Alcohol DrinkingMBItDCSNCT02861807
Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
A study testing Brain stimulation with mindfulness-based relapse prevention in people with Alcohol Drinking and Alcohol Intoxication, run by University of New Mexico at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Alcohol Intoxication, Alcoholism
- What is being tested?
- Brain stimulation with mindfulness-based relapse prevention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to 27 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- interested in reducing alcohol drinking
- right-handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Psychology Clinical Neuroscience Center
Albuquerque, New Mexico, 87131
About this study
Official title: Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change
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.
Read the 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.
- Conditions
- Alcohol Drinking, Alcohol Intoxication, Alcoholism
- Being tested
- Brain stimulation with mindfulness-based relapse prevention
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain stimulation with mindfulness-based relapse preventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Brain stimulation with mindfulness-based relapse prevention |
| 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. Receives: Device: Brain stimulation with mindfulness-based relapse prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment and 2-month follow-up
Secondary outcomes (1)
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.
Measured: Post-treatment and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start22 Nov 2016
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861807
- Sponsor's protocol ID
- 04316
- Other IDs
- R21AA024926
- Acronym
- MBItDCS
- Status last verified
- Nov 2019
- First submitted
- 3 Aug 2016
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30977904Brown 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.
PubMed 31825472Gibson 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.
PubMed 35833199
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change
- ClinicalTrials.gov ID
- NCT02861807
- Acronym / sponsor ID
- MBItDCS / 04316
- Conditions
- Alcohol Drinking, Alcohol Intoxication, Alcoholism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation with mindfulness | Experimental | Device: Brain stimulation with mindfulness-based relapse preventionBrain 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 comparator | Device: Brain stimulation with mindfulness-based relapse preventionBrain 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- interested in reducing alcohol drinking
- right-handed
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain stimulation with mindfulness-based relapse preventionParticipants 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. | Device | Active stimulation with mindfulness, Sham brain stimulation with mindfulness |
Primary outcome
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.
1 secondary outcome
Percent Heavy Drinking Days
Time frame: Post-treatment and 2-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30977904Witkiewitz 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.
- Results publication: PubMed 31825472Brown 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.
- Derived from this study: PubMed 35833199Gibson 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.
- Mindfulness recordings used for home practice during trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain stimulation with mindfulness-based relapse prevention in people with Alcohol Drinking and Alcohol Intoxication, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks Per Drinking Day (time frame: Post-treatment and 2-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.