Trial Outcomes & Findings for Human Alcohol Seeking Despite Aversion (NCT NCT03648840)

Last Updated: 2025-02-25

Results Overview

Participants earn 2.5 min exposures to an increase in iv infusion rate (causing a prescribed increase in breath alcohol concentration (BRAC)) by completing repetitions of a constant attention button-pressing task (CAT). The task is designed so that the number of correct CAT trials required increases progressively from 1 (for the first drink) to 380 (for the 20th drink) on an accelerating scale. The dependent measure Breakpoint is defined as the cumulative number of correct and incorrect CAT trials completed when the last drink is earned; in the time allowed possible values ranged from 1 to 800. Effect of the Aversive cue was assessed by calculating a difference score (Breakpoint Aversive Cue-Breakpoint Neutral Cue); the range of possible difference scores was -800 to +800. A positive difference score indicates a higher breakpoint (more alcohol earned) in the Aversive Cue session; a negative number indicates a lower breakpoint (less alcohol earned).

Recruitment status

TERMINATED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

In two infusion sessions, to occur 5-14 days apart

Results posted on

2025-02-25

Participant Flow

Participants were recruited from the general public local to Indianapolis, Indiana. Recruiting methods included flyering, ads run in local publications, and word of mouth. Recruiting period ran from January, 2018 to July, 2022.

Participant milestones

Participant milestones
Measure	Aversive Cue First, Then Neutral Cue Participants could earn brief increases in breath alcohol concentration by performing an attention task during two 3-hour IV alcohol infusion sessions scheduled 5-14 days apart. During the Aversive Cue session, participants were exposed to unpleasant pictures and tones during the attention task. During the Neutral Cue session, participants were exposed to neutral pictures and tones during the attention task. Session order was randomly assigned.	Neutral Cue First, Then Aversive Cue Participants could earn brief increases in breath alcohol concentration by performing an attention task during two 3-hour IV alcohol infusion sessions scheduled 5-14 days apart. During the Aversive Cue session, participants were exposed to unpleasant pictures and tones during the attention task. During the Neutral Cue session, participants were exposed to neutral pictures and tones during the attention task. Session order was randomly assigned.
First IV Infusion Session STARTED	39	48
First IV Infusion Session COMPLETED	39	46
First IV Infusion Session NOT COMPLETED	0	2
Session 1 to Session 2 Interval STARTED	39	46
Session 1 to Session 2 Interval COMPLETED	39	45
Session 1 to Session 2 Interval NOT COMPLETED	0	1
Second IV Infusion Session STARTED	39	45
Second IV Infusion Session COMPLETED	39	45
Second IV Infusion Session NOT COMPLETED	0	0
Session 2 to Imaging Interval STARTED	39	45
Session 2 to Imaging Interval COMPLETED	28	29
Session 2 to Imaging Interval NOT COMPLETED	11	16
fMRI Session STARTED	28	29
fMRI Session COMPLETED	28	29
fMRI Session NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Aversive Cue First, Then Neutral Cue Participants could earn brief increases in breath alcohol concentration by performing an attention task during two 3-hour IV alcohol infusion sessions scheduled 5-14 days apart. During the Aversive Cue session, participants were exposed to unpleasant pictures and tones during the attention task. During the Neutral Cue session, participants were exposed to neutral pictures and tones during the attention task. Session order was randomly assigned.	Neutral Cue First, Then Aversive Cue Participants could earn brief increases in breath alcohol concentration by performing an attention task during two 3-hour IV alcohol infusion sessions scheduled 5-14 days apart. During the Aversive Cue session, participants were exposed to unpleasant pictures and tones during the attention task. During the Neutral Cue session, participants were exposed to neutral pictures and tones during the attention task. Session order was randomly assigned.
First IV Infusion Session Adverse Event	0	2
Session 1 to Session 2 Interval Pandemic	0	1
Session 2 to Imaging Interval Participant declined fMRI at enrollment	8	11
Session 2 to Imaging Interval MRI exclusion (left handed)	3	5

Baseline Characteristics

Human Alcohol Seeking Despite Aversion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Higher Lifetime Alcohol Drinking n=42 Participants Participants with a history of higher lifetime alcohol consumption will complete 2 IV alcohol infusion sessions that include aversive or neutral cues.	Lower Lifetime Alcohol Drinking n=45 Participants Participants with a history of lower lifetime alcohol consumption will complete 2 IV alcohol infusion sessions that include aversive or neutral cues.	Total n=87 Participants Total of all reporting groups
Age, Continuous	33.3 Years STANDARD_DEVIATION 10.8 • n=5 Participants	30.6 Years STANDARD_DEVIATION 10.5 • n=7 Participants	31.9 Years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	44 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: In two infusion sessions, to occur 5-14 days apart

Population: Between subjects design

Outcome measures

Outcome measures
Measure	Higher Lifetime Alcohol Drinking n=41 Participants Lifetime drinking history is estimated using lifetime drinks per drinking day using a time-line follow back method. Higher and lower drinking groups are defined using the NIH-NIAAA standard: For the Higher drinking group, average lifetime drinks per drinking day was \>= 4 for women and 5 for men; for the lower drinking group, average lifetime drinks per drinking day was \<4 for women and \<5 for men	Lower Lifetime Alcohol Drinking n=43 Participants Lifetime drinking history is estimated using lifetime drinks per drinking day using a time-line follow back method. Higher and lower drinking groups are defined using the NIH-NIAAA standard: For the Higher drinking group, average lifetime drinks per drinking day was \>= 4 for women and 5 for men; for the lower drinking group, average lifetime drinks per drinking day was \<4 for women and \<5 for men
The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration	-6.0 Units on a scale Standard Error 8.6	7.3 Units on a scale Standard Error 6.9

Adverse Events

Aversive Cue

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Neutral Cue

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

fMRI

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aversive Cue n=84 participants at risk Participants who completed part or all of the Aversive Cue session	Neutral Cue n=87 participants at risk Participants who completed part or all of the Neutral Cue session	fMRI n=57 participants at risk Participants who completed part or all of the fMRI session
Injury, poisoning and procedural complications IV pain	1.2% 1/84 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.	1.1% 1/87 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/57 • From enrollment to end of the final study day, usually about 8 weeks.
Injury, poisoning and procedural complications Nausea	1.2% 1/84 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.	3.4% 3/87 • Number of events 3 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/57 • From enrollment to end of the final study day, usually about 8 weeks.
Injury, poisoning and procedural complications Upset by aversive images	1.2% 1/84 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/87 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/57 • From enrollment to end of the final study day, usually about 8 weeks.
General disorders Claustrophobia	0.00% 0/84 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/87 • From enrollment to end of the final study day, usually about 8 weeks.	1.8% 1/57 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.
General disorders Discomfort	0.00% 0/84 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/87 • From enrollment to end of the final study day, usually about 8 weeks.	1.8% 1/57 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.
Nervous system disorders Nerve Stimulation	0.00% 0/84 • From enrollment to end of the final study day, usually about 8 weeks.	0.00% 0/87 • From enrollment to end of the final study day, usually about 8 weeks.	1.8% 1/57 • Number of events 1 • From enrollment to end of the final study day, usually about 8 weeks.

Additional Information

Dr. Martin H. Plawecki, MD, PhD

Indiana University - Indianapolis

Phone: 317 944 8164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place