Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2023-04-30
Study Completion Date
2025-01-31
Brief Summary
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This proposed pilot study aims to assess the effects of N-acetylcysteine (NAC) on alcohol use disorder (AUD). Despite promising preliminary research, no investigations to date have focused on NAC with alcohol use as the primary aim or on individuals specifically seeking treatment for AUD. The present proposal is an 7-week randomized, double-blind, placebo-controlled study of 3000mg of NAC in up to 50 participants (25 NAC, 25 placebo).
The primary aim of the current study is to establish feasibility, dropout rate, and estimate the standard deviation of the outcome measures in order to estimate the required sample for a fully powered clinical trial and to refine the final measures for use in the fully powered clinical trial. Additionally, this study will explore preliminary efficacy signal of NAC.
The primary aim of the current study is to establish feasibility, dropout rate, and estimate the standard deviation of the outcome measures in order to estimate the required sample for a fully powered clinical trial and to refine the final measures for use in the fully powered clinical trial. Additionally, this study will explore preliminary efficacy signal of NAC.
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Detailed Description
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Alcohol abuse is responsible for 1 in 10 deaths among working age adults in the U.S. and costs \~$249 billion annually. Currently approved medications for alcohol use disorder (AUD) exert only small to medium effects on drinking, with estimates indicating 12 to 20 drinkers need to be treated for one of them to benefit from the two leading medications, acamprosate and naltrexone. Thus, many patients do not benefit from current pharmacotherapies for AUD.
N-acetylcysteine (NAC) is one promising pharmacotherapy that is well-tolerated, safe, and exhibits preliminary evidence across a number of psychiatric and neurological disorders. NAC is available over the counter, has been used all over the world for a variety of conditions, most notably for its 1985 FDA approved use as an antidote for acetaminophen overdose.
The NAC dosage was selected as most prior studies in addiction have used 2400-3000mg and even studies up to 3600mg have found it was well-tolerated. Many studies using doses in this range achieved clinically significant improvements, including a study of NAC for smoking cessation which used 3000mg. 7 weeks was selected rather than 12 weeks or longer duration because this within the range of prior clinical trials of NAC (most are 8-12 weeks) and is fitting for the goals of this pilot trial seeking to establish feasibility and sample size for a larger clinical trial. It is beyond the primary aims of this study and the resources of the team to seek longer term outcomes (e.g., drinking at 6 months; https://www.fda.gov/media/91222/download).
N-acetylcysteine (NAC) is one promising pharmacotherapy that is well-tolerated, safe, and exhibits preliminary evidence across a number of psychiatric and neurological disorders. NAC is available over the counter, has been used all over the world for a variety of conditions, most notably for its 1985 FDA approved use as an antidote for acetaminophen overdose.
The NAC dosage was selected as most prior studies in addiction have used 2400-3000mg and even studies up to 3600mg have found it was well-tolerated. Many studies using doses in this range achieved clinically significant improvements, including a study of NAC for smoking cessation which used 3000mg. 7 weeks was selected rather than 12 weeks or longer duration because this within the range of prior clinical trials of NAC (most are 8-12 weeks) and is fitting for the goals of this pilot trial seeking to establish feasibility and sample size for a larger clinical trial. It is beyond the primary aims of this study and the resources of the team to seek longer term outcomes (e.g., drinking at 6 months; https://www.fda.gov/media/91222/download).
Conditions
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Alcohol Use Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Arm 1: n-acetylcysteine. 25 participants randomly selected Arm 2: placebo. 25 participants randomly selected
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Double-blind
Study Groups
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N-acetylcysteine
25 participants randomly selected to receive 1500 milligrams of oral n-acetylcysteine twice daily for 7 weeks.
Group Type
EXPERIMENTAL
N-acetylcysteine
Intervention Type
DRUG
N-acetylcysteine is an FDA approved medication that is used to treat acetaminophen overdose.
Placebo
25 participants randomly selected to receive placebo twice daily for 7 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo
Interventions
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N-acetylcysteine
N-acetylcysteine is an FDA approved medication that is used to treat acetaminophen overdose.
Intervention Type
DRUG
Placebo
Placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Greater than or equal to 18 years of age
2. Meets DSM-V criteria for alcohol use disorder on the SCID-5
3. MHS Healthcare Beneficiary
NOTE. While we are recruiting explicitly from the Addiction Treatment Services (ATS) patient population, we do not require that they are currently receiving treatment at ATS. For participants that are not currently in care we will provide them with resources to pursue psychotherapy while engaged in our study as outlined in the interview treatment questions and physical and mental health resource document.
2. Meets DSM-V criteria for alcohol use disorder on the SCID-5
3. MHS Healthcare Beneficiary
NOTE. While we are recruiting explicitly from the Addiction Treatment Services (ATS) patient population, we do not require that they are currently receiving treatment at ATS. For participants that are not currently in care we will provide them with resources to pursue psychotherapy while engaged in our study as outlined in the interview treatment questions and physical and mental health resource document.
