Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking

Alcoholism Clinical Trial

— MBItDCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861807
• Other study ID #: 04316
• Secondary ID: R21AA024926
• Status: Completed
• Phase: N/A
• Start date: November 22, 2016
• Est. completion date: August 27, 2018

Study information

• Verified date: November 2019
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Intoxication
• Alcoholic Intoxication
• Alcoholism

Intervention

Device:
• Brain stimulation with mindfulness-based relapse prevention
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.

Locations

Country	Name	City	State
United States	University of New Mexico Psychology Clinical Neuroscience Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Preve — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cue Reactivity at the Post-Treatment Assessment	To measure cue reactivity to alcohol, the investigators will use a visual cue presentation task. Participants will view pictures of alcohol containing beverages and neutral pictures from the International Affective Pictures Series (IAPS)118 and from the web. Alcohol and neutral pictures will be matched for color and complexity as well as other potentially important confounds (e.g., presence of people). The investigators will examine responses to approximately 100 trials each of alcohol pictures and control pictures in a mixed event design (~15 minutes), in order to reduce predictability of the picture type. After viewing pictures participants reported craving for alcohol on a scale from 1 to 9 (1=no craving, 9=extreme craving) with higher scores indicating worse outcomes.	Post-treatment
Other	Reductions in Self-reported Craving	Self-reported craving will be measured using the Penn Alcohol Craving Scale (scaled from 0 to 5 with higher scores indicate worse outcome = more craving) with higher scores mean a worse outcome.	2 months following treatment
Other	Improvements in Inhibitory Control	To examine inhibitory control, the investigators will use a Stop Signal Task in which participants make left-right judgments of the directionality of an arrow presented on the screen. For each trial, a circle will appear for 500 ms, followed by a left or right-pointing arrow for up to 1 second and between 500 ms and 2500 ms jittered inter-trial interval to reduce anticipatory responses. Approximately 25% of trials will be "stop trials" with a tone played to signal participants to inhibit the current response. This timing of the tone is dynamically adjusted to ensure successful inhibition on approximately 50% of trials. There will be 240 trials across 6 blocks (~10 minutes). Inhibitory control is measured by stop signal reaction time.	Post-treatment
Primary	Drinks Per Drinking Day	The Form 90 will be used to derive estimates of the primary outcome: drinks (standard drink=14 grams of pure alcohol) per drinking day.	Post-treatment and 2-month follow-up
Secondary	Percent Heavy Drinking Days	The Form 90 will be used to derive estimates of the secondary outcome: percent heavy drinking days, where heavy drinking is defined as 4+ drinks per occasion for women and 5+ drinks per occasion for men.	Post-treatment and 2-month follow-up

External Links

•   Mindfulness recordings used for home practice during trial