

The overarching goal of this study is to determine whether combined cognitive training and Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To this end, specific study purposes are: 1) replicate previous findings that cognitive retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with tDCS, and 3) investigate the neural changes that result from cognitive retraining and tDCS. We hypothesize that those participants who receive alcohol avoidance cognitive training will have greater reductions in drinking. In turn, those participants who receive a higher level of applied tDCS during alcohol avoidance response training will have better avoidance learning, as well as, a larger reduction in drinking behavior. Finally, those participants receiving a higher level of applied tDCS will have more neuronal response associated with alcohol avoidance during the brain imaging session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration 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, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 20, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

January 20, 2014

Results QC Date

January 29, 2018

Last Update Submit

March 16, 2018

Conditions

Binge Drinking

Outcome Measures

Primary Outcomes (10)

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day of the prior 30 days. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    Screening Visit

  • Alcohol Approach Bias

    For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.

    Baseline

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    1 week post-baseline

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    2 weeks post-baseline

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    3 weeks post-baseline

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    4 weeks post-baseline

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    5 weeks post-baseline

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    8 weeks post-baseline

  • Alcohol Approach Bias

    For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.

    1 week after treatment

  • Drinks Per Drinking Day

    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

    Baseline

Study Arms (4)

Active TDCS + Active Retraining

EXPERIMENTAL

2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining

Behavioral: Active RetrainingDevice: Active TDCS

Sham TDCS + Active Retraining

EXPERIMENTAL

.1 mA of TDCS applied during active alcohol avoidance retraining

Behavioral: Active RetrainingDevice: Sham TDCS

Active TDCS + Sham retraining

EXPERIMENTAL

2.0 mA of TDCS applied during sham alcohol avoidance retraining

Device: Active TDCSBehavioral: Sham Retraining

Sham TDCS + Sham Retraining

SHAM COMPARATOR

0.1 mA of TDCS applied during sham alcohol avoidance retraining

Device: Sham TDCSBehavioral: Sham Retraining

Interventions

Active RetrainingBEHAVIORAL
Active TDCS + Active RetrainingSham TDCS + Active Retraining
Sham TDCSDEVICE
Sham TDCS + Active RetrainingSham TDCS + Sham Retraining
Active TDCSDEVICE
Active TDCS + Active RetrainingActive TDCS + Sham retraining
Sham RetrainingBEHAVIORAL
Active TDCS + Sham retrainingSham TDCS + Sham Retraining

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-30 years
  • At least five binge drinking episodes (4+ drinks for men; 3+ drinks for women) for the past month
  • Alcohol Use Disorder Identification Test (AUDIT) score greater than 8
  • Right handed

You may not qualify if:

  • History of treatment for alcohol dependence (AD) or desire for treatment
  • History of alcohol withdrawal
  • History of brain injury
  • Currently taking psychotropic medications (e.g. antidepressants, antipsychotics)
  • Female subjects who are pregnant
  • Evidence of recent illicit drug use on a urine screen
  • Left handed
  • Prior participation in a brain stimulation study
  • Implanted brain medical devices
  • Electromedical devices
  • Latex allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Binge Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Results Point of Contact

Title
Dr. Eric Claus
Organization
The Mind Research Network
eclaus@mrn.org
505-272-5028

Study Officials

  • Eric D Claus, Ph.D.

    Mind Research Network and LBERI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 20, 2018

Results First Posted

March 20, 2018

Record last verified: 2018-03

Locations

US(1)