Impulsivity Domains and Subjective Response

Alcohol Use Disorder Clinical Trial

Official title:

Linking Impulsivity Domains and Subjective Response to Alcohol in Young Adults Using Lab and Daily Assessment Methods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929677
• Other study ID #: 71127
• Secondary ID: R01AA029488
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Jessica Weafer, PhD
• Phone: 614-257-2075
• Email: jessica.weafer[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults.

Description:

Young adult alcohol misuse is an urgent, growing public health crisis, as young adults have the highest alcohol use disorder rates of any age group with rates increasing in young women. Interventions for this population are hampered by small effects, few options and lack of tailoring to salient risk factors. A recent review in Addiction argued that research informing interventions fails to account for the complexity of relationships among factors contributing to young adult alcohol misuse. These needs will be addressed by examining relationships between two cardinal etiologic risk factors: impulsivity and subjective response to alcohol (SR). Despite theoretical and biological links between them, little is known about relations between the two risk factors, or how associations between them may promote young adult alcohol misuse longitudinally and on a momentary or daily basis. Prior theory and evidence linking impulsivity and positive, rewarding alcohol effects have been primarily learning and expectancy based. Here, based on exciting preliminary results, the researchers posit an inherent, biological link between impulsivity and high-risk SR (elevated stimulation and dampened sedation). This research is nascent with multiple gaps in knowledge. These gaps will be addressed by examining impulsivity pre-drinking, SR and alcohol use in a lab setting and via seven 10-day daily assessment periods over 2 years using ecological momentary assessment (EMA) (N=250, 50% female). Using self-report and both lab and mobile tasks, the investigators will characterize 3 unique, established impulsivity domains: poor inhibitory control, delay discounting and negative urgency. SR will be assessed at successive breath alcohol levels using precision intravenous (IV) methods in the lab, followed by opportunity to self-administer more IV alcohol. SR will also be measured at roughly comparable, estimated blood alcohol levels via daily EMA methods. This design enables testing of SR early in a drinking event as a predictor of in-lab and daily alcohol use, along with alcohol use and consequences over time, plus SR's potential role as a mediator of impulsivity/alcohol relations. Recent findings indicate daily changes in impulsivity predict subsequent drinking and consequences. These types of changes are challenging to capture with lab methods only. Daily measures also enable modeling of both person-level individual differences and daily, within-subject effects. However, there are no published studies relating daily impulsivity and SR measures. In this study, investigators will: 1) determine relations between lab-based impulsivity and SR; 2) determine relations between daily impulsivity and SR; and 3) relate impulsivity and SR to alcohol misuse longitudinally.

Researchers hypothesize impulsivity will relate to heightened stimulation and less sedation following alcohol and that SR will partially mediate relations between impulsivity and alcohol misuse. Evidence of links between specific impulsivity domains and SR longitudinally and on a momentary/daily basis will point to specific intervention targets to ameliorate two critical vulnerability factors for young adult alcohol misuse. Thus, investigators will: 1) identify mechanisms of alcohol action and 2) facilitate prevention and treatment research: two NIAAA priority areas.

Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults. As such, the project is directly relevant to NIAAA's mission to identify mechanisms of alcohol action and facilitate prevention and treatment research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 25 Years

Eligibility

Inclusion Criteria:

• 21-25 years old

• Report drinking to an estimated BAC > .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB)

• Report drinking at least twice weekly in the past 30 days based on responses on the TLFB

• Fluency in English

Exclusion Criteria:

• Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)

• Body weight < 110 or > 210 pounds

• Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder

• Current alcohol withdrawal or history of medically-assisted detoxification

• Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment or experimental session

• Positive urine screen for illegal drugs other than cannabis

• Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors

• Current psychotropic medication use or receipt of a prescription for these medications in the past 30 days

• Psychosis or other psychiatric disability

• Pregnancy, nursing or lack of reliable birth control use for women

• Report smoking > 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Impulsive Behavior

Intervention

Drug:
• Placebo
Participants receive placebo (saline) intravenously. They will also have the opportunity to self-administer saline during the 60-minute free-access IV self-administration period in session 3.
• Alcohol
Participants receive alcohol intravenously, clamped at BrACs of 20mg%, 40mg%, and 60mg%. They will also have the opportunity to self-administer alcohol (up to 120mg% BrAC) during the 60-minute free-access IV self-administration period in session 3.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jessica Weafer	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lab Subjective Response to Alcohol (SR)	Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation).	70 minutes
Primary	Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)	Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation) using the EMA app.	10 days
Primary	Change in Breath Alcohol Concentration (BrAC)	Highest BrAC in mg% taken by breathalyzer during the free-access period	60 minutes
Primary	Number of alcohol drink units self administered	participants can self-administer alcohol infusions by pushing 1 of 2 buttons to receive an alcohol or water "drink" unit. Each alcohol "drink" targets a 7.5mg% increase in BrAC over 2.5 min. The water "drink" is an equal volume of saline.	60 minutes
Primary	Number of drinks per day	Participants will report the number of drinks they consume each day via EMA app added to their phone.	10 days