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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA021201-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TDCS + Active Retraining | Experimental | 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining |
|
| Sham TDCS + Active Retraining | Experimental | .1 mA of TDCS applied during active alcohol avoidance retraining |
|
| Active TDCS + Sham retraining | Experimental | 2.0 mA of TDCS applied during sham alcohol avoidance retraining |
|
| Sham TDCS + Sham Retraining | Sham Comparator | 0.1 mA of TDCS applied during sham alcohol avoidance retraining |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Retraining | Behavioral |
| ||
| Sham TDCS |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric D Claus, Ph.D. | Mind Research Network and LBERI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction | Albuquerque | New Mexico | 87106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TDCS + Active Retraining | 2.0 milliamps (mA) of transcranial direct current stimulation (TDCS) applied during active alcohol avoidance retraining Active Retraining Active TDCS |
| FG001 | Sham TDCS + Active Retraining | .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS |
| FG002 | Active TDCS + Sham Retraining | 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining |
| FG003 | Sham TDCS + Sham Retraining | 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TDCS + Active Retraining | 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS |
| BG001 | Sham TDCS + Active Retraining |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | At-risk alcohol drinkers ages 21-30 | Posted | Mean | Standard Deviation | drinks per drinking day | Screening Visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TDCS + Active Retraining | 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness at stimulation site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Claus | The Mind Research Network | 505-272-5028 | eclaus@mrn.org |
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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| Device |
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| Active TDCS | Device |
|
| Sham Retraining | Behavioral |
|
| 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 |
.1 mA of TDCS applied during active alcohol avoidance retraining
Active Retraining
Sham TDCS
| BG002 | Active TDCS + Sham Retraining | 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining |
| BG003 | Sham TDCS + Sham Retraining | 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Active TDCS + Sham Retraining | 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining |
| OG003 | Sham TDCS + Sham Retraining | 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | standard drinks per drinking day | 1 week post-baseline |
|
|
|
| Primary | 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. | Two participants in the Active TDCS/Sham retraining and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data. | Posted | Mean | Standard Deviation | standard drinks | 2 weeks post-baseline |
|
|
|
| Primary | 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. | Two participant in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data. | Posted | Mean | Standard Deviation | standard drinks | 3 weeks post-baseline |
|
|
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| Primary | 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. | One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data. | Posted | Mean | Standard Deviation | standard drinks | 4 weeks post-baseline |
|
|
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| Primary | 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. | One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data. | Posted | Mean | Standard Deviation | standard drinks | 5 weeks post-baseline |
|
|
|
| Primary | 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. | Two participants in the Active TDCS/Active Retraining, four participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and three participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data. | Posted | Mean | Standard Deviation | standard drinks | 8 weeks post-baseline |
|
|
|
| Primary | 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. | Three participants in the Sham TDCS/Active Retraining, one participant in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data. | Posted | Mean | Standard Deviation | milliseconds | 1 week after treatment |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | drinks per drinking day | Baseline |
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Sham TDCS + Active Retraining | .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS | 0 | 15 | 0 | 15 | 1 | 15 |
| EG002 | Active TDCS + Sham Retraining | 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining | 0 | 20 | 0 | 20 | 1 | 20 |
| EG003 | Sham TDCS + Sham Retraining | 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining | 0 | 20 | 0 | 20 | 0 | 20 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |