NCT04405193 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ballester J, Valentine G, Sofuoglu M
Pharmacological treatments for methamphetamine addiction: current status and future directions. Expert Rev Clin Pharmacol. 2017 Mar;10(3):305-314. doi: 10.1080/17512433.2017.1268916. Epub 2016 Dec 20. Review.
Grant JE, Odlaug BL, Kim SW
A double-blind, placebo-controlled study of N-acetyl cysteine plus naltrexone for methamphetamine dependence. Eur Neuropsychopharmacol. 2010 Nov;20(11):823-8. doi: 10.1016/j.euroneuro.2010.06.018. Epub 2010 Jul 22.
Ling W, Mooney L, Haglund M
Treating methamphetamine abuse disorders. Curr Psychiatry. 2014; 13(9): 37 - 44.
McKetin R, Dean OM, Baker AL, Carter G, Turner A, Kelly PJ, Berk M
A potential role for N-acetylcysteine in the management of methamphetamine dependence. Drug Alcohol Rev. 2017 Mar;36(2):153-159. doi: 10.1111/dar.12414. Epub 2016 May 30.
Mousavi SG, Sharbafchi MR, Salehi M, Peykanpour M, Karimian Sichani N, Maracy M
The efficacy of N-acetylcysteine in the treatment of methamphetamine dependence: a double-blind controlled, crossover study. Arch Iran Med. 2015 Jan;18(1):28-33. doi: 0151801/AIM.008.
Nocito Echevarria MA, Andrade Reis T, Ruffo Capatti G, Siciliano Soares V, da Silveira DX, Fidalgo TM
N-acetylcysteine for treating cocaine addiction - A systematic review. Psychiatry Res. 2017 May;251:197-203. doi: 10.1016/j.psychres.2017.02.024. Epub 2017 Feb 11. Review.
Prakash MD, Tangalakis K, Antonipillai J, Stojanovska L, Nurgali K, Apostolopoulos V
Methamphetamine: Effects on the brain, gut and immune system. Pharmacol Res. 2017 Jun;120:60-67. doi: 10.1016/j.phrs.2017.03.009. Epub 2017 Mar 14. Review.
Winslow BT, Voorhees KI, Pehl KA
Methamphetamine abuse. Am Fam Physician. 2007 Oct 15;76(8):1169-74. Review.

The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms

Details for clinical trial NCT04405193

Clinical trial NCT04405193 - References