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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 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 80 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03538808
The ClinicalTrials.gov registry entry for NCT03538808 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03538808 reports 0 study locations.
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.
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