Alcohol AbuseNCT03648840
Human Alcohol Seeking Despite Aversion
A study testing Aversive Cue and Neutral Cue in people with Alcohol Abuse, run by Indiana University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Aversive Cue and Neutral Cue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 4 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women age 21-55
- Range of lifetime alcohol drinking history from 25 kg to 500 kg, with preference for extremes, plus recent drinking at least 7 drinks/week (women) and 20 drinks/week (men)
- Able to understand and complete questionnaires and procedures in English
- Willing and able to tolerate iv placement
- Right-handed (for fMRI Arm only)
Who cannot join
- Pregnant or breast-feeding
- Seeking or in treatment for substance use disorder or under court ordered abstinence
- Medications, medical disorders or conditions that could affect study outcome or subject safety
- Positive urine drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine
- Positive breath alcohol (BrAC) reading on arrival at any study visit
- Actively suicidal (within previous year)
- Left-handed or ambidextrous (for fMRI Arm only)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Alcohol Abuse
- Being tested
- Aversive Cue, Neutral Cue
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aversive CueBehavioural
Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol
Neutral CueBehavioural
Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol
| Study group | Role | What they receive |
|---|---|---|
| Higher lifetime alcohol drinking | Experimental | Participants with a history of higher lifetime alcohol consumption Receives: Behavioral: Aversive Cue; Behavioral: Neutral Cue |
| Lower lifetime alcohol drinking | Experimental | Participants with a lower lifetime alcohol consumption Receives: Behavioral: Aversive Cue; Behavioral: Neutral Cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: In two infusion sessions, to occur 5-14 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start4 Apr 2018
- Primary completion4 May 2022
- Study completion4 May 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2 session crossover, random order, single blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Martin Plawecki, Indiana University
- Investigators
- Martin H Plawecki, MD, PhD, Principal investigator, Psychiatry, Indiana University School of MedicineMelissa A Cyders, PhD, Principal investigator, Psychology, Indiana University-Purdue University at Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648840
- Sponsor's protocol ID
- 1709318986
- Other IDs
- P60AA007611
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2018
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40618299
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Alcohol Seeking Despite Aversion
- ClinicalTrials.gov ID
- NCT03648840
- Acronym / sponsor ID
- 1709318986
- Conditions
- Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 session crossover, random order, single blind
| Arm | Type | Receives |
|---|---|---|
| Higher lifetime alcohol drinking | Experimental | Behavioral: Aversive Cue, Behavioral: Neutral CueParticipants with a history of higher lifetime alcohol consumption |
| Lower lifetime alcohol drinking | Experimental | Behavioral: Aversive Cue, Behavioral: Neutral CueParticipants with a lower lifetime alcohol consumption |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women age 21-55
- Range of lifetime alcohol drinking history from 25 kg to 500 kg, with preference for extremes, plus recent drinking at least 7 drinks/week (women) and 20 drinks/week (men)
- Able to understand and complete questionnaires and procedures in English
- Willing and able to tolerate iv placement
- Right-handed (for fMRI Arm only)
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding
- Seeking or in treatment for substance use disorder or under court ordered abstinence
- Medications, medical disorders or conditions that could affect study outcome or subject safety
- Positive urine drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine
- Positive breath alcohol (BrAC) reading on arrival at any study visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aversive CueParticipants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol | Behavioural | Higher lifetime alcohol drinking, Lower lifetime alcohol drinking |
| Neutral CueParticipants will be exposed to neutral pictures and tones during performance of a task to earn alcohol | Behavioural | Higher lifetime alcohol drinking, Lower lifetime alcohol drinking |
Primary outcome
The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration
Time frame: In two infusion sessions, to occur 5-14 days apart
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40618299Garrison 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin H Plawecki, MD, PhD principal investigator
Psychiatry, Indiana University School of Medicine
Melissa A Cyders, PhD principal investigator
Psychology, Indiana University-Purdue University at Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aversive Cue and Neutral Cue in people with Alcohol Abuse, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration (time frame: In two infusion sessions, to occur 5-14 days apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.