Alcohol Use DisorderPhase 2NCT05870111
Citicoline in Youth Alcohol Use Disorder
A Phase 2 study testing Citicoline (cytidine diphosphate-choline) in people with Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol. Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Citicoline (cytidine diphosphate-choline)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Feb 2029
- Phase
- Phase 2
- 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 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 to 22.
- Call study team for additional screening and information.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder
The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.
- Conditions
- Alcohol Use Disorder
- Being tested
- Citicoline (cytidine diphosphate-choline), Placebo oral capsule
- Keywords
- Citicoline
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline (cytidine diphosphate-choline)Drug
2000mg/day citicoline, administered orally, for 4 weeks
Placebo oral capsuleDrug
placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally
| Study group | Role | What they receive |
|---|---|---|
| Citicoline | Experimental | 2000mg/day citicoline for 4 weeks, administered orally Receives: Drug: Citicoline (cytidine diphosphate-choline) |
| Placebo | Placebo comparator | placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Cytokine: IL-1B
Peripheral cytokine (IL-1B) to measure neuroinflammation.
Measured: 4 weeks of treatment
Peripheral Cytokine: IL-6
Peripheral cytokine (IL-6) to measure neuroinflammation.
Measured: 4 weeks of treatment
Peripheral Cytokine: TNFα
Peripheral cytokine (TNFα) to measure neuroinflammation.
Measured: 4 weeks of treatment
Brain Metabolite: N-acetyl-aspartate
Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
Measured: 4 weeks of treatment
Brain Metabolite: Choline
Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
Measured: 4 weeks of treatment
Neurocognition: Behavioral impulsivity
Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
Measured: 4 weeks of treatment
Neurocognition: Cognitive Flexibility and Attention
Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
Measured: 4 weeks of treatment
Neurocognition: Inhibitory Control and Attention
Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.
Measured: 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Oct 2024
- Primary completion29 Apr 2026
- Study completionFeb 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 Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Squeglia, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870111
- Sponsor's protocol ID
- Pro00128800
- Status last verified
- May 2026
- First submitted
- 4 May 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05870111
- Acronym / sponsor ID
- Pro00128800
- Conditions
- Alcohol Use Disorder
- Keywords
- Citicoline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- Feb 2029 (estimated)
- First posted
- 23 May 2023 (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.
The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citicoline | Experimental | Drug: Citicoline (cytidine diphosphate-choline)2000mg/day citicoline for 4 weeks, administered orally |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleplacebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 16 to 22.
- Call study team for additional screening and information.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Citicoline (cytidine diphosphate-choline)2000mg/day citicoline, administered orally, for 4 weeks | Drug | Citicoline |
| Placebo oral capsuleplacebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally | Drug | Placebo |
Primary outcome
Peripheral Cytokine: IL-1B
Time frame: 4 weeks of treatment
Peripheral cytokine (IL-1B) to measure neuroinflammation.
Peripheral Cytokine: IL-6
Time frame: 4 weeks of treatment
Peripheral cytokine (IL-6) to measure neuroinflammation.
Peripheral Cytokine: TNFα
Time frame: 4 weeks of treatment
Peripheral cytokine (TNFα) to measure neuroinflammation.
Brain Metabolite: N-acetyl-aspartate
Time frame: 4 weeks of treatment
Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
Brain Metabolite: Choline
Time frame: 4 weeks of treatment
Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
Neurocognition: Behavioral impulsivity
Time frame: 4 weeks of treatment
Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
Neurocognition: Cognitive Flexibility and Attention
Time frame: 4 weeks of treatment
Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
Neurocognition: Inhibitory Control and Attention
Time frame: 4 weeks of treatment
Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citicoline (cytidine diphosphate-choline) in people with Alcohol Use Disorder, run by Medical University of South Carolina 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 2 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Peripheral Cytokine: IL-1B (time frame: 4 weeks of treatment). The study lists 8 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 12 Jun 2026.