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NCT03538808 · ClinicalTrials.gov registry record · Phase 4
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT03538808: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT03538808 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03538808, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
The current study will use the double-blind balanced placebo design to examine differences between expectancies versus the pharmacological effects of varenicline medication administered for two weeks to cigarette smokers. The double-blind balanced placebo design includes medication administration (active medication v. placebo) and medication information (told truth v. deception) resulting in four groups of smokers: (1) told therapeutic dose (TD) medication + received TD medication; (2) told TD medication + received placebo; (3) told low dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo. Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use, and reasons for medication non-adherence.
Primary Outcome
Self-reported medication adherence measured through a single item assessing medication compliance. The item is answered as "yes" (scored as 1) or "no" (scored as 0). This measure combines all responses from Day 1 through Day 13 of this study to provide a total measure of medication adherence ranging from 0% (missed all doses) to 100% (took every dose as prescribed). Higher scores indicate better outcomes (i.e., better adherence to medication).
Interventions
- OTHER Placebo
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2019-10-29 |
| Phase | Phase 4 |
What the finished NCT03538808 record still lists
NCT03538808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03538808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03538808 about?
NCT03538808 is a clinical study titled "Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence". The current study will use the double-blind balanced placebo design to examine differences between expectancies versus the pharmacological effects of varenicline medication administered for two weeks to cigarette smokers. The double-blind balanced placebo design includes medication administration (a...
What is the current status of trial NCT03538808?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2018-11-06. Estimated completion is 2019-10-29.
What interventions are being tested in trial NCT03538808?
The interventions under investigation include: Placebo (OTHER), Varenicline (DRUG).
Who is sponsoring clinical trial NCT03538808?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03538808's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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