N/A
N=84
Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
Alcohol Drinking · Alcohol Intoxication · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT02861807 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Drinks Per Drinking Day — 5.12; 5.64; 4.95; 5.48 drinks per drinking day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brain stimulation with mindfulness-based relapse prevention (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drinks Per Drinking Day |
5.12; 5.64; 4.95; 5.48 | — |
| SECONDARY Percent Heavy Drinking Days |
27.42; 25.93; 29.51; 28.80 | — |
Summary
Alcohol use disorder (AUD) impacts millions of Americans and is associated with significant behavioral, social, economic, medical, and neurobiological dysfunction, yet current behavioral treatments for AUD are only modestly effective. The proposed research will test the efficacy of a novel behavioral intervention, which combines brain stimulation with mindfulness-based relapse prevention, and is hypothesized to improve neural dysfunction and ultimately lead to large effect size reductions in heavy drinking among individuals with AUD. Given that mindfulness and brain stimulation are already available for "home use" there is great potential for the ultimate dissemination of the intervention on a large scale, which could have a significant impact on public health.
Eligibility Criteria
Inclusion Criteria
- interested in reducing alcohol drinking
- right-handed
Exclusion Criteria
- lifetime diagnosis of schizophrenia or bipolar disorder or current substance use disorder other than nicotine or marijuana
- cardiac pacemaker
- implantable defibrillator
- metal objects in upper body that might interfere with tDCS, or that tDCS may interfere with their function, including metal plates, screws and prosthetics in head, certain older tattoos and permanent makeup using metal containing inks, aneurysm clips, neural stimulators of any kind, ear implants, insulin pumps, drug infusion devices and dental appliances
- for females, pregnant or attempting to get pregnant
- history of seizures or seizure disorder
- allergic to latex, rubber, conductive medium like saline or electrode gel
- if assigned to active tDCS and unable to tolerate 1.5 mA of tDCS during a baseline stimulation session
Data sourced from ClinicalTrials.gov (NCT02861807). 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.