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N-Acetylcysteine for Bipolar and Alcohol Use Disorders

27. oktober 2026 opdateret af: James Prisciandaro, Medical University of South Carolina

N-acetylcysteine for Restoring Glutamate/Glutathione Homeostasis and Reducing Heavy Drinking in Co-occurring Bipolar and Alcohol Use Disorders

This study will evaluate N-acetylcysteine (NAC) in adults with bipolar disorder and alcohol use disorder. Participants will be randomly assigned to receive NAC or matched placebo for 28 days. The study includes five visits and three MRI brain imaging scans. Questionnaires, clinical interviews, alcohol and drug assessments, laboratory testing, and monitoring for possible side effects will be completed during study visits.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This randomized, placebo-controlled, double-blind, parallel-group mechanistic clinical trial will evaluate adjunctive N-acetylcysteine (NAC) in adults with co-occurring bipolar disorder and alcohol use disorder. The study is designed to examine whether NAC changes dorsal anterior cingulate cortex glutamate and glutathione homeostasis and brain activation to alcohol cues, and whether those changes are associated with reductions in heavy drinking and depressive symptoms. Participants will complete a baseline evaluation, a pretreatment MRI visit, MRI visits at 14 and 28 days after treatment begins, and a safety visit within 72 hours after the day 28 visit. Study procedures include clinical interviews, self-report questionnaires, alcohol and drug assessments, blood and urine collection, and proton magnetic resonance spectroscopy and functional MRI. Treatment assignment details, intervention records, and outcome-measure records are intentionally left for study-team completion.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Sara Hix
  • Telefonnummer: 843-792-0572
  • E-mail: hixs@musc.edu

Studiesteder

  • Forenede Stater
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
        • Kontakt:
          • Sara Hix

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 18 to 60 years.
  2. Meet DSM-5 criteria for bipolar I or bipolar II disorder.
  3. Prescribed daily use of at least one FDA-approved mood-stabilizing medication (lithium, divalproex sodium, lamotrigine, or a second-generation antipsychotic).
  4. Meet DSM-5 criteria for current, within the past 90 days, moderate to severe alcohol use disorder.
  5. Active alcohol use in the past 14 days, with heavy drinking days on at least 50% of drinking days in the past 30 days.
  6. Able to provide informed consent and read, understand, and accurately complete assessment instruments.
  7. Willing to commit to medication treatment and follow-up assessments.
  8. Willing to abstain from antioxidant supplements for the duration of the study.

Exclusion Criteria:

  1. Primary psychiatric diagnosis other than bipolar disorder.
  2. Uncontrolled neurological condition that could confound study results.
  3. History of brain injury with loss of consciousness greater than 5 minutes.
  4. History of intellectual disability or dementia.
  5. Uncontrolled medical condition that may adversely affect study conduct or participant safety.
  6. Hepatocellular disease as defined in the protocol.
  7. Renal insufficiency as defined in the protocol.
  8. Concomitant use of nitroglycerin, carbamazepine, or another medication deemed hazardous with NAC.
  9. Concomitant use of specified alcohol-use-disorder medications or medications that could interfere with glutamate transmission.
  10. Electroconvulsive therapy in the past 3 months.
  11. Medication dose change of 20% or greater within 2 weeks before testing.
  12. Pregnancy, lactation, or refusal to use adequate contraception when applicable.
  13. Current suicidal or homicidal risk.
  14. Baseline MADRS score greater than 35 or YMRS score greater than 25.
  15. Clinically significant alcohol withdrawal symptoms or autonomic instability.
  16. NAC use in the last month or prior adverse effects from NAC.
  17. Has an allergy to riboflavin
  18. Significant claustrophobia or prior negative experience with MRI.
  19. Non-MRI-safe material in the body.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A - N-Acetylcysteine

After group assignment but before taking any study medication, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive N-Acetylcysteine (NAC) 2 times a day for a total of 28 days. They will have follow up MRIs on day 14 and 28.
Medicin: N-acetyl cysteine

28 days of NAC taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28
Placebo komparator: Group B - Placebo

After group assignment but before taking any study medication, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group B will receive Placebo 2 times a day for a total of 28 days. They will have follow up MRIs on day 14 and 28.
Medicin: Placebo

28 days of Placebo taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in dACC glutamate/glutathione levels through Proton Magnetic Resonance
Tidsramme: Baseline to end of treatment, approximately 28 days

Concentrations of glutamate and glutathione in the dorsal anterior cingulate cortex will be measured on day 1, 14, and 28.
Baseline to end of treatment, approximately 28 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of South Carolina

Samarbejdspartnere

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Efterforskere

  • Ledende efterforsker: James J. Prisciandaro, Ph.D., Medical University of South Carolina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

31. august 2031

Studieafslutning (Anslået)

31. august 2031

Datoer for studieregistrering

Først indsendt

27. oktober 2026

Først indsendt, der opfyldte QC-kriterier

27. oktober 2026

Først opslået (Faktiske)

3. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00153022

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

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Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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