Trial Of NS2359 For The Treatment of Cocaine Dependence
Status:
Completed
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
NS2359 attenuates the euphoria associated with cocaine use. In a manner parallel to cocaine,
NS2359 blocks the reuptake of dopamine (DA), norepinephrine (NE), and serotonin (5HT) with
nanomolar affinities at the 3 transporters. In primates NS2359 significantly attenuated
cocaine self-administration. In several phase II clinical trials for major depressive
disorder and adult attention deficit disorder, NS2359 did not cause euphoria. NS2359
exhibited no abuse potential in a human laboratory study comparing NS2359 with amphetamine.
In a phase I human laboratory interaction study, NS2359 showed no toxicity after 20 or 40 mg
of cocaine, but it attenuated the both the rewarding and cardiovascular effects of
intravenous cocaine. On the basis of these promising studies, investigators propose a Phase
II double-blind clinical trial of NS2359 in cocaine addiction (CA). The proposed trial will
involve 100 CA subjects participating in an eight week trial, including a 1-week baseline and
8 weeks of NS2359 or placebo treatment. Four weeks after completing the medication phase,
there will be one follow-up visit. Subjects will be randomly assigned to treatment with
placebo or 2 mg NS2359 daily, with a possible decrease to 1 mg daily for adverse events. This
dose range is selected on the basis of phase I and II evidence of tolerability and NS2359
plasma levels which were associated with blockade of cocaine reward. This project has the
potential to identify the first effective pharmacotherapy for CA.