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Predictors of post-treatment relapse to smoking in successful quitters: pooled data from two phase III varenicline trials.

ABSTRACT: Identifying predictors of smoking relapse helps to elucidate the challenges of long-term smoking cessation and provides direction for improved treatment development.In this post hoc data analysis, we examined predictors of relapse from end-of-treatment (week 13) through 1-year follow-up (week 52) for treatment-responding participants who achieved the primary efficacy endpoint of 4-week continuous abstinence (weeks 9-12), during two phase III varenicline trials.Of 626 smokers classified as treatment responders for all treatment groups across both trials, 301 (48%) relapsed during follow-up (weeks 13-52). The odds of relapsing were almost 5 times greater (odds ratio [OR]=4.92, 95% confidence interval [CI]: 2.77-8.97; p<.001) for treatment responders who did not initiate continuous abstinence until the final 4 weeks of the treatment period compared with those who initiated continuous abstinence by their quit date. Participants who reported >30 days of abstinence during the year prior to study entry were significantly more likely to relapse than those who reported 0 days of abstinence (OR=2.38, 95% CI: 1.17-5.04; p=.013).Results of these analyses suggest that the ability to quit smoking on the initial quit date and maintain abstinence throughout the treatment period is a good prognostic indicator for long-term abstinence. The relationship between post-treatment relapse and longer pretreatment periods of abstinence is counterintuitive, yet not without precedence in the literature.

SUBMITTER: Heffner JL

PROVIDER: S-EPMC2875368 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature

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Predictors of post-treatment relapse to smoking in successful quitters: pooled data from two phase III varenicline trials.

Heffner Jaimee L JL Lee Theodore C TC Arteaga Carmen C Anthenelli Robert M RM

Drug and alcohol dependence 20100113 1-3

<h4>Background</h4>Identifying predictors of smoking relapse helps to elucidate the challenges of long-term smoking cessation and provides direction for improved treatment development.<h4>Methods</h4>In this post hoc data analysis, we examined predictors of relapse from end-of-treatment (week 13) through 1-year follow-up (week 52) for treatment-responding participants who achieved the primary efficacy endpoint of 4-week continuous abstinence (weeks 9-12), during two phase III varenicline trials. ...[more]

PMID: 20071105

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Project description:BackgroundQuit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence.ObjectiveOur aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently.MethodsThis was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days.ResultsFewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators' posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants' posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant.ConclusionsThe intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and social support. Inactive discussion in the Facebook social group might have attributed to the lower effectiveness.ClinicaltrialClinicaltrials.gov NCT02007369; https://clinicaltrials.gov/show/NCT02007369 (Archived by WebCite® at http://www.webcitation.org/6c3RbltQG).

Project description:There is a significant resumption of smoking following smoking cessation using varenicline. Both smoking cessation medications and counseling have been shown to increase smoking quit rates at one year. Thus, the combination of varenicline and interactive voice response (IVR) telephony followed by extended IVR may further improve smoking cessation rates at one and two years.101 participants were recruited from the community via newspaper advertisement. They attended a group counseling session and were given smoking information booklets from the Canadian Cancer Society. After 12 weeks of varenicline and 9 IVR calls, all participants who had quit smoking were randomized into 2 groups matched by levels of motivation and addiction as per baseline questionnaire score. The intervention group continued to receive bi-weekly IVR support for weeks 13-52. The control group no longer received IVR. The primary end-point was self-reported abstinence and exhaled carbon monoxide levels of less than 10 ppm for weeks 12, 52 and 2 years. Data were analyzed by Fisher's exact test or Wilcoxon rank-sum test.Of the 101 participants, 44 (43%) had stopped smoking after 12 weeks of varenicline and 9 IVR calls. Of these, 23 (52%) were randomized to receive IVR calls from weeks 13 to 52.At 52 weeks, 26 (59%) participants remained smoke-free. Of the 23 with IVR, 12 (52.2%) stopped smoking compared to 14 of 21 (66.7%) without IVR. At 2 years, 40 of the 44 (90.9%) randomized participants were contacted and 24 of the 44 (54.5%) came in for testing. Fourteen (13% of the original cohort, 30% who were abstinent at 12 weeks and 53% who were abstinent at 52 weeks) remained smoke-free. Five of the 23 (21.7%) randomized to IVR and 9 of the 21 (42.9%) randomized to no IVR remained smoke-free at 2 years.In this pilot study of an apparently healthy population, extended IVR did not affect abstinence rates. There was no relapse prevention benefit in offering 9 months of continued IVR to subjects who had stopped smoking after receiving 3 months of varenicline and IVR treatment.ClinicalTrial.gov: NCT00832806.

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Predictors of post-treatment relapse to smoking in successful quitters: pooled data from two phase III varenicline trials.

Publications

Predictors of post-treatment relapse to smoking in successful quitters: pooled data from two phase III varenicline trials.

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