Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
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.
Timeline
- Start
- 2019-03-04
- Primary completion
- 2019-07-02
- Completion
- 2019-07-09
Outcome
Mixed primary results
registry MEAN SXC-2023 800mg: -1.757 (Standard Deviation 6.8491) milliseconds NCT03887429 ↗
registry MEAN Placebo: 3.956 (Standard Deviation 3.9661) milliseconds NCT03887429 ↗
registry analysis (superiority test); SXC-2023 800mg vs Placebo; p =.009; t-test, 1 sided NCT03887429 ↗
registry MEAN SXC-2023 200mg: .03236 (Standard Deviation .02652) units on a scale NCT03887429 ↗
registry MEAN Placebo: .03931 (Standard Deviation .01569) units on a scale NCT03887429 ↗
registry analysis (superiority test); Placebo; p =.015; t-test, 1 sided NCT03887429 ↗
registry analysis (superiority test); SXC-2023 800mg; p >.1; t-test, 1 sided NCT03887429 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SXC-2023 | Unknown | 200 mg | Oral |
| Subject | SXC-2023 | Unknown | 800 mg | Oral |