Overview
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
Status:
Completed
Completed
Trial end date:
2019-10-29
2019-10-29
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of Alabama at BirminghamTreatments:
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