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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Sara Hix
- Telefoonnummer: 843-792-0572
- E-mail: hixs@musc.edu
Studie Locaties
-
-
South Carolina
-
Charleston, South Carolina, Verenigde Staten, 29425
- Medical University of South Carolina
-
Contact:
- Sara Hix
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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-vergelijker: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in dACC glutamate/glutathione levels through Proton Magnetic Resonance
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: James J. Prisciandaro, Ph.D., Medical University of South Carolina
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Bipolaire en aanverwante stoornissen
- Psychische aandoening
- Middelgerelateerde aandoeningen
- Chemisch veroorzaakte aandoeningen
- Aan alcohol gerelateerde aandoeningen
- Stemmingsstoornissen
- Alcoholisme
- Bipolaire stoornis
- Aminozuren, peptiden en eiwitten
- Zwavelverbindingen
- Organische chemicaliën
- Aminozuren
- Cysteïne
- Aminozuren, zwavel
- Acetylcysteïne
Andere studie-ID-nummers
- Pro00153022
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .