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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861807
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : November 26, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Intoxication Alcoholism Device: Brain stimulation with mindfulness-based relapse prevention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change
Actual Study Start Date : November 22, 2016
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Arm Intervention/treatment
Experimental: Active stimulation with mindfulness
Brain 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.
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.

Sham Comparator: Sham brain stimulation with mindfulness
Brain 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.
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.




Primary Outcome Measures :
  1. Drinks Per Drinking Day [ Time Frame: Post-treatment and 2-month follow-up ]
    The Form 90 will be used to derive estimates of the primary outcome: drinks (standard drink=14 grams of pure alcohol) per drinking day.


Secondary Outcome Measures :
  1. Percent Heavy Drinking Days [ Time Frame: Post-treatment and 2-month follow-up ]
    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.


Other Outcome Measures:
  1. Cue Reactivity at the Post-Treatment Assessment [ Time Frame: Post-treatment ]
    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.

  2. Reductions in Self-reported Craving [ Time Frame: 2 months following treatment ]
    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.

  3. Improvements in Inhibitory Control [ Time Frame: Post-treatment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861807


Locations
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United States, New Mexico
University of New Mexico Psychology Clinical Neuroscience Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  Study Documents (Full-Text)

Documents provided by University of New Mexico:
Additional Information:
Publications of Results:
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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT02861807    
Other Study ID Numbers: 04316
R21AA024926 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2016    Key Record Dates
Results First Posted: November 26, 2019
Last Update Posted: February 5, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Additional relevant MeSH terms:
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Alcoholism
Alcoholic Intoxication
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior