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NCT03507127 · ClinicalTrials.gov registry record · Phase 2
Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
A Phase 2 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03507127: Clinical Trial Phase 2 study, sponsored by Brown University.
NCT03507127 is a Phase 2 study that was terminated before completion, run by Brown University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03507127, a Phase 2 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.
Primary Outcome
Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.
Interventions
- DRUG Placebo
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2019-06-30 |
| Phase | Phase 2 |
Why NCT03507127 stopped before completion
NCT03507127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03507127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03507127 about?
NCT03507127 is a clinical study titled "Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1". Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a ciga...
What is the current status of trial NCT03507127?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-05-01. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03507127?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG).
Who is sponsoring clinical trial NCT03507127?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03507127's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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