CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
SXC-2023 +1 moredrug
Likely dose
SXC-2023 oral capsules (dose not specified in published record)AI-extracted
Key inclusion· 7
  • ✓Age 28–55 years inclusive at screening
  • ✓Non-treatment-seeking smokers regularly using tobacco with FTND score ≥4 and ≥10 cigarettes/day at screening
  • ✓Smoked for >5 years at screening
  • ✓Meets DSM-5 criteria for tobacco use disorder
Key exclusion· 11
  • ✕Pregnant or breastfeeding
  • ✕Positive for active hepatitis, HIV, coagulopathy, or hepatic illness
  • ✕DSM-5 criteria for alcohol/substance use disorder (except tobacco use disorder)
  • ✕History of clinically significant psychiatric condition (except tobacco use disorder) or disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03887429
NCT03887429Phase 2Completed
CompareCT.gov

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

Promentis Pharmaceuticals, Inc.·interventional·Posted Mar 25, 2019·Updated Jul 17, 2020

In Brief

A Phase 2 clinical trial evaluating SXC-2023 and Placebos for Impulse Control Disorders. Completed, enrolled 34 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImpulse Control Disorders
CountriesUnited States
CollaboratorsCelerion, Baylor College of Medicine

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartMar 4, 2019
Primary CompletionJul 2, 2019
Study CompletionJul 9, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.3 years ago

Interventions

SXC-2023drug

SXC-2023 oral capsules

Placebosdrug

Matching Placebo oral capsules