Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal

Impulse Control Disorders Clinical Trial

Official title: An Exploratory, Placebo-Controlled, Crossover Study to Examine the Safety and Activity of SXC-2023 to Improve Behavioral Dynamics in Non-Treatment Seeking Adults Undergoing Acute Nicotine Withdrawal

Status Completed

Clinical Trial Summary

The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 or placebo when dosed for 5 days in adults with tobacco use disorder who voluntarily abstain from the use of cigarettes.

Clinical Trial Description

This study is a Phase 2A, randomized, double-blinded, placebo-controlled, two-period crossover study to evaluate the effect of two doses of SXC-2023 on measures of impulsivity and inhibitory control, urge for cigarettes, and mood in non-treatment seeking smokers who are abstaining from smoking. The study consists of a screening period of up to 30 days, a 5 day randomized double-blind treatment period, a 9 day washout period, followed by a second 5 day randomized double-blind treatment period, with a safety follow-up period 7 days after the last dose of study medication. ;

Related Conditions & MeSH terms

• Impulse Control Disorders

• NCT number: NCT03887429
• Study type: Interventional
• Source: Promentis Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: March 4, 2019
• Completion date: July 9, 2019