NCT04659278 - 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)

Everitt BJ, Robbins TW
Neural systems of reinforcement for drug addiction: from actions to habits to compulsion. Nat Neurosci. 2005 Nov;8(11):1481-9. Review. Erratum in: Nat Neurosci. 2006 Jul;9(7):979.
Grotenhermen F
Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. Review.
Laviolette SR, Grace AA
The roles of cannabinoid and dopamine receptor systems in neural emotional learning circuits: implications for schizophrenia and addiction. Cell Mol Life Sci. 2006 Jul;63(14):1597-613. Review.
MacCallum CA, Russo EB
Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4. Review.
Moreira FA, Lutz B
The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16. Review.
Parsons LH, Hurd YL
Endocannabinoid signalling in reward and addiction. Nat Rev Neurosci. 2015 Oct;16(10):579-94. doi: 10.1038/nrn4004. Epub 2015 Sep 16. Review.

A Post Marketing Study to Evaluate the Safety and Efficacy of Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use

Details for clinical trial NCT04659278

Clinical trial NCT04659278 - References