TY - JOUR
T1 - Seeing Through the Blind
T2 - Belief About Treatment Randomization and Smoking Cessation Outcome Among People With Current or Past Major Depressive Disorder Who Smoke in a Placebo-Controlled Trial of Varenicline
AU - Schnoll, Robert
AU - Wileyto, E. Paul
AU - Bauer, Anna Marika
AU - Fox, Erica N.
AU - Blumenthal, Daniel
AU - Quinn, Mackenzie Hosie
AU - Leone, Frank
AU - Huffman, Mark D.
AU - Khan, Sadiya S.
AU - Gollan, Jacqueline K.
AU - Papandonatos, George D.
AU - Hitsman, Brian
N1 - Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.
PY - 2024/5/1
Y1 - 2024/5/1
N2 - Introduction: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. Aims and Methods: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. Results: Treatment arm belief was significantly associated with actual arm assignment (χ2(2) = 13.0, p = .002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, versus “not sure” (RR = 3.05 [1.41–6.60], p = .005). Participants in the placebo arm were just as likely to believe they were taking placebo versus “not sure” (χ2[2] = 0.75, p = .69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR = 5.91 [2.06–16.92], p = .001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline (B = 0.077 [0.002–0.192], p < .05). Conclusions: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.
AB - Introduction: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. Aims and Methods: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. Results: Treatment arm belief was significantly associated with actual arm assignment (χ2(2) = 13.0, p = .002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, versus “not sure” (RR = 3.05 [1.41–6.60], p = .005). Participants in the placebo arm were just as likely to believe they were taking placebo versus “not sure” (χ2[2] = 0.75, p = .69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR = 5.91 [2.06–16.92], p = .001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline (B = 0.077 [0.002–0.192], p < .05). Conclusions: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.
UR - http://www.scopus.com/inward/record.url?scp=85191106092&partnerID=8YFLogxK
U2 - 10.1093/ntr/ntad218
DO - 10.1093/ntr/ntad218
M3 - Article
C2 - 37934573
AN - SCOPUS:85191106092
SN - 1462-2203
VL - 26
SP - 597
EP - 603
JO - Nicotine and Tobacco Research
JF - Nicotine and Tobacco Research
IS - 5
ER -