drugset / Trial / NCT03538808

Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence

NCT03538808

Phase 4 Completed 80 enrolled University of Alabama at Birmingham
RandomizedFactorialDouble-blindTreatment

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.

Timeline

Start
2018-11-06
Primary completion
2019-10-29
Completion
2019-10-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Varenicline Small molecule

Indications

No indication recorded.