Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
MBItDCS
2 other identifiers
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedStudy Start
First participant enrolled
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2018
CompletedResults Posted
Study results publicly available
November 26, 2019
CompletedFebruary 5, 2020
November 1, 2019
1.8 years
August 3, 2016
December 20, 2018
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percent Heavy Drinking Days
Post-treatment and 2-month follow-up
Other Outcomes (3)
Cue Reactivity at the Post-Treatment Assessment
Post-treatment
Reductions in Self-reported Craving
2 months following treatment
Improvements in Inhibitory Control
Post-treatment
Study Arms (2)
Active stimulation with mindfulness
EXPERIMENTALBrain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to 2.0 milliamps (mA) and guided meditation practice.
Sham brain stimulation with mindfulness
SHAM COMPARATORBrain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to ramp up to 2.0 milliamps (mA) and then ramp down to 0.0 mA and guided meditation practice.
Interventions
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.
Eligibility Criteria
You may qualify if:
- interested in reducing alcohol drinking
- right-handed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Psychology Clinical Neuroscience Center
Albuquerque, New Mexico, 87131, United States
Related Publications (3)
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.
PMID: 30977904RESULTBrown 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.
PMID: 31825472RESULTGibson 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.
PMID: 35833199DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We were unable to assess alcohol biomarkers and relied entirely on self-reported drinking, which may be prone to errors. Another potential limitation is the relatively higher age and wide age range of this sample (52.3 years, SD 13.00, range 19-77).
Results Point of Contact
- Title
- Katie Witkiewitz
- Organization
- University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 10, 2016
Study Start
November 22, 2016
Primary Completion
August 27, 2018
Study Completion
August 27, 2018
Last Updated
February 5, 2020
Results First Posted
November 26, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
The investigators will make the data publicly available given that it will be a unique data set that will not only allow for further exploration by alcohol researchers, but also allow for methods development by the broader research community. The investigators plan to release the data to the public once the primary manuscripts describing the main findings of the study have been accepted for publication. Anonymized and preprocessed EEG data as well as deidentified behavioral and questionnaire data will be shared with investigators from institutions with a Federal Wide Assurance; all investigators with whom the data is shared will be included in the annual progress report. To ensure accessibility of the data set, instructions for obtaining the data set will be included in publications of the data collected under this grant.