THE PHASE II PROOF OF CONCEPT (COMB) STUDY PROTOCOL PUBLISHED

The phase II Proof of Concept (COMB study protocol has been published at PLOS ONE, an inclusive journal community for research in science and medicine. This is an important step in the development of a new pharmaceutical treatment option for the many individuals around the world suffering from Alcohol Use Disorder (AUD).

The COMB Phase 2 study, finalized during summer 2023, is a randomized, double-blind, placebo controlled, multicentre trial on the efficacy of varenicline and bupropion, two medicines affecting dopamine, in combination and alone for treatment of alcohol use disorder (AUD).

The study results support the dopamine deficiency hypothesis of AUD and suggest that varenicline in combination with bupropion may considerably reduce alcohol intake with the potential to reduce the risk to die from alcohol related causes.

AUD is number four on the Global Burden of Disease list, afflicting 100 million people, causing 3 million deaths per year, and generating enormous costs.

The authors of the study protocol are Professor Bo Söderpalm, Senior Researcher Andrea de Bejczy at the Addiction Biology Unit, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden and Clinical Study Coordinator Helga Lidö.

Link to the published study protocol at PLOS ONE: A randomized, double-blind, placebo-controlled, multicentre trial on the efficacy of varenicline and bupropion in combination and alone for treatment of alcohol use disorder: Protocol for the COMB study | PLOS ONE