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NCT02723162 · ClinicalTrials.gov registry record · Phase 2
Translational Neuropsychopharmacology Research of Nicotine Addiction
A Phase 2 study of Nicotine Dependence, Cigarettes, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT02723162: Completed Phase 2 study of Nicotine Dependence, Cigarettes, sponsored by Medical University of South Carolina.
NCT02723162 is a Phase 2 study of Nicotine Dependence, Cigarettes that has completed, run by Medical University of South Carolina. The registered enrollment target is 67 participants, below the 223-participant average among 3 other Nicotine Dependence, Cigarettes trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02723162, a Phase 2 study of Nicotine Dependence, Cigarettes, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC) on neural circuitry function and treating nicotine addiction. Healthy adult nicotine dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO. Following 1 week of medication, participants will be contingently reinforced for 3 days of smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI) techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task. Participants will be followed over the next 3 weeks of treatment and clinical variables will be assessed.
Primary Outcome
Measure the Effects of Varenicline and N-Acetylcysteine (NAC) on brain activation to smoking images while participants undergo Functional Magnetic Resonance (fMRI) Imaging. Mean percent signal change of fMRI BOLD in the insula and nucleus accumbens will be recorded during smoking images. The lower the BOLD signal response, the better the outcome, meaning reduced reactivity to smoking images.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG N-Acetylcysteine (NAC)
- DRUG Varenicline (VRN)
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2016-05-04 |
| Est. Completion | 2020-03-09 |
| Phase | Phase 2 |
What the finished NCT02723162 record still lists
NCT02723162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 223-participant average among 3 other Nicotine Dependence, Cigarettes trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Nicotine Dependence, Cigarettes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02723162 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT02723162 about?
NCT02723162 is a clinical study titled "Translational Neuropsychopharmacology Research of Nicotine Addiction". This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC) on neural circuitry function and treating nicotine addiction. Healthy adult nicotine dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four PBO-controlled conditions fo...
What is the current status of trial NCT02723162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2016-05-04. Estimated completion is 2020-03-09.
What conditions does trial NCT02723162 study?
This clinical trial studies the following conditions: Nicotine Dependence, Cigarettes.
What interventions are being tested in trial NCT02723162?
The interventions under investigation include: Placebo (DRUG), N-Acetylcysteine (NAC) (DRUG), Varenicline (VRN) (DRUG).
Who is sponsoring clinical trial NCT02723162?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02723162 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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