N/A
N=77
Cognitive Retraining and Brain Stimulation for Alcohol Use
Binge Drinking
Bottom Line
View on ClinicalTrials.gov: NCT02045108 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Drinks Per Drinking Day — 6.1; 6.8; 6.6; 7.5 drinks per drinking day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Retraining (Behavioral); Sham TDCS (Device); Active TDCS (Device); Sham Retraining (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- The Mind Research Network
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Alcohol Approach Bias |
41.6; 143.6; 51.9; 66.6 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
| PRIMARY Alcohol Approach Bias |
41.6; 143.6; 51.9; 66.6 | — |
| PRIMARY Drinks Per Drinking Day |
5.7; 5.5; 6.2; 6.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02045108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.