Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal

NCT03887429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-07-17

Study results available
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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.

Conditions

  • Impulse Control Disorders

Interventions

DRUG

SXC-2023

SXC-2023 oral capsules

DRUG

Placebos

Matching Placebo oral capsules

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY
  • Baylor College of Medicine

    collaborator OTHER
  • Promentis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2019-07-02
Completion
2019-07-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887429 on ClinicalTrials.gov