Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04430543 |
| Other study ID # |
4633E |
| Secondary ID |
1F31AA025522-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 21, 2019 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
Boston University Charles River Campus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
