NCT03887429

Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Promentis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Impulse Control Disorders

Interventions

Type	Name	Description
DRUG	SXC-2023	SXC-2023 oral capsules
DRUG	Placebos	Matching Placebo oral capsules

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-07-02
• Completion: 2019-07-09
• First posted: 2019-03-25
• Last updated: 2020-07-17
• Results posted: 2020-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study