A number of treatments can help smokers make a successful quit attempt, but many initially
successful quitters relapse over time. Several interventions have been proposed to
help prevent relapse. To assess whether specific interventions for relapse prevention
reduce the proportion of recent quitters who return to smoking. We searched the Cochrane
Tobacco Addiction Group trials register, clinicaltrials.gov, and the ICTRP in May
2019 for studies mentioning relapse prevention or maintenance in their title, abstracts,
or keywords. Randomised or quasi‐randomised controlled trials of relapse prevention
interventions with a minimum follow‐up of six months. We included smokers who quit
on their own, were undergoing enforced abstinence, or were participating in treatment
programmes. We included studies that compared relapse prevention interventions with
a no intervention control, or that compared a cessation programme with additional
relapse prevention components with a cessation programme alone. We used standard methodological
procedures expected by Cochrane. We included 81 studies (69,094 participants), five
of which are new to this update. We judged 22 studies to be at high risk of bias,
53 to be at unclear risk of bias, and six studies to be at low risk of bias. Fifty
studies included abstainers, and 30 studies helped people to quit and then tested
treatments to prevent relapse. Twenty‐eight studies focused on special populations
who were abstinent because of pregnancy (19 studies), hospital admission (six studies),
or military service (three studies). Most studies used behavioural interventions that
tried to teach people skills to cope with the urge to smoke, or followed up with additional
support. Some studies tested extended pharmacotherapy. We focused on results from
those studies that randomised abstainers, as these are the best test of relapse prevention
interventions. Of the 12 analyses we conducted in abstainers, three pharmacotherapy
analyses showed benefits of the intervention: extended varenicline in assisted abstainers
(2 studies, n = 1297, risk ratio (RR) 1.23, 95% confidence interval (CI) 1.08 to 1.41,
I 2 = 82%; moderate‐certainty evidence), rimonabant in assisted abstainers (1 study,
RR 1.29, 95% CI 1.08 to 1.55), and nicotine replacement therapy (NRT) in unaided abstainers
(2 studies, n = 2261, RR 1.24, 95% Cl 1.04 to 1.47, I 2 = 56%). The remainder of
analyses of pharmacotherapies in abstainers had wide confidence intervals consistent
with both no effect and a statistically significant effect in favour of the intervention.
These included NRT in hospital inpatients (2 studies, n = 1078, RR 1.23, 95% CI 0.94
to 1.60, I 2 = 0%), NRT in assisted abstainers (2 studies, n = 553, RR 1.04, 95%
CI 0.77 to 1.40, I 2 = 0%; low‐certainty evidence), extended bupropion in assisted
abstainers (6 studies, n = 1697, RR 1.15, 95% CI 0.98 to 1.35, I 2 = 0%; moderate‐certainty
evidence), and bupropion plus NRT (2 studies, n = 243, RR 1.18, 95% CI 0.75 to 1.87,
I 2 = 66%; low‐certainty evidence). Analyses of behavioural interventions in abstainers
did not detect an effect. These included studies in abstinent pregnant and postpartum
women at the end of pregnancy (8 studies, n = 1523, RR 1.05, 95% CI 0.99 to 1.11,
I 2 = 0%) and at postpartum follow‐up (15 studies, n = 4606, RR 1.02, 95% CI 0.94
to 1.09, I 2 = 3%), studies in hospital inpatients (5 studies, n = 1385, RR 1.10,
95% CI 0.82 to 1.47, I 2 = 58%), and studies in assisted abstainers (11 studies,
n = 5523, RR 0.98, 95% CI 0.87 to 1.11, I 2 = 52%; moderate‐certainty evidence) and
unaided abstainers (5 studies, n = 3561, RR 1.06, 95% CI 0.96 to 1.16, I 2 = 1%)
from the general population. Behavioural interventions that teach people to recognise
situations that are high risk for relapse along with strategies to cope with them
provided no worthwhile benefit in preventing relapse in assisted abstainers, although
unexplained statistical heterogeneity means we are only moderately certain of this.
In people who have successfully quit smoking using pharmacotherapy, there were mixed
results regarding extending pharmacotherapy for longer than is standard. Extended
treatment with varenicline helped to prevent relapse; evidence for the effect estimate
was of moderate certainty, limited by unexplained statistical heterogeneity. Moderate‐certainty
evidence, limited by imprecision, did not detect a benefit from extended treatment
with bupropion, though confidence intervals mean we could not rule out a clinically
important benefit at this stage. Low‐certainty evidence, limited by imprecision, did
not show a benefit of extended treatment with nicotine replacement therapy in preventing
relapse in assisted abstainers. More research is needed in this area, especially as
the evidence for extended nicotine replacement therapy in unassisted abstainers did
suggest a benefit. Do any treatments help people who have successfully quit smoking
to avoid starting smoking again? Background Some people start smoking again shortly
after quitting and are said to have 'relapsed'. Treatments used to help people avoid
relapse usually focus on teaching the skills to cope with temptations to smoke, but
can also involve extending the length of the treatment that helped them to quit, or
giving additional treatment, like follow‐up calls, leaflets, or stop‐smoking medicine.
We set out to see if these types of approaches can be helpful, either for people who
quit on their own or with the help of treatment, or for those who quit because they
were pregnant or in hospital. Study characteristics We updated our searches of research
databases in May 2019. We found 81 studies that tested various ways of trying to help
people who had recently quit smoking not to relapse. Five of them were new for this
update. Fifty studies included people who had already quit, and 30 studies helped
people to quit and then tested treatments to prevent relapse. Twenty‐eight studies
focused on people who needed to stop smoking for a limited period of time because
they were pregnant (19 studies), in hospital (six studies), or because of military
service (three studies). Most of the studies used behavioural support treatments that
tried to teach people skills to cope with the urge to smoke, or followed up with additional
leaflets or calls, internet or mobile phone resources, or additional counselling.
Some studies tested extending the use of medicines for helping people to quit smoking,
in the hope of preventing relapse. Key results The evidence we found does not support
the use of behavioural treatments to help prevent relapse after quitting smoking.
This result was the same in all of the different groups of people studied. The most
promising treatments involved extending treatment with stop‐smoking medicine, in particular,
varenicline. Extending treatment with bupropion did not appear to help and there was
not enough evidence on extending treatment with nicotine replacement therapy. Certainty
of the evidence For behavioural treatments, the certainty of the evidence was moderate.
This is because of the diversity of results among studies. The certainty of evidence
for treatments with quit‐smoking medicines varied. There was moderate‐certainty evidence
for varenicline, moderate‐certainty evidence for bupropion, and low‐certainty evidence
for nicotine replacement therapy (NRT), and for NRT and bupropion together. Certainty
in the evidence was limited by small study sizes.