Phase 4
N=80
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT03538808 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Medication Adherence — 85.36; 86.79; 81.93; 86.09 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence |
85.36; 86.79; 81.93; 86.09 | — |
| SECONDARY Medication Expectancies |
3.56; 3.65; 3.50; 3.44 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03538808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.