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

Completed · Phase 4 · Has a placebo group

Conditions studied: Medication Adherence

In brief

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.

Key facts

Study ID

NCT03538808

Run by

University of Alabama at Birmingham

People needed

80

Starts

2018-11-06

Expected to finish

2019-10-29

Last updated by the study team

2020-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years or older
• Smoking at least 5 cigarettes per day (cpd) for the past year
• A carbon monoxide (CO) >10ppm
• English speaking
• Must own a cellphone with SMS text capacity with Internet access OR daily use of email
• Must be varenicline naïve
• Express a desire to quit smoking

You may not qualify if…

• Living in a restricted environment (e.g., prison or jail facility, etc.)
• Pregnant or nursing
• Currently enrolled in a smoking cessation treatment program, using NRT products, or prescribed bupropion or varenicline
• Known allergy to varenicline
• History of kidney disease, dialysis or known kidney impairment
• Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
• Daily or exclusive use of other tobacco products
• Current suicidal or homicidal ideation or a suicidal attempt within the past 12 months
• History of stroke, heart attack, or seizures

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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