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| ID | Type | Description | Link |
|---|---|---|---|
| P60AA007611 | U.S. NIH Grant/Contract | View source |
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Enrollment paused when our alcohol supplier recalled and suspended manufacture of the product. When production resumed, there was not enough time remaining to successfully resume recruitment. We will examine the outcomes with the existing sample.
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| Name | Class |
|---|---|
| Purdue University | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Prolonged alcohol use results in drinking despite resultant problems and adverse consequences. The investigators propose to test a laboratory model of human seeking despite aversion to use as an early marker of disease onset, and as a tool for study of its neural functional substrates, and identification of effective treatments.
The long-term goal for this project is to establish a model of alcohol seeking despite aversion (SDA) as a platform for the laboratory testing of novel pharmacologic and behavioral interventions that can be used among those with the highest risk, but who have yet to progress to treatment-resistant drinking. The objective of this application is to test SDA across multiple levels of analysis. The investigators consider SDA as an early marker of alcohol use disorder progression that is related to lifetime drinking history, alcohol use disorder risks, and brain physiology. The investigators have completed a pilot study demonstrating that SDA can be objectively quantified via an intravenous alcohol self-administration task, in which operant work for identical incremental alcohol rewards is paired with aversive stimuli. This preliminary data supports the central hypotheses that behavior in the SDA model is attributable to lifetime alcohol exposure, is related to alcohol use disorder risk factors and phenotypes, and reflects alterations in neural system function. In this project, SDA will be measured along with recent and lifetime drinking history, negative affect-based rash action (i.e. negative urgency, including action with respect to alcohol use), and self-rating of the effects of alcohol. The rationale for this work is that it would lead to the first objective, well-validated measure of SDA in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher lifetime alcohol drinking | Experimental | Participants with a history of higher lifetime alcohol consumption |
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| Lower lifetime alcohol drinking | Experimental | Participants with a lower lifetime alcohol consumption |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aversive Cue | Behavioral | Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol |
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| Measure | Description | Time Frame |
|---|---|---|
| The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration | 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). | In two infusion sessions, to occur 5-14 days apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin H Plawecki, MD, PhD | Psychiatry, Indiana University School of Medicine | Principal Investigator |
| Melissa A Cyders, PhD | Psychology, Indiana University-Purdue University at Indianapolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40618299 | Derived | Garrison ACS, Wu W, Cox MR, Haines D, Hays J, Mlungwana MK, Kosobud AEK, Kareken DA, O'Connor S, Plawecki MH, Cyders MA. Aversion-resistant alcohol seeking in the human laboratory. Alcohol Clin Exp Res (Hoboken). 2025 Jul;49(7):1518-1529. doi: 10.1111/acer.70078. Epub 2025 Jul 6. |
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After publication of the main findings, a de-identified dataset will be made available through direct requests as described above; a statement to this effect will be included in all published manuscripts.
The current proposal utilizes the Seeking Despite Aversion Task, a newly developed Computer-Assisted Infusion System (CAIS) protocol that integrates delivery of visual stimuli into the Constant Attention Task and optical markers for evoked response potential generation. This task, like other CAIS protocols, will become part of the portfolio of CAIS programs that our lab makes available to other scientists once our specific funded use of this protocol is completed. Modified versions of this protocol could be provided to other investigators prior to completion of this project as long as these projects do not directly compete.
Data will become available following final publication of all manuscripts by the component investigators. Earliest date is estimated to be January, 2025.
Data and Resource Sharing Plan - Indiana Alcohol Research Center (IARC)
Consistent with its past history, the IARC continues to make available its data and resources to investigators engaged in alcoholism research outside of Indiana University. Detailed procedures are available on request. In brief, investigators must submit a written request specifying in adequate detail the specific resource(s) required and a study protocol indicating the specific aims, scientific rationale, methods and procedure, and analysis of results; a signed IARC Resource Utilization Agreement Form; and for studies involving human subjects, Institutional Review Board (IRB) approval if needed for the proposed study. The request will be reviewed by the IARC Steering Committee. Investigators must agree to acknowledge the Indiana Alcohol Research Center (P60 AA007611) as the source of the resource in all resulting publications.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First IV Infusion Session |
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| Session 1 to Session 2 Interval |
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| Second IV Infusion Session |
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| Session 2 to Imaging Interval |
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| fMRI Session |
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The planned primary outcome, reported below, is a comparison between participants with higher versus lower lifetime alcohol drinking. Therefore, baseline characteristics are provided for participants within these two groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Higher Lifetime Alcohol Drinking | Participants with a history of higher lifetime alcohol consumption will complete 2 IV alcohol infusion sessions that include aversive or neutral cues. |
| BG001 | Lower Lifetime Alcohol Drinking |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration | 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). | Between subjects design | Posted | Mean | Standard Error | Units on a scale | In two infusion sessions, to occur 5-14 days apart |
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From enrollment to end of the final study day, usually about 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aversive Cue | Participants who completed part or all of the Aversive Cue session |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV pain | Injury, poisoning and procedural complications | Non-systematic Assessment | IV pain during infusions is an anticipated risk |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin H. Plawecki, MD, PhD | Indiana University - Indianapolis | 317 944 8164 | mplaweck@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2022 | Oct 1, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2020 | Feb 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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2 session crossover, random order, single blind
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Subjects are not informed which session will include aversive cues.
| Neutral Cue | Behavioral | Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol |
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| NOT COMPLETED |
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Participants with a history of lower lifetime alcohol consumption will complete 2 IV alcohol infusion sessions that include aversive or neutral cues.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Title |
|---|
| Description |
|---|
| OG000 | Higher Lifetime Alcohol Drinking | 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 |
| OG001 | Lower Lifetime Alcohol Drinking | 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 |
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|
| 0 |
| 84 |
| 0 |
| 84 |
| 3 |
| 84 |
| EG001 | Neutral Cue | Participants who completed part or all of the Neutral Cue session | 0 | 87 | 0 | 87 | 4 | 87 |
| EG002 | fMRI | Participants who completed part or all of the fMRI session | 0 | 57 | 0 | 57 | 3 | 57 |
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| Nausea | Injury, poisoning and procedural complications | Non-systematic Assessment | Nausea is an anticipated risk of iv infusion of alcohol solutions |
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| Upset by aversive images | Injury, poisoning and procedural complications | Non-systematic Assessment | One subject was upset by the aversive images shown, but chose to continue the session after a short break |
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| Claustrophobia | General disorders | Non-systematic Assessment | Claustrophobia in the scanner is an anticipated risk |
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| Discomfort | General disorders | Non-systematic Assessment | General discomfort in scanner is an anticipated risk |
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| Nerve Stimulation | Nervous system disorders | Non-systematic Assessment | Nerve stimulation during imaging is an anticipated risk |
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