Citicoline in Youth Alcohol Use Disorder

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05870111

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Citicoline (cytidine diphosphate-choline) Drug: Placebo oral capsule	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2028

Anticipated Study Completion Date :

Aug 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citicoline 2000mg/day citicoline for 4 weeks, administered orally	Drug: Citicoline (cytidine diphosphate-choline) 2000mg/day citicoline, administered orally, for 4 weeks
Placebo Comparator: Placebo placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally	Drug: Placebo oral capsule placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally

Arm

Intervention/Treatment

Experimental: Citicoline

2000mg/day citicoline for 4 weeks, administered orally

Drug: Citicoline (cytidine diphosphate-choline)

2000mg/day citicoline, administered orally, for 4 weeks

Placebo Comparator: Placebo

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

Drug: Placebo oral capsule

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

Outcome Measures

Primary Outcome Measures

Peripheral Cytokine: IL-1B [4 weeks of treatment]
Peripheral cytokine (IL-1B) to measure neuroinflammation.
Peripheral Cytokine: IL-6 [4 weeks of treatment]
Peripheral cytokine (IL-6) to measure neuroinflammation.
Peripheral Cytokine: TNFα [4 weeks of treatment]
Peripheral cytokine (TNFα) to measure neuroinflammation.
Brain Metabolite: N-acetyl-aspartate [4 weeks of treatment]
Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
Brain Metabolite: Choline [4 weeks of treatment]
Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
Neurocognition: Behavioral impulsivity [4 weeks of treatment]
Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
Neurocognition: Cognitive Flexibility and Attention [4 weeks of treatment]
Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
Neurocognition: Inhibitory Control and Attention [4 weeks of treatment]
Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion:

Age 16 to 22.

Call study team for additional screening and information.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lindsay Squeglia, Associate Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05870111

Other Study ID Numbers:

Pro00128800

First Posted:

May 23, 2023

Last Update Posted:

May 23, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lindsay Squeglia, Associate Professor, Medical University of South Carolina

Citicoline

Additional relevant MeSH terms:

Alcoholism

Alcohol Drinking

Choline

Cytidine Diphosphate Choline

Study Results

No Results Posted as of May 23, 2023