Alcohol Use DisorderPhase 1SPARNCT03827460
Sex Differences in the Response to Abstinence From Alcohol.
A Phase 1 study testing Abstinence from alcohol, Usual drinking and Intravenous Alcohol in people with Alcohol Use Disorder, run by Indiana University at 1 site in United States.
Trial summary
In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Abstinence from alcohol, Usual drinking and Intravenous Alcohol
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 28 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Moderate social drinkers
- Able to understand/complete questionnaires and procedures in English
- Body mass index (BMI) between 18.5 and 32 kg/m2
- Have venous access sufficient to allow blood sampling
Who cannot join
- Pregnant or breast-feeding women, or women who intend to become pregnant
- Do not attest to using accepted forms of birth control for the infusion phase of the study
- Current treatment for, or desire to be treated for, any substance use disorder or court ordered to not drink alcohol
- History of significant adverse reaction to alcohol
- Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety
- Medications (past 30 days) that could influence data or participant safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by investigators
Show all 10Show fewer
- DSM 5 Disorders (non AUD) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness
- Positive breath alcohol reading on arrival at any study visit
- Actively suicidal (for example, any suicide attempts within the past year or any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the investigator
- Any condition for which the principal investigators determine it is unsafe or not prudent to enroll
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospital
Indianapolis, Indiana, 46202
Study Recruiter, 317-948-6551, erptest@iupui.edu
Martin H Plawecki, MD, PhD
About this study
In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. In the present study, the investigators propose to study how men and women respond to abstinence, and whether this information can be used to improve intervention and prevention strategies.
Read the detailed description
Women and men differ in how quickly they progress from social to problematic alcohol drinking. In laboratory animals, short-term abstinence increases alcohol consumption, with repeated deprivations leading to disordered drinking. In a preliminary study, the investigators found that men and women differed in how their motivation to drink alcohol changed after a short period of abstinence. The investigators hypothesize that this difference may affect their transition to alcohol use disorders. The objectives of this application are to characterize the human post abstinence response, and use identical alcohol exposures to study the mechanisms underlying identified sex differences. In addition, the investigators will complete a 2 year prospective study of natural drinking patterns to assess how self-reported abstinence intervals influence drinking trajectories. The long-term goal of this project is to inform alcohol use disorder treatment and to design and test novel interventions using the laboratory model of post-abstinence response. There is a critical unfilled need to understand sex differences in disease progression, and this lab-based assessment coupled to longitudinal follow-up provides the rigorous experimental design to begin to meet that need. This project will increase scientific knowledge by advancing the translation between preclinical and clinical models, eventually informing sex-specific intervention and prevention strategies for problematic drinking and establishing a model to test those interventions..
- Conditions
- Alcohol Use Disorder
- Being tested
- Abstinence from alcohol, Usual drinking, Intravenous Alcohol
- Keywords
- Alcohol, Alcoholism, Sex Differences, Abstinence, Alcohol Deprivation Effect
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence from alcoholBehavioural
Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol
Usual drinkingBehavioural
Participants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior
Intravenous AlcoholDrug
Also called 6.0& (v/V) ethanol solution
During the laboratory alcohol infusion sessions, alcohol is infused through an indwelling catheter.
| Study group | Role | What they receive |
|---|---|---|
| Free access alcohol self-administration | Experimental | During the 2.5-hour free-access self-administration sessions, the participant may choose to complete a task for an alcohol or water reward. Interventions include Abstinence from Alcohol and Usual Drinking Receives: Behavioral: Abstinence from alcohol; Behavioral: Usual drinking; Drug: Intravenous Alcohol |
| Clamped alcohol exposure | Experimental | A battery of behavioral tasks will be administered to participants before, and at the beginning and end of a 3 hour clamped exposure to alcohol (fixed at 80 mg/dL). EEG will be recorded throughout to assess event related potentials associated with task performance. Interventions include Abstinence from Alcohol and Usual Drinking. Receives: Behavioral: Abstinence from alcohol; Behavioral: Usual drinking; Drug: Intravenous Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex differences in the effect of abstinence on alcohol self-administration.
The effect of 2 weeks abstinence on intravenous alcohol intake will be compared in men and women.
Measured: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.
The effect of 2 weeks abstinence from alcohol on sensitivity of the neurophysiological P3 response to alcohol, assessed using a stop-signal response task, will be compared in women and men during an iv infusion clamp.
Measured: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Sex differences in the effect of abstinence on subjective responses to alcohol.
The effect of 2 weeks abstinence from alcohol on subjective responses to alcohol in women and men will be assessed using a survey during an iv infusion clamp.
Measured: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The role of changes in alcohol elimination on sex differences in response to abstinence.
The effect of 2 weeks abstinence from alcohol on alcohol elimination in men and women will be assessed using an iv alcohol infusion clamp.
Measured: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Secondary outcomes (1)
Response to abstinence as a predictor of alcohol risk in women and men.
For both Arm 1 and Arm 2, daily alcohol consumption will be surveyed every 2 months for 2 years following the laboratory sessions. Self-imposed periods of abstinence will be assessed to determine if subsequent daily alcohol intake increases or decreases, and to determine if men and women differ in the effect of abstinence on drinking.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start10 Apr 2019
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arms 1 and 2: 2 session parallel, random order, no blind.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT03827460
- Sponsor's protocol ID
- 1809467722
- Other IDs
- R01AA027236-05
- Acronym
- SPAR
- Status last verified
- Nov 2026
- First submitted
- 12 Nov 2018
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final raw dataset will be available to other researchers when we have collected all subjects and completed our own planned analyses. Prior to completion of our own planned analyses, we would be willing to consider releasing the dataset upon request. We will work with our IRB to establish a strategy for de-identifying the data while retaining the ability to ensure the quality of the stored data, and develop a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in the Response to Abstinence From Alcohol.
- ClinicalTrials.gov ID
- NCT03827460
- Acronym / sponsor ID
- SPAR / 1809467722
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Alcoholism, Sex Differences, Abstinence, Alcohol Deprivation Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. In the present study, the investigators propose to study how men and women respond to abstinence, and whether this information can be used to improve intervention and prevention strategies.
Detailed description
Women and men differ in how quickly they progress from social to problematic alcohol drinking. In laboratory animals, short-term abstinence increases alcohol consumption, with repeated deprivations leading to disordered drinking. In a preliminary study, the investigators found that men and women differed in how their motivation to drink alcohol changed after a short period of abstinence. The investigators hypothesize that this difference may affect their transition to alcohol use disorders. The objectives of this application are to characterize the human post abstinence response, and use identical alcohol exposures to study the mechanisms underlying identified sex differences. In addition, the investigators will complete a 2 year prospective study of natural drinking patterns to assess how self-reported abstinence intervals influence drinking trajectories. The long-term goal of this project is to inform alcohol use disorder treatment and to design and test novel interventions using the laboratory model of post-abstinence response. There is a critical unfilled need to understand sex differences in disease progression, and this lab-based assessment coupled to longitudinal follow-up provides the rigorous experimental design to begin to meet that need. This project will increase scientific knowledge by advancing the translation between preclinical and clinical models, eventually informing sex-specific intervention and prevention strategies for problematic drinking and establishing a model to test those interventions..
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arms 1 and 2: 2 session parallel, random order, no blind.
| Arm | Type | Receives |
|---|---|---|
| Free access alcohol self-administration | Experimental | Behavioral: Abstinence from alcohol, Behavioral: Usual drinking, Drug: Intravenous AlcoholDuring the 2.5-hour free-access self-administration sessions, the participant may choose to complete a task for an alcohol or water reward. Interventions include Abstinence from Alcohol and Usual Drinking |
| Clamped alcohol exposure | Experimental | Behavioral: Abstinence from alcohol, Behavioral: Usual drinking, Drug: Intravenous AlcoholA battery of behavioral tasks will be administered to participants before, and at the beginning and end of a 3 hour clamped exposure to alcohol (fixed at 80 mg/dL). EEG will be recorded throughout to assess event related potentials associated with task performance. Interventions include Abstinence from Alcohol and Usual Drinking. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate social drinkers
- Able to understand/complete questionnaires and procedures in English
- Body mass index (BMI) between 18.5 and 32 kg/m2
- Have venous access sufficient to allow blood sampling
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding women, or women who intend to become pregnant
- Do not attest to using accepted forms of birth control for the infusion phase of the study
- Current treatment for, or desire to be treated for, any substance use disorder or court ordered to not drink alcohol
- History of significant adverse reaction to alcohol
- Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety
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 |
|---|---|---|
| Abstinence from alcoholParticipants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol | Behavioural | Clamped alcohol exposure, Free access alcohol self-administration |
| Usual drinkingParticipants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior | Behavioural | Clamped alcohol exposure, Free access alcohol self-administration |
| Intravenous AlcoholAlso: 6.0& (v/V) ethanol solutionDuring the laboratory alcohol infusion sessions, alcohol is infused through an indwelling catheter. | Drug | Clamped alcohol exposure, Free access alcohol self-administration |
Primary outcome
Sex differences in the effect of abstinence on alcohol self-administration.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The effect of 2 weeks abstinence on intravenous alcohol intake will be compared in men and women.
Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The effect of 2 weeks abstinence from alcohol on sensitivity of the neurophysiological P3 response to alcohol, assessed using a stop-signal response task, will be compared in women and men during an iv infusion clamp.
Sex differences in the effect of abstinence on subjective responses to alcohol.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The effect of 2 weeks abstinence from alcohol on subjective responses to alcohol in women and men will be assessed using a survey during an iv infusion clamp.
The role of changes in alcohol elimination on sex differences in response to abstinence.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The effect of 2 weeks abstinence from alcohol on alcohol elimination in men and women will be assessed using an iv alcohol infusion clamp.
1 secondary outcome
Response to abstinence as a predictor of alcohol risk in women and men.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The final raw dataset will be available to other researchers when we have collected all subjects and completed our own planned analyses. Prior to completion of our own planned analyses, we would be willing to consider releasing the dataset upon request. We will work with our IRB to establish a strategy for de-identifying the data while retaining the ability to ensure the quality of the stored data, and develop a data-sharing agreement.
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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.
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 Phase 1 study testing Abstinence from alcohol, Usual drinking and Intravenous Alcohol in people with Alcohol Use Disorder, 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann E Kosobud, Ph.D. ((317) 274-0087, akosobud@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex differences in the effect of abstinence on alcohol self-administration. (time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.