N-Acetylcysteine for Bipolar and Alcohol Use Disorders
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Sara Hix
- Telefonnummer: 843-792-0572
- E-post: hixs@musc.edu
Studiesteder
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Ta kontakt med:
- Sara Hix
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 18 to 60 years.
- Meet DSM-5 criteria for bipolar I or bipolar II disorder.
- Prescribed daily use of at least one FDA-approved mood-stabilizing medication (lithium, divalproex sodium, lamotrigine, or a second-generation antipsychotic).
- Meet DSM-5 criteria for current, within the past 90 days, moderate to severe alcohol use disorder.
- Active alcohol use in the past 14 days, with heavy drinking days on at least 50% of drinking days in the past 30 days.
- Able to provide informed consent and read, understand, and accurately complete assessment instruments.
- Willing to commit to medication treatment and follow-up assessments.
- Willing to abstain from antioxidant supplements for the duration of the study.
Exclusion Criteria:
- Primary psychiatric diagnosis other than bipolar disorder.
- Uncontrolled neurological condition that could confound study results.
- History of brain injury with loss of consciousness greater than 5 minutes.
- History of intellectual disability or dementia.
- Uncontrolled medical condition that may adversely affect study conduct or participant safety.
- Hepatocellular disease as defined in the protocol.
- Renal insufficiency as defined in the protocol.
- Concomitant use of nitroglycerin, carbamazepine, or another medication deemed hazardous with NAC.
- Concomitant use of specified alcohol-use-disorder medications or medications that could interfere with glutamate transmission.
- Electroconvulsive therapy in the past 3 months.
- Medication dose change of 20% or greater within 2 weeks before testing.
- Pregnancy, lactation, or refusal to use adequate contraception when applicable.
- Current suicidal or homicidal risk.
- Baseline MADRS score greater than 35 or YMRS score greater than 25.
- Clinically significant alcohol withdrawal symptoms or autonomic instability.
- NAC use in the last month or prior adverse effects from NAC.
- Has an allergy to riboflavin
- Significant claustrophobia or prior negative experience with MRI.
- Non-MRI-safe material in the body.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
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. |
28 days of Placebo taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in dACC glutamate/glutathione levels through Proton Magnetic Resonance
Tidsramme: Baseline to end of treatment, approximately 28 days
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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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: James J. Prisciandaro, Ph.D., Medical University of South Carolina
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Bipolare og relaterte lidelser
- Psykiske lidelser
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Alkoholrelaterte lidelser
- Stemningsforstyrrelser
- Alkoholisme
- Bipolar lidelse
- Aminosyrer, peptider og proteiner
- Svovelforbindelser
- Organiske kjemikalier
- Aminosyrer
- Cystein
- Aminosyrer, svovel
- Acetylcystein
Andre studie-ID-numre
- Pro00153022
Plan for individuelle deltakerdata (IPD)
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