Citicoline for Alcoholism

Overseen By Cori Herring, BS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how citicoline, an over-the-counter supplement, affects the immune system, brain function, and thinking skills in adolescents who might use alcohol. Researchers will compare citicoline to a placebo, a pill that looks the same but contains no active ingredients, to determine any differences in effects. The trial will last four weeks, with participants taking either citicoline or the placebo daily. It suits individuals aged 16 to 22 who may occasionally use alcohol and are interested in how supplements could impact their health. As a Phase 2 trial, this research measures citicoline's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please contact the study team for more details.

Is there any evidence suggesting that citicoline is likely to be safe for humans?

Research shows that citicoline, an over-the-counter supplement, is generally safe and easy for most people to take. Studies on its use for addiction issues, such as cocaine addiction, indicate that people usually tolerate it well. In these studies, citicoline did not cause any major problems or side effects.

Another study tested citicoline to see if it could help reduce alcohol consumption. The results suggested that while it was safe to use, it didn't significantly lower alcohol intake. This means people didn't experience harmful effects from taking it.

Overall, evidence suggests that citicoline is safe for use. For any concerns or questions, consulting a healthcare professional before joining a trial is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Unlike the standard treatments for alcoholism, which often include medications like naltrexone or acamprosate, citicoline is unique because it targets the brain's neurotransmitter pathways. Citicoline is a naturally occurring compound that supports brain health by boosting phospholipid production, which may help improve cognitive function and reduce cravings associated with alcohol use. Researchers are excited about citicoline because it offers a novel mechanism of action that could complement existing therapies, potentially enhancing treatment outcomes for individuals struggling with alcoholism.

What evidence suggests that citicoline might be an effective treatment for alcoholism?

This trial will compare citicoline with a placebo to evaluate its effectiveness in treating alcohol use disorder. Research has shown that citicoline, an over-the-counter supplement, has been studied for various uses but hasn't effectively reduced alcohol use. Studies have found that while citicoline is generally safe and well tolerated, it doesn't significantly lower alcohol consumption or improve related outcomes. Although citicoline may help with some cognitive issues, these benefits don't appear to apply to alcohol use disorder. Despite its safety, current research provides no strong evidence that citicoline helps with alcohol-related problems. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for young people aged 16 to 22 who may use alcohol. Participants will need additional screening by the study team to confirm eligibility.

Inclusion Criteria

I am between 16 and 22 years old.

Call study team for additional screening and information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 2000mg/day citicoline or a placebo for 4 weeks to evaluate effects on immune system, brain, and cognition

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Citicoline

Trial Overview The study is testing citicoline, a dietary supplement, against a placebo (an inactive pill) to see its effects on the immune system, brain function, and thinking abilities in adolescents with alcohol use.

How Is the Trial Designed?

Group I: Citicoline Experimental Treatment 1 Intervention

2000mg/day citicoline for 4 weeks, administered orally

Group II: Placebo Placebo Group 1 Intervention

placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally

Citicoline is already approved in Japan, United States, China, India for the following indications:

Approved in Japan as Citicoline for:

• Stroke
• Head trauma

Approved in United States as Citicoline for:

• Dietary supplement for cognitive support

Approved in China as Citicoline for:

• Stroke
• Head trauma

Approved in India as Citicoline for:

• Stroke
• Head trauma
• Cognitive disorders

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study involving 12 healthy adult volunteers, CDP-choline (citicoline) was administered in two different doses (600 mg and 1 g per day) over 5 days, showing that it is generally well-tolerated with minimal side effects.

The only reported adverse effects were transient headaches in a few participants, indicating that CDP-choline has a favorable safety profile compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDP-choline: repeated oral dose tolerance studies in adult healthy volunteers. Dinsdale, JR., Griffiths, GK., Castelló, J., et al.[2013]

A systematic review of 11 clinical studies involving 2771 patients found that citicoline significantly increases the rate of independence in individuals with traumatic brain injury (TBI), with a relative risk of 1.18.

The analysis showed no significant effects on mortality or safety concerns related to citicoline, suggesting it is a safe treatment option for TBI when administered in the acute phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citicoline for the Management of Patients with Traumatic Brain Injury in the Acute Phase: A Systematic Review and Meta-Analysis. Secades, JJ., Trimmel, H., Salazar, B., et al.[2023]

Citicoline shows potential clinical benefits for elderly patients with cognitive deficits and early-stage Alzheimer's disease, acting as a choline donor that supports the production of acetylcholine and neuronal membrane components.

Research indicates that citicoline has cholinergic and neuroprotective effects, which may help improve neuronal membrane integrity and functionality, although its efficacy in stroke patients remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic applications of citicoline for stroke and cognitive dysfunction in the elderly: a review of the literature. Conant, R., Schauss, AG.[2013]

CDP-choline, when injected into the paw of rats, effectively reduces pain sensitivity and inflammation in a dose-dependent manner, demonstrating its potential as a treatment for acute pain.

The antihypersensitivity and antiinflammatory effects of CDP-choline are mediated through alpha7 nicotinic acetylcholine receptors, as shown by the complete blockage of its effects when an antagonist is used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of peripherally administered CDP-choline in an acute inflammatory pain model: the role of alpha7 nicotinic acetylcholine receptor. Gurun, MS., Parker, R., Eisenach, JC., et al.[2013]

The study investigated the distribution of 14C-Methyl labelled CDP-choline (citicoline) in the brains of rats after oral administration, with assessments made at 5 hours and 24 hours post-dose.

Results showed both extra- and intracellular distribution of the drug, indicating its potential for effective brain uptake and suggesting a mechanism for its action in neurological applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-resolution autoradiography in rat brain after administering labelled CDP-choline. Romero, A., Serratosa, J., Sacristán, A., et al.[2013]

CDP-choline (citicoline) shows some evidence of improving memory and behavior in elderly patients with chronic cerebral disorders, based on a review of 14 studies with varying durations and participant characteristics.

The drug was well tolerated, but there was no significant evidence of benefit on attention, highlighting the need for further long-term studies focusing on specific conditions like Vascular Mild Cognitive Impairment or vascular dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytidinediphosphocholine (CDP-choline) for cognitive and behavioural disturbances associated with chronic cerebral disorders in the elderly. Fioravanti, M., Yanagi, M.[2020]

CDP-choline is a safe and effective treatment that enhances recovery in patients with head trauma and acute ischemic cerebral vascular disease, improving cognitive function and reducing hospital stays.

It also shows promise in treating cognitive impairments associated with aging and degenerative diseases like Alzheimer's, as it improves cognitive scores and slows disease progression without serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDP-choline: pharmacological and clinical review. Secades, JJ., Frontera, G.[2013]

Citicoline, a substance that helps produce important brain lipids, has shown neuroprotective effects in preclinical studies, but recent large clinical trials found no benefits for treating ischaemic stroke or traumatic brain injury.

Despite its limited efficacy in acute conditions, citicoline may still be beneficial for slowly progressing neurodegenerative disorders like glaucoma and mild vascular cognitive impairment, although the exact mechanisms of its action remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective properties of citicoline: facts, doubts and unresolved issues. Grieb, P.[2021]

Citicoline is a safe and effective treatment that enhances brain metabolism and neuroprotection, particularly in conditions like cerebral vascular disease and head trauma, with studies showing improved recovery outcomes and cognitive function in patients.

It has been demonstrated to increase neurotransmitter levels, support neuronal membrane health, and has no significant side effects, making it suitable for various cognitive disorders, including Alzheimer's disease and Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citicoline: pharmacological and clinical review, 2006 update. Secades, JJ., Lorenzo, JL.[2013]

The study assessed the acute toxicity of a single dose of CDP-choline (citicoline) in mice and rats, determining the lethal dose (LD50) values to understand its safety profile.

Different administration routes were evaluated, providing insights into how the method of delivery may affect the toxicity of CDP-choline, which is important for its therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDP-choline: acute toxicity study. Grau, T., Romero, A., Sacristán, A., et al.[2013]

Mice treated with CDP-choline showed a significantly higher tolerance to nicotine toxicity compared to those treated with agar, indicating a protective effect of CDP-choline against nicotine's harmful effects.

The study suggests that CDP-choline may enhance the safety profile of nicotine administration, as evidenced by the observed difference in lethal dose (LD50) between the two groups of mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the protection of CDP-choline against nicotine intoxication. Grau, T., Romero, A., Sacristán, A., et al.[2015]

In a study involving 2817 patients, primarily aged 60 to 80, oral CDP-choline (citicoline) significantly improved symptoms of dizziness (48.4% improvement), headaches (46.5%), and insomnia (38.6%) over treatment periods of 15 days to 2 months.

The safety profile of CDP-choline was excellent, with only 5.01% of patients experiencing side effects, mainly mild digestive issues in 3.6% of cases, indicating it is a well-tolerated treatment option for neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral CDP-choline. Drug surveillance study in 2817 cases. Lozano Fernández, R.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6370505/

A Randomized, Double-Blind, Placebo-Controlled Trial of ... The favorable effects reported with citicoline for cocaine use, cognitive disorders, and other conditions do not appear to extend to alcohol use disorder.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30457668/

A Randomized, Double-Blind, Placebo-Controlled Trial of ... Conclusions: This proof-of-concept study observed that citicoline was well tolerated, but was not associated with a reduction in alcohol use or other outcomes, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05870111

NCT05870111 | Citicoline in Youth Alcohol Use Disorder Study Overview. 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 ...

4. utsouthwestern.elsevierpure.com utsouthwestern.elsevierpure.com/en/publications/a-randomized-double-blind-placebo-controlled-trial-of-citicoline--3

A Randomized, Double-Blind, Placebo-Controlled Trial of ... Conclusions: This proof-of-concept study observed that citicoline was well tolerated, but was not associated with a reduction in alcohol use or other outcomes, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/acer.13928

A Randomized, Double‐Blind, Placebo‐Controlled Trial of ... This proof-of-concept study observed that citicoline was well tolerated, but was not associated with a reduction in alcohol use or other outcomes, as compared ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK252979/

Citicoline in addictive disorders: a review of the literature - NCBI RESULTS: Most addiction research investigated citicoline for cocaine use. The findings suggest that it is safe and well tolerated. Furthermore, citicoline ...

7. utsouthwestern.elsevierpure.com utsouthwestern.elsevierpure.com/en/publications/citicoline-in-addictive-disorders-a-review-of-the-literature

Citicoline in addictive disorders: A review of the literature Results: Most addiction research investigated citicoline for cocaine use. The findings suggest that it is safe and well tolerated. Furthermore, citicoline ...