Alcohol DrinkingNCT04430543
Neural and Behavioral Effects of Cognitive Bias Modification (CBM)
A study testing Cognitive Bias Modification in people with Alcohol Drinking, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study seeks to better understand mechanisms of behavior change for heavy drinkers who are interested in changing their drinking. The study will examine the effects of CBM as an adjunctive treatment on neurocognitive processes related to alcohol use in a sample of heavy/at-risk drinkers using functional magnetic… Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 31 Aug 2021
- 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 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- current hazardous drinking (score of 8+ on USAUDIT-C)
- interest in changing drinking
- English-speaking
- able to provide informed consent
Who cannot join
- Score of 25+ on USAUDIT
- current or past treatment for alcohol or drug use
- lifetime diagnosis of other substance use disorder
- self-reported weekly or more other drug use as indicated on the NIDA-modified Alcohol, Smoking, and Substance Involvement Screening Test
- history of head injury or loss of consciousness
- lifetime diagnosis of bipolar disorder, psychotic symptomatology, organic mental disorder, seizure disorder, or central nervous system disease
Show all 10Show fewer
- pregnancy
- current use of psychotropic medication
- history of delirium tremens and/or seizures as a result of alcohol withdrawal
- contraindications to fMRI (claustrophobia, pregnancy, metal, pacemaker, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rajen Kilachand Center for Integrated Life Sciences and Engineering at Boston University
Boston, Massachusetts, 02215
About this study
Official title: Addressing Problem Drinking From the Bottom-Up: An Investigation of the Neural and Behavioral Effects of Cognitive Bias Modification (CBM)
This study seeks to better understand mechanisms of behavior change for heavy drinkers who are interested in changing their drinking. The study will examine the effects of CBM as an adjunctive treatment on neurocognitive processes related to alcohol use in a sample of heavy/at-risk drinkers using functional magnetic resonance imaging (fMRI). The primary aim of this project is to examine the effects of CBM on neurocognitive approach tendencies and control processes, among heavy/at-risk drinkers interested in changing their alcohol use. As a secondary aim, this project will investigate associations between neural and cognitive changes and changes in alcohol use to better understand how CBM might lead to successful changes in drinking behavior. Either CBM (treatment group) or sham computer task (control group) will be paired with a motivational web-based intervention for alcohol use. Brain activity will be measures twice via fMRI--pre-treatment and 1-week post-treatment. The experimental tasks completed in the fMRI scans include 2 alcohol cue reactivity (CR) tasks--one standard and one in which participants are told to either inhibit (INHIBIT) or engage in (INDULGE) their reaction to images of alcohol and neutral beverages. Follow-up drinking behavior will be measured also at 1-week and online via 1- and 6-month follow-ups. Brain activity at baseline and follow-up will be measured in pre-defined regions of interest including amygdala, NAcc, mPFC, and dlPFC. It is hypothesized that the CBM group will exhibit changes in approach biases as exhibited by reductions in brain activity in the amygdala, NAcc, mPFC in response to alcohol cues in both CR tasks (alcohol CR, INDULGE CR, and INHIBIT CR) compared to sham. In addition, those in the CBM group will show increased dlPFC brain activity during alcohol CR and INHIBIT trials of the cued-CR task as evidence strengthened control abilities in response to alcohol cues. Finally, as a secondary hypothesis, those in the CBM group will show greater reductions in drinking and craving at follow-up.
Read the detailed description
Forty heavy/at-risk drinkers (ages 18-34) who report an interest in changing their drinking behavior will be recruited for this proposed project. "Interest" will be operationalized as an affirmative answer on an item adapted (for past-month) from the CAGE questionnaire: "In the past month, have you felt you should cut down or stop drinking?" (Mayfield, McLeod, \& Hall, 1974). Heavy/at-risk drinking will be defined in terms of consumption (7+/14+ drinks per week and/or 3+/4+ drinks on one occasion over the past week for women and men, respectively; USDHHS, 2005) and score on the Alcohol Use Disorders Identification Test (AUDIT score of 8-19; Babor, Higgins-Biddle, Saunders, \& Monteiro, 2001). A score between 8-19 on the AUDIT is indicative of heavy use while scores 20 and above are indicative of a more severe alcohol use disorder (i.e., "dependence", DSM-IV; APA, 2013; APA, 2000). Participants will be recruited through online advertisements on Craigslist, social media websites, and "Quickie Job Board" listings on student websites as well as via flyers in community and student health centers. Upon responding to advertisements participants will be administered a phone screen or complete online screening survey to determine study eligibility.
If eligible, baseline assessments will be administered at an in person appointment, including self-report assessments about alcohol use, drug use, consequences, and alcohol craving. Participants will complete a baseline fMRI scan, which involves administration of two versions of an alcohol cue reactivity (CR) task. Both CR tasks administered in the scanner will consist of a block design. The first alcohol CR task consists of two types of blocks-1) alcohol and 2) neutral beverage (i.e., soft drinks, juice, water). Subjects will be presented with 40 alcohol images and 40 neutral beverage images, respectively. The second task, the cued-CR task, involves 3 blocks utilizing the same images as the alcohol-CR task. Subjects will receive instructions regarding their reaction to the photos-1) INHIBIT CR (alcohol images), 2) INHIBIT NEUTRAL (neutral beverage images), and 3) INDULGE CR (alcohol images). More specifically, participants will be given the instruction to imagine each image is available to them and to either inhibit their natural reaction to the images presented (alcohol in one block, neutral beverages in another block) or think about the possibility of consuming, in this moment, each (alcohol-containing) beverage shown. This task was inspired by fMRI studies using CR tasks and cognitive restraint strategies to inhibit cravings for food and/or alcohol (Naqvi et al., 2015; Yokum \& Stice, 2013). For both tasks, each image will be presented for 4 seconds followed by a 2 second inter-image interval. Participants will be asked to rate their level of craving after each block for the first task only. Following this baseline scan, participants will complete a brief web-based intervention for alcohol use, Rethinking Drinking: Alcohol and Your Health (NIAAA, 2015), and will subsequently be randomized to either cognitive bias modification (CBM) or sham training. They will complete the first session of either CBM or sham training after randomization as well as an additional 4 CBM/sham sessions at home (via web) over one week following baseline. Participants will return to the lab one-week following their baseline appointment. At follow-up assessment, participants will complete all baseline assessment measures in addition to a second fMRI session consisting of the same CR tasks. Finally, participants will be emailed a link to a web-based survey at 1- and 6-months following baseline to assess drinking behavior. Data analysis will employ region of interest (ROI) analysis. Predefined ROIs include the bilateral amygdala, nucleus accumbens (NAcc), and dorsolateral and medial prefrontal cortex (dlPFC and mPFC). Anatomical ROIs will be generated using the Wake Forest University (WFU) Pickatlas automatic anatomical labeling tool (Maldjian, Laurienti, Kraft, \& Burdette, 2003) available for SPM. The analytic plan for testing study hypotheses are as follows: Primary Aim 1-For the alcohol CR task, two within subject contrasts will be calculated-1] alcohol CR > neutral CR pre-CBM/sham and 2] (alcohol CR > neutral CR) pre-CBM/sham - (alcohol CR > neutral CR) post-CBM/sham-in pre-defined ROIs. Primary Aim 2-as with the alcohol CR task, the within subject contrasts will be 1] INDULGE CR > INHIBIT CR pre-CBM/sham and 2] (INDULGE CR > INHIBIT CR) pre-CBM/sham - (INDULGE CR > INHIBIT CR) post-CBM/sham. Similar within subject contrasts will be explored for INHIBIT CR and INHIBIT NEUTRAL CR as a control. T-tests will be used to compare within subject contrasts for each task as well as to compare between-group contrasts (i.e., alcohol CR and INHIBIT CR pre-and post- CBM/sham). Secondary Aim: Correlations will be run to determine whether BL BOLD activity in each ROI significantly correlate with behavioral measures for both BL and 1-week follow-up. For significant correlations, pre- and post-CBM/sham difference scores will be calculated for behavioral measures and then correlated with significant BOLD contrasts representing change in neural activity.
- Conditions
- Alcohol Drinking
- Being tested
- Cognitive Bias Modification, Sham Training
- Keywords
- motivation, alcohol-related disorders, self-control
- Medical subject headings
- Alcohol Drinking, Alcohol-Related Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias ModificationBehavioural
CBM sessions are computer tasks that take 15 minutes each. CBM is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when "pulled" and will get smaller as if moving away when "pushed". CBM will involve pushing 90% of alcohol stimuli (pulling 10%) and pulling 90% of neutral stimuli (pushing 10%).
Sham TrainingBehavioural
Sham training sessions are computer tasks that take 15 minutes each. Sham training is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when "pulled" and will get smaller as if moving away when "pushed". Sham training will involve pushing and pulling 50% of each type of stimuli (alcohol and neutral)
| Study group | Role | What they receive |
|---|---|---|
| CBM Group | Experimental | This group will receive Cognitive Bias Modification training Receives: Behavioral: Cognitive Bias Modification |
| Control Group | Sham comparator | This group will receive Sham (control) training Receives: Behavioral: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) Signal Change
Blood oxygen level dependent (BOLD) signal change in ROIs [amygdala, nucleus accumbent (NAcc), medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (dlPFC) during alcohol cue-reactivity decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
Measured: 1-week
BOLD Signal Change in ROIs (Amygdala, NAcc, mPFC, dlPFC) During INHIBIT Cue-reactivity
Decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
Measured: 1-week
BOLD Signal Change in ROIs (Amygdala, NAcc, mPFC) During INDULGE Cue-reactivity
Decreased BOLD signal change in ROIs indicates better outcomes for amygdala, NAcc, and mPFC
Measured: 1-week
Secondary outcomes (5)
Drinking Behavior
Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome
Measured: 1-week
Drinking Behavior
Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome
Measured: 1-month
Drinking Behavior
Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome
Measured: 6-months
Alcohol Craving
Score on Desire for Alcohol Questionnaire; range (average of all 14 items) = -3 - 3; higher scores reflect higher desire for alcohol (worse outcome)
Measured: 1-week
Alcohol Craving
Score on Desire for Alcohol Questionnaire; range (average of all 14 items) = -3 - 3; ; higher scores reflect higher desire for alcohol (worse outcome)
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start21 Aug 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: Study terminated early due to COVID -19 and subsequent inability to run subjects at the facility.
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.
- 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
- Model description
- There will be 2 groups- treatment group and control group. Both groups will receive a web-based motivational intervention then will be randomized to Cognitive Bias Modification or Sham (control) training. Participants will complete a total of 5 sessions of CBM or Sham over the course of a week.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Kelli Tahaney, M.A., Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430543
- Sponsor's protocol ID
- 4633E
- Other IDs
- 1F31AA025522-01A1
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2020
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Problem Drinking From the Bottom-Up: An Investigation of the Neural and Behavioral Effects of Cognitive Bias Modification (CBM)
- ClinicalTrials.gov ID
- NCT04430543
- Acronym / sponsor ID
- 4633E
- Conditions
- Alcohol Drinking
- Keywords
- motivation, alcohol-related disorders, self-control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to COVID -19 and subsequent inability to run subjects at the facility.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 2 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to better understand mechanisms of behavior change for heavy drinkers who are interested in changing their drinking. The study will examine the effects of CBM as an adjunctive treatment on neurocognitive processes related to alcohol use in a sample of heavy/at-risk drinkers using functional magnetic resonance imaging (fMRI). The primary aim of this project is to examine the effects of CBM on neurocognitive approach tendencies and control processes, among heavy/at-risk drinkers interested in changing their alcohol use. As a secondary aim, this project will investigate associations between neural and cognitive changes and changes in alcohol use to better understand how CBM might lead to successful changes in drinking behavior. Either CBM (treatment group) or sham computer task (control group) will be paired with a motivational web-based intervention for alcohol use. Brain activity will be measures twice via fMRI--pre-treatment and 1-week post-treatment. The experimental tasks completed in the fMRI scans include 2 alcohol cue reactivity (CR) tasks--one standard and one in which participants are told to either inhibit (INHIBIT) or engage in (INDULGE) their reaction to images of alcohol and neutral beverages. Follow-up drinking behavior will be measured also at 1-week and online via 1- and 6-month follow-ups. Brain activity at baseline and follow-up will be measured in pre-defined regions of interest including amygdala, NAcc, mPFC, and dlPFC. It is hypothesized that the CBM group will exhibit changes in approach biases as exhibited by reductions in brain activity in the amygdala, NAcc, mPFC in response to alcohol cues in both CR tasks (alcohol CR, INDULGE CR, and INHIBIT CR) compared to sham. In addition, those in the CBM group will show increased dlPFC brain activity during alcohol CR and INHIBIT trials of the cued-CR task as evidence strengthened control abilities in response to alcohol cues. Finally, as a secondary hypothesis, those in the CBM group will show greater reductions in drinking and craving at follow-up.
Detailed description
Forty heavy/at-risk drinkers (ages 18-34) who report an interest in changing their drinking behavior will be recruited for this proposed project. "Interest" will be operationalized as an affirmative answer on an item adapted (for past-month) from the CAGE questionnaire: "In the past month, have you felt you should cut down or stop drinking?" (Mayfield, McLeod, \& Hall, 1974). Heavy/at-risk drinking will be defined in terms of consumption (7+/14+ drinks per week and/or 3+/4+ drinks on one occasion over the past week for women and men, respectively; USDHHS, 2005) and score on the Alcohol Use Disorders Identification Test (AUDIT score of 8-19; Babor, Higgins-Biddle, Saunders, \& Monteiro, 2001). A score between 8-19 on the AUDIT is indicative of heavy use while scores 20 and above are indicative of a more severe alcohol use disorder (i.e., "dependence", DSM-IV; APA, 2013; APA, 2000). Participants will be recruited through online advertisements on Craigslist, social media websites, and "Quickie Job Board" listings on student websites as well as via flyers in community and student health centers. Upon responding to advertisements participants will be administered a phone screen or complete online screening survey to determine study eligibility.
If eligible, baseline assessments will be administered at an in person appointment, including self-report assessments about alcohol use, drug use, consequences, and alcohol craving. Participants will complete a baseline fMRI scan, which involves administration of two versions of an alcohol cue reactivity (CR) task. Both CR tasks administered in the scanner will consist of a block design. The first alcohol CR task consists of two types of blocks-1) alcohol and 2) neutral beverage (i.e., soft drinks, juice, water). Subjects will be presented with 40 alcohol images and 40 neutral beverage images, respectively. The second task, the cued-CR task, involves 3 blocks utilizing the same images as the alcohol-CR task. Subjects will receive instructions regarding their reaction to the photos-1) INHIBIT CR (alcohol images), 2) INHIBIT NEUTRAL (neutral beverage images), and 3) INDULGE CR (alcohol images). More specifically, participants will be given the instruction to imagine each image is available to them and to either inhibit their natural reaction to the images presented (alcohol in one block, neutral beverages in another block) or think about the possibility of consuming, in this moment, each (alcohol-containing) beverage shown. This task was inspired by fMRI studies using CR tasks and cognitive restraint strategies to inhibit cravings for food and/or alcohol (Naqvi et al., 2015; Yokum \& Stice, 2013). For both tasks, each image will be presented for 4 seconds followed by a 2 second inter-image interval. Participants will be asked to rate their level of craving after each block for the first task only. Following this baseline scan, participants will complete a brief web-based intervention for alcohol use, Rethinking Drinking: Alcohol and Your Health (NIAAA, 2015), and will subsequently be randomized to either cognitive bias modification (CBM) or sham training. They will complete the first session of either CBM or sham training after randomization as well as an additional 4 CBM/sham sessions at home (via web) over one week following baseline. Participants will return to the lab one-week following their baseline appointment. At follow-up assessment, participants will complete all baseline assessment measures in addition to a second fMRI session consisting of the same CR tasks. Finally, participants will be emailed a link to a web-based survey at 1- and 6-months following baseline to assess drinking behavior. Data analysis will employ region of interest (ROI) analysis. Predefined ROIs include the bilateral amygdala, nucleus accumbens (NAcc), and dorsolateral and medial prefrontal cortex (dlPFC and mPFC). Anatomical ROIs will be generated using the Wake Forest University (WFU) Pickatlas automatic anatomical labeling tool (Maldjian, Laurienti, Kraft, \& Burdette, 2003) available for SPM. The analytic plan for testing study hypotheses are as follows: Primary Aim 1-For the alcohol CR task, two within subject contrasts will be calculated-1] alcohol CR > neutral CR pre-CBM/sham and 2] (alcohol CR > neutral CR) pre-CBM/sham - (alcohol CR > neutral CR) post-CBM/sham-in pre-defined ROIs. Primary Aim 2-as with the alcohol CR task, the within subject contrasts will be 1] INDULGE CR > INHIBIT CR pre-CBM/sham and 2] (INDULGE CR > INHIBIT CR) pre-CBM/sham - (INDULGE CR > INHIBIT CR) post-CBM/sham. Similar within subject contrasts will be explored for INHIBIT CR and INHIBIT NEUTRAL CR as a control. T-tests will be used to compare within subject contrasts for each task as well as to compare between-group contrasts (i.e., alcohol CR and INHIBIT CR pre-and post- CBM/sham). Secondary Aim: Correlations will be run to determine whether BL BOLD activity in each ROI significantly correlate with behavioral measures for both BL and 1-week follow-up. For significant correlations, pre- and post-CBM/sham difference scores will be calculated for behavioral measures and then correlated with significant BOLD contrasts representing change in neural activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be 2 groups- treatment group and control group. Both groups will receive a web-based motivational intervention then will be randomized to Cognitive Bias Modification or Sham (control) training. Participants will complete a total of 5 sessions of CBM or Sham over the course of a week.
| Arm | Type | Receives |
|---|---|---|
| CBM Group | Experimental | Behavioral: Cognitive Bias ModificationThis group will receive Cognitive Bias Modification training |
| Control Group | Sham comparator | Behavioral: Sham TrainingThis group will receive Sham (control) training |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- current hazardous drinking (score of 8+ on USAUDIT-C)
- interest in changing drinking
- English-speaking
- able to provide informed consent
Key exclusion criteria (10 listed)
- Score of 25+ on USAUDIT
- current or past treatment for alcohol or drug use
- lifetime diagnosis of other substance use disorder
- self-reported weekly or more other drug use as indicated on the NIDA-modified Alcohol, Smoking, and Substance Involvement Screening Test
- history of head injury or loss of consciousness
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 |
|---|---|---|
| Cognitive Bias ModificationCBM sessions are computer tasks that take 15 minutes each. CBM is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when "pulled" and will get smaller as if moving away when "pushed". CBM will involve pushing 90% of alcohol stimuli (pulling 10%) and pulling 90% of neutral stimuli (pushing 10%). | Behavioural | CBM Group |
| Sham TrainingSham training sessions are computer tasks that take 15 minutes each. Sham training is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when "pulled" and will get smaller as if moving away when "pushed". Sham training will involve pushing and pulling 50% of each type of stimuli (alcohol and neutral) | Behavioural | Control Group |
Primary outcome
Blood Oxygen Level Dependent (BOLD) Signal Change
Time frame: 1-week
Blood oxygen level dependent (BOLD) signal change in ROIs [amygdala, nucleus accumbent (NAcc), medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (dlPFC) during alcohol cue-reactivity decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
BOLD Signal Change in ROIs (Amygdala, NAcc, mPFC, dlPFC) During INHIBIT Cue-reactivity
Time frame: 1-week
Decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
BOLD Signal Change in ROIs (Amygdala, NAcc, mPFC) During INDULGE Cue-reactivity
Time frame: 1-week
Decreased BOLD signal change in ROIs indicates better outcomes for amygdala, NAcc, and mPFC
5 secondary outcomes
Drinking Behavior
Time frame: 1-week
Drinking Behavior
Time frame: 1-month
Drinking Behavior
Time frame: 6-months
Alcohol Craving
Time frame: 1-week
Alcohol Craving
Time frame: 1-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kelli Tahaney, M.A. principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification in people with Alcohol Drinking, run by Boston University Charles River Campus 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Oct 2026. 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 2 Oct 2026). 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?
Blood Oxygen Level Dependent (BOLD) Signal Change (time frame: 1-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.