Exclusion Criteria
1. Lifetime clinical diagnosis of schizophrenia or bipolar disorder
2. Currently receiving medication for the treatment of alcohol use disorder including oral or injectable naltrexone (ReVia, Vivitrol), disulfiram (Antabuse), and acamprosate (Campral).
3. Pregnancy
4. Lack of English fluency sufficient to complete study measures.
5. Trying to get pregnant in the next 4 months.
6. Hospitalized because of alcohol use in the past 12 months.
7. History of seizures or delirium tremens.
8. History of liver disease
9. Diagnosis of a neurocognitive disorder (e.g., dementia, alzheimer's, mental retardation).
10. Individuals who were never enrolled into Addiction Treatment Services
2. Currently receiving medication for the treatment of alcohol use disorder including oral or injectable naltrexone (ReVia, Vivitrol), disulfiram (Antabuse), and acamprosate (Campral).
3. Pregnancy
4. Lack of English fluency sufficient to complete study measures.
5. Trying to get pregnant in the next 4 months.
6. Hospitalized because of alcohol use in the past 12 months.
7. History of seizures or delirium tremens.
8. History of liver disease
9. Diagnosis of a neurocognitive disorder (e.g., dementia, alzheimer's, mental retardation).
10. Individuals who were never enrolled into Addiction Treatment Services
Minimum Eligible Age
18 Years
Maximum Eligible Age
74 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Uniformed Services University of the Health Sciences
FED
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
References
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Stahre M, Roeber J, Kanny D, Brewer RD, Zhang X. Contribution of excessive alcohol consumption to deaths and years of potential life lost in the United States. Prev Chronic Dis. 2014 Jun 26;11:E109. doi: 10.5888/pcd11.130293.
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Minarini A, Ferrari S, Galletti M, Giambalvo N, Perrone D, Rioli G, Galeazzi GM. N-acetylcysteine in the treatment of psychiatric disorders: current status and future prospects. Expert Opin Drug Metab Toxicol. 2017 Mar;13(3):279-292. doi: 10.1080/17425255.2017.1251580. Epub 2016 Nov 2.
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Fernandes BS, Dean OM, Dodd S, Malhi GS, Berk M. N-Acetylcysteine in depressive symptoms and functionality: a systematic review and meta-analysis. J Clin Psychiatry. 2016 Apr;77(4):e457-66. doi: 10.4088/JCP.15r09984.
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Burnett EJ, Chandler LJ, Trantham-Davidson H. Glutamatergic plasticity and alcohol dependence-induced alterations in reward, affect and cognition. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Feb 4;65:309-20. doi: 10.1016/j.pnpbp.2015.08.012. Epub 2015 Sep 1.
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Dean O, Giorlando F, Berk M. N-acetylcysteine in psychiatry: current therapeutic evidence and potential mechanisms of action. J Psychiatry Neurosci. 2011 Mar;36(2):78-86. doi: 10.1503/jpn.100057.
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Legastelois R, Botia B, Coune F, Jeanblanc J, Naassila M. Deciphering the relationship between vulnerability to ethanol-induced behavioral sensitization and ethanol consumption in outbred mice. Addict Biol. 2014 Mar;19(2):210-24. doi: 10.1111/adb.12104. Epub 2013 Oct 29.
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Morais-Silva G, Alves GC, Marin MT. N-acetylcysteine treatment blocks the development of ethanol-induced behavioural sensitization and related DeltaFosB alterations. Neuropharmacology. 2016 Nov;110(Pt A):135-142. doi: 10.1016/j.neuropharm.2016.07.009. Epub 2016 Jul 9.
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Reyes RC, Cittolin-Santos GF, Kim JE, Won SJ, Brennan-Minnella AM, Katz M, Glass GA, Swanson RA. Neuronal Glutathione Content and Antioxidant Capacity can be Normalized In Situ by N-acetyl Cysteine Concentrations Attained in Human Cerebrospinal Fluid. Neurotherapeutics. 2016 Jan;13(1):217-25. doi: 10.1007/s13311-015-0404-4.
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Lebourgeois S, Gonzalez-Marin MC, Jeanblanc J, Naassila M, Vilpoux C. Effect of N-acetylcysteine on motivation, seeking and relapse to ethanol self-administration. Addict Biol. 2018 Mar;23(2):643-652. doi: 10.1111/adb.12521. Epub 2017 May 30.
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BACKGROUND
Schneider R Jr, Santos CF, Clarimundo V, Dalmaz C, Elisabetsky E, Gomez R. N-acetylcysteine prevents behavioral and biochemical changes induced by alcohol cessation in rats. Alcohol. 2015 May;49(3):259-63. doi: 10.1016/j.alcohol.2015.01.009. Epub 2015 Feb 13.
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BACKGROUND
Quintanilla ME, Rivera-Meza M, Berrios-Carcamo P, Salinas-Luypaert C, Herrera-Marschitz M, Israel Y. Beyond the "First Hit": Marked Inhibition by N-Acetyl Cysteine of Chronic Ethanol Intake But Not of Early Ethanol Intake. Parallel Effects on Ethanol-Induced Saccharin Motivation. Alcohol Clin Exp Res. 2016 May;40(5):1044-51. doi: 10.1111/acer.13031. Epub 2016 Apr 8.
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BACKGROUND
Schneider R Jr, Bandiera S, Souza DG, Bellaver B, Caletti G, Quincozes-Santos A, Elisabetsky E, Gomez R. N-acetylcysteine Prevents Alcohol Related Neuroinflammation in Rats. Neurochem Res. 2017 Aug;42(8):2135-2141. doi: 10.1007/s11064-017-2218-8. Epub 2017 Mar 16.
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BACKGROUND
Morley KC, Baillie A, Van Den Brink W, Chitty KE, Brady K, Back SE, Seth D, Sutherland G, Leggio L, Haber PS. N-acetyl cysteine in the treatment of alcohol use disorder in patients with liver disease: Rationale for further research. Expert Opin Investig Drugs. 2018 Aug;27(8):667-675. doi: 10.1080/13543784.2018.1501471. Epub 2018 Aug 1.
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BACKGROUND
Squeglia LM, Baker NL, McClure EA, Tomko RL, Adisetiyo V, Gray KM. Alcohol use during a trial of N-acetylcysteine for adolescent marijuana cessation. Addict Behav. 2016 Dec;63:172-7. doi: 10.1016/j.addbeh.2016.08.001. Epub 2016 Aug 4.
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Squeglia LM, Tomko RL, Baker NL, McClure EA, Book GA, Gray KM. The effect of N-acetylcysteine on alcohol use during a cannabis cessation trial. Drug Alcohol Depend. 2018 Apr 1;185:17-22. doi: 10.1016/j.drugalcdep.2017.12.005. Epub 2018 Feb 1.
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Gray KM, Carpenter MJ, Baker NL, DeSantis SM, Kryway E, Hartwell KJ, McRae-Clark AL, Brady KT. A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents. Am J Psychiatry. 2012 Aug;169(8):805-12. doi: 10.1176/appi.ajp.2012.12010055.
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Gray KM, Sonne SC, McClure EA, Ghitza UE, Matthews AG, McRae-Clark AL, Carroll KM, Potter JS, Wiest K, Mooney LJ, Hasson A, Walsh SL, Lofwall MR, Babalonis S, Lindblad RW, Sparenborg S, Wahle A, King JS, Baker NL, Tomko RL, Haynes LF, Vandrey RG, Levin FR. A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults. Drug Alcohol Depend. 2017 Aug 1;177:249-257. doi: 10.1016/j.drugalcdep.2017.04.020. Epub 2017 Jun 10.
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LaRowe SD, Kalivas PW, Nicholas JS, Randall PK, Mardikian PN, Malcolm RJ. A double-blind placebo-controlled trial of N-acetylcysteine in the treatment of cocaine dependence. Am J Addict. 2013 Sep-Oct;22(5):443-52. doi: 10.1111/j.1521-0391.2013.12034.x. Epub 2013 May 15.
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Costa DLC, Diniz JB, Requena G, Joaquim MA, Pittenger C, Bloch MH, Miguel EC, Shavitt RG. Randomized, Double-Blind, Placebo-Controlled Trial of N-Acetylcysteine Augmentation for Treatment-Resistant Obsessive-Compulsive Disorder. J Clin Psychiatry. 2017 Jul;78(7):e766-e773. doi: 10.4088/JCP.16m11101.
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Sinha R, Fox HC, Hong KI, Hansen J, Tuit K, Kreek MJ. Effects of adrenal sensitivity, stress- and cue-induced craving, and anxiety on subsequent alcohol relapse and treatment outcomes. Arch Gen Psychiatry. 2011 Sep;68(9):942-52. doi: 10.1001/archgenpsychiatry.2011.49. Epub 2011 May 2.
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Schulte MHJ, Wiers RW, Boendermaker WJ, Goudriaan AE, van den Brink W, van Deursen DS, Friese M, Brede E, Waters AJ. The effect of N-acetylcysteine and working memory training on cocaine use, craving and inhibition in regular cocaine users: correspondence of lab assessments and Ecological Momentary Assessment. Addict Behav. 2018 Apr;79:24-31. doi: 10.1016/j.addbeh.2017.11.044. Epub 2017 Dec 11.
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Levi Bolin B, Alcorn JL 3rd, Lile JA, Rush CR, Rayapati AO, Hays LR, Stoops WW. N-Acetylcysteine reduces cocaine-cue attentional bias and differentially alters cocaine self-administration based on dosing order. Drug Alcohol Depend. 2017 Sep 1;178:452-460. doi: 10.1016/j.drugalcdep.2017.05.039. Epub 2017 Jun 29.
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Breier A, Liffick E, Hummer TA, Vohs JL, Yang Z, Mehdiyoun NF, Visco AC, Metzler E, Zhang Y, Francis MM. Effects of 12-month, double-blind N-acetyl cysteine on symptoms, cognition and brain morphology in early phase schizophrenia spectrum disorders. Schizophr Res. 2018 Sep;199:395-402. doi: 10.1016/j.schres.2018.03.012. Epub 2018 Mar 24.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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0000
Identifier Type: -
Identifier Source: org_study_id
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