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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04430543
Study groupRoleWhat they receive
CBM GroupExperimentalThis group will receive Cognitive Bias Modification training
Receives: Behavioral: Cognitive Bias Modification
Control GroupSham comparatorThis 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.

  1. 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

  2. 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

  3. 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)
  1. Drinking Behavior

    Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome

    Measured: 1-week

  2. Drinking Behavior

    Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome

    Measured: 1-month

  3. Drinking Behavior

    Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome

    Measured: 6-months

  4. 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

  5. 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.

  1. First posted12 Jun 2020
  2. Study start21 Aug 2019
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Why it stopped: Study terminated early due to COVID -19 and subsequent inability to run subjects at the facility.

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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