CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Brain stimulation with mindfulness-based relapse preventiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02861807
NCT02861807N/ACompleted

Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change

University of New Mexico·interventional·Posted Aug 10, 2016·Updated Feb 5, 2020

In Brief

A clinical study evaluating Brain stimulation with mindfulness-based relapse prevention for Alcohol Drinking and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartNov 22, 2016
Primary CompletionAug 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.9 years ago

Interventions

Brain stimulation with mindfulness-based relapse preventiondevice

Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice.