Clinical trial NCT02861807: Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
Official title: Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Intoxication
Alcoholism
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-08-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Heavy drinking (defined as 4+/5+ drinks per occasion for women/men) and alcohol use disorder (AUD) are a significant public health problem. Modestly effective pharmacological and psychosocial treatments for AUD exist, yet some heavy drinking (i.e., relapse) is the most common outcome following AUD treatment. Continued development of innovative and efficacious interventions that reduce heavy drinking and specifically target risk factors for heavy drinking is thus clearly warranted. One novel intervention that has considerable promise for reducing heavy drinking is mindfulness-based relapse prevention (MBRP). MBRP is a behavioral intervention for substance use disorder that was designed to target experiences of craving and other risk factors for heavy drinking. Based on the results of numerous studies, MBRP is feasible and efficacious in the treatment of AUD. However the effect sizes of MBRP remain small and many individuals struggle with engaging in the mindfulness practices early in treatment. There is preliminary evidence that combining a non-invasive form of brain stimulation, transcranial direct current stimulation (tDCS), may improve engagement with mindfulness practices and lead to significant reductions in heavy drinking following treatment. The goal of the proposed study is to examine the efficacy of a mindfulness + tDCS intervention in reducing heavy drinking and impacting hypothesized mechanisms of behavior change among individuals with AUD who are interested in reducing their heavy drinking. In the proposed study, a research team with complementary expertise in AUD treatment, mindfulness-based interventions, brain stimulation, and cognitive neuroscience will combine self-report, behavioral, and neurophysiological data collection via electroencephalography (EEG) to study the psychological and neurophysiological mechanisms of treatment efficacy following a novel, promising intervention that combines brain stimulation with mindfulness training. The mindfulness based intervention in combination with active tDCS is hypothesized to lead to significant reductions in drinks per drinking day after 8 weeks of treatment and these reductions will be maintained up to 2 months following treatment. Further, the effect of active tDCS on drinks per drinking day at the 2 month follow-up will be mediated by greater mindfulness, greater inhibitory control and reductions in craving and negative affect during treatment and at the post-treatment assessment. Approximately 86 individuals meeting criteria for AUD will be randomly assigned to 8 sessions of either MBRP combined with active tDCS (up to 2.0 milliamp current) or MBRP combined with a sham tDCS (no current) control condition. The proposed study will examine the efficacy (Primary Aim) and psychological and neurophysiological mechanisms of treatment efficacy using behavioral measures and EEG (Secondary Aim). In addition to addressing the question of whether adding active tDCS to MBRP enhances efficacy, it will further examine issues of neurophysiological and behavioral treatment mechanisms to better inform the design of a future large efficacy trial.

Eligibility criteria: Inclusion Criteria:

1. interested in reducing alcohol drinking
2. right-handed

Exclusion Criteria:

1. lifetime diagnosis of schizophrenia or bipolar disorder or current substance use disorder other than nicotine or marijuana
2. cardiac pacemaker
3. implantable defibrillator
4. 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
5. for females, pregnant or attempting to get pregnant
6. history of seizures or seizure disorder
7. allergic to latex, rubber, conductive medium like saline or electrode gel
8. if assigned to active tDCS and unable to tolerate 1.5 mA of tDCS during a baseline stimulation session

Primary outcomes:
measure: Drinks Per Drinking Day
timeFrame: Post-treatment and 2-month follow-up
Secondary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: Post-treatment and 2-month follow-up
Other outcomes:
measure: Cue Reactivity at the Post-Treatment Assessment
timeFrame: Post-treatment
measure: Reductions in Self-reported Craving
timeFrame: 2 months following treatment
measure: Improvements in Inhibitory Control
timeFrame: Post-treatment
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Psychology Clinical Neuroscience Center
state: New Mexico
Study officials:
References:
citation: Witkiewitz K, Stein ER, Votaw VR, Wilson AD, Roos CR, Gallegos SJ, Clark VP, Claus ED. Mindfulness-Based Relapse Prevention and Transcranial Direct Current Stimulation to Reduce Heavy Drinking: A Double-Blind Sham-Controlled Randomized Trial. Alcohol Clin Exp Res. 2019 Jun;43(6):1296-1307. doi: 10.1111/acer.14053. Epub 2019 May 9.
citation: Brown DR, Jackson TCJ, Claus ED, Votaw VR, Stein ER, Robinson CSH, Wilson AD, Brandt E, Fratzke V, Clark VP, Witkiewitz K. Decreases in the Late Positive Potential to Alcohol Images Among Alcohol Treatment Seekers Following Mindfulness-Based Relapse Prevention. Alcohol Alcohol. 2020 Feb 7;55(1):78-85. doi: 10.1093/alcalc/agz096.
citation: Gibson BC, Votaw VR, Stein ER, Clark VP, Claus E, Witkiewitz K. Transcranial Direct Current Stimulation Provides no Additional Benefit to Improvements in Self-Reported Craving Following Mindfulness-Based Relapse Prevention. Mindfulness (N Y). 2022 Jan;13(1):92-103. doi: 10.1007/s12671-021-01768-5. Epub 2021 Nov 26.