Advisory Committee Chair
Karen Cropsey
Advisory Committee Members
Burel Goodin
Peter Hendericks
Sylvie Mrug
Jarred Younger
Document Type
Dissertation
Date of Award
2021
Degree Name by School
Doctor of Philosophy (PhD) College of Arts and Sciences
Abstract
Varenicline is one of the most efficacious smoking cessation medications. However, some individuals are unable to adhere to the 12-week medication regimen, primarily due to side effects. Although these side effect may be due to the pharmacological effects of varenicline, there may also be a psychologically rooted explanation (i.e., nocebo effects). Varenicline was once believed to cause serious adverse events and although this has been refuted, concerns regarding its use continue within the general population. This is the first study to differentiate psychological expectancies from pharmacological barriers as it relates to varenicline adherence. Varenicline naïve smokers (N=80) were randomized into a modified balanced placebo design, crossing 2 (given varenicline v. placebo) x 2 (told therapeutic dose v. low dose) to produce four conditions: (1) Told Therapeutic Dose/Varenicline (2) Told Low Dose/Varenicline, (3) Told Therapeutic Dose/Placebo, (4) Told Low Dose/Placebo. Participants self-reported daily medication adherence and other smoking-related outcomes through electronic assessments over two weeks. Results indicated that those in the Told Therapeutic Dose/Varenicline condition had the most stable adherence rates. Conversely, those in the Told Therapeutic Dose/Placebo condition had the sharpest decline in adherence and greatest increase in reported side effects. These reported “side effects” were revealed to be a combination of nocebo effects and misattribution nicotine withdrawal symptoms iv (mainly, nausea, bloating, and increased appetite). Those in the Told Low Dose/Placebo condition provided further evidence that reducing expectations of side effects is associated with higher adherence as well as reduced nocebo effects and withdrawal. Overall, varenicline users who were provided with instructions that reduced expectancies of side effects demonstrated high initial adherence and maintained adherence in the presence of side effects. Ultimately, this suggests that providers would benefit from presenting the potential side effects of varenicline in a careful manner that will diminish negative expectations to help reduce the experience of side effects and improve adherence. Additionally, providing psychoeducation on the temporary nature of withdrawal symptoms may further decrease the likelihood of misattributing minimal withdrawal as a side effect of the medication.
Recommended Citation
Schiavon, Samantha, "Balanced Placebo Design with Varenicline: Pharmacological and Expectancy Effects on Medication Adherence" (2021). All ETDs from UAB. 634.
https://digitalcommons.library.uab.edu/etd-collection/634