CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03538808
NCT03538808Phase 4Completed

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

University of Alabama at Birmingham·interventional·Posted May 29, 2018·Updated Dec 14, 2020

In Brief

A Phase 4 clinical trial evaluating Varenicline and Placebo for Medication Adherence. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 29, 2018
Enrollment StartNov 6, 2018
Primary CompletionOct 29, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.1 years ago

Interventions

Vareniclinedrug

Participants will be provided varenicline medication

Placeboother

Participants will be provided placebo medication