Clinical trial NCT04924283: Cognitive Interference Task on Alcohol Craving and Consumption
Official title: Effects of a Cognitive Interference Task on Alcohol Craving and Consumption Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Craving
Keywords: ecological momentary assessment
cognitive interference
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-06-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test a brief task of playing the game Tetris to reduce alcohol cravings and alcohol use. Women who are seen at primary care and recruited through the community will be asked to rate alcohol craving and use for a 1-week baseline period. Then they will be randomly assigned to play the Tetris game on their phones daily or to a control condition for a 2-week period. Participants will also complete a cue-reactivity task, that involves viewing pictures of alcohol and rating cravings.


Eligibility criteria: Inclusion Criteria:

1. Female, any race or ethnicity, age 21 to 65 years old.
2. Able to comprehend English.
3. At least one heavy drinking per week (i.e., consuming at least four or more drinks in one day) for the last two weeks
4. Internet access and reliable electronic device

Exclusion Criteria:

1. More than four heavy drinking days per week.
2. Currently engaged in treatment for Alcohol Use Disorder (AUD).
3. Current clinically significant bipolar affective disorder, schizophrenia, or psychotic disorder.
4. Pregnant.
5. Imminently suicidal or homicidal.
6. Participants taking psychoactive medications that may affect alcohol craving or consumption.
7. A score of 10 or higher on the Clinical Institute of Alcohol Withdrawal Revised (CIWA-R).24

Primary outcomes:
measure: Alcohol Craving
timeFrame: Participants reported cravings one-month after the intervention.
measure: Average Drinks Per Occasion
timeFrame: Participants reported alcohol consumption one month after the intervention.
measure: Number of Standard Drinks
timeFrame: Participants reported number of standard drinks each morning at a scheduled time for 14 days.
measure: Changes in Alcohol Craving Before and After Tetris Task
timeFrame: Participants reported pre- and post-task alcohol craving up to three times per day for a 14-day intervention period. Post-task craving was measured right after the Tetris task/control break and pre-task craving was measured directly before.
measure: Changes in Alcohol Craving Before and After Cue Tetris Task
timeFrame: Participants reported pre- and post-task alcohol craving up to once a day for a 14-day intervention period. Post-task craving was measured right after the CREMA/wait period and pre-task craving was measured directly before.
Secondary outcomes:
measure: Obsessive Thoughts About Alcohol
timeFrame: Participants reported obsessive thoughts about alcohol at a single baseline assessment, which occurred the day before the EMA period began.
measure: Drinking Motives
timeFrame: Participants reported drinking motives at baseline.
measure: Feasibility of Intervention
timeFrame: This was recorded during the 14-day intervention phase.
measure: Acceptability Ratings
timeFrame: Recorded within one-week after the intervention.
Other outcomes:
measure: Mood Ratings
timeFrame: This will be recorded during the intervention phase.
measure: Stress Ratings
timeFrame: This will be recorded during the intervention phase.
measure: Depression Symptoms
timeFrame: Participants reported depression symptoms at baseline.
measure: Post-traumatic Stress Disorder Symptoms
timeFrame: Participants reported posttraumatic stress symptoms at baseline.
measure: Alcohol Use Disorder Symptoms at Baseline
timeFrame: Participants reported self-reported symptoms of alcohol use disorder at baseline.
measure: Alcohol Use Disorder at Baseline
timeFrame: Participants reported alcohol use disorder symptoms at baseline.
measure: COVID-19 Related Stress at Baseline
timeFrame: Participants reported COVID-19 related stress at baseline.
measure: Impulsivity at Baseline
timeFrame: Participants reported impulsivity at baseline.
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: