Understanding the correlates of successful abstinence in a randomized double blind placebo controlled trial of varenicline for smokeless tobacco dependence in India
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1
All India Institute of Medical Sciences, Psychiatry (NDDTC), India
2
All India Institute of Medical Sciences, Center for Dental Education and Research, India
3
University of Pennsylvania, Department of Psychiatry, United States of America
Publication date: 2018-03-01
Tob. Induc. Dis. 2018;16(Suppl 1):A350
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ABSTRACT
Background:
Rates
of smokeless tobacco(ST) use in India are very high and associated with grave
health consequences. Research on effective ST cessation approaches is a
priority. In a randomized double blind placebo controlled trial of varenicline for ST dependence in AIIMS, India,
biochemically confirmed end-of-treatment(EOT) abstinence was greater for
varenicline versus placebo(25.2% vs. 19.5%), but this was not statistically
different(AOR = 1.6, 95% CI = 0.84-3.1, p = .15). Here, we studied the correlates of successful abstinence in
this trial as such an evidence-base is crucial to optimize treatment
strategies.
Methods:
237 ST users
who were randomized to receive either varenicline(12 weeks, 1 mg, twice per
day) or placebo were included in this analysis. Socio-demographics, ST use
parameters (age of initiation, duration, chews per day, and FTND-ST scores), abstinence
related parameters, baseline urinary cotinine levels, and treatment adherence
were analyzed. Multivariate analysis, using biochemically confirmed point
prevalence abstinence as the dependent variable, was done to predict the odds
of quitting at EOT.
Results:
Participants were predominantly
males(97%) and mean age was 34.2(SD± 9)yrs. Using logistic regression on the
whole group, baseline urinary cotinine and number of 24 hour quit attempts in
the past significantly(p < 0.05)
predicted cessation at EOT. The odds of abstinence increased with unit decrease
in urinary cotinine levels(Exp(B) = 0.86) and unit increase in number of 24
hour quit attempts (Exp(B) = 0.66). In the varenicline arm average chews per
day(Exp(B) = 0.91) and baseline depression scores using HAM-D also
significantly predicted successful quitting. Greater adherence increased EOT
cessation rates for varenicline (39% vs. 18%, p = .003) but not for placebo
(28% vs. 14%, p = .06).
Conclusions:
This has implications for
optimizing treatment planning at a program level, especially in resource poor
countries. Strategies to enhance treatment adherence and address depression
would be important.