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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA024926 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation with mindfulness | Experimental | 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. |
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| Sham brain stimulation with mindfulness | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain stimulation with mindfulness-based relapse prevention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Psychology Clinical Neuroscience Center | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30977904 | Result | 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. | |
| 31825472 | Result | 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. |
| Label | URL |
|---|---|
| Mindfulness recordings used for home practice during trial | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | drinks per drinking day | Post-treatment and 2-month follow-up |
|
1 year, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Witkiewitz | University of New Mexico | 505-277-4121 | katiew@unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2018 | Dec 20, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000435 | Alcoholic Intoxication |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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Double blind
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| Post-treatment |
| 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 |
| 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 |
| 35833199 | Derived | 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Drinks per Drinking Occasion | This measure, evaluating participants' number of drinks (standard drinks,14 grams of pure alcohol) per drinking occasion, was collected during the phone screen questionnaire, which occurred prior to the baseline assessment. Randomization to treatment condition was stratified based on this measure. | Mean | Standard Deviation | drinks per drinking occasion |
|
| OG001 | 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. 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of heavy drinking days | Post-treatment and 2-month follow-up |
|
|
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Score on a scale | Post-treatment |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Score on a scale | 2 months following treatment |
|
|
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | milliseconds | Post-treatment |
|
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|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 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. 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. | 0 | 37 | 0 | 37 | 0 | 37 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |