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

• Status: Completed
• Trial end date: 2019-10-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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