Gradual Vs. Abrupt Smoking Cessation

In Review

Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P. "Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority Trial". Ann Intern Med. 2016. 164(9):585-592.
PubMed • Full text

Clinical Question

For an adult patient addicted to smoking tobacco, would a gradual course of quitting result in more long term success as compared to quitting smoking abruptly?

Bottom Line Recommendation

In patients who are addicted to tobacco, there is