Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder

Summary

This is a double blind, placebo controlled, randomized trial to evaluate the safety and preliminary efficacy of ANS-6637 in adults with opioid use disorder with and without opioid agonist therapy. Patients will be randomized to two arms: (1) ANS-6637 for three months vs (2) Placebo for three months. Subjects will subsequently be followed for an additional one month post treatment.

Timeline

Start

2021-01

Primary completion

2021-01-12

Completion

2021-01-12

Outcome

Outcome not reported

Stopped: “The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences, the product company of ANS-6637, is no longer pursuing research with this compound.”

Drugs

Indications