NCT02798627

A Phase II, Double-Blind, Placebo-Controlled, Trial Of NS2359 For The Treatment of Cocaine Dependence

Completed Phase 2 Results posted Last updated 19 May 2021

What this trial tests

Phase 2 trial testing NS2359 in Cocaine Use Disorder in 55 participants. Completed in 1 October 2020.

Timeline

1 May 2016

Primary endpoint
1 March 2020

1 October 2020

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	55
Start date	1 May 2016
Primary completion	1 March 2020
Estimated completion	1 October 2020
Sites	1 location across United States

Drugs / interventions tested

• NS2359 — full drug profile →
• placebo

Conditions studied

• Cocaine Use Disorder — all drugs for Cocaine Use Disorder →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with Cocaine Use Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Number of Participants Who Achieved Abstinence From Cocaine During the Last Three Weeks of the Trial
  Time frame: 8 weeks
  Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the NS2359 Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial \[ Time Frame: weeks 6,7.8 of the trial \] Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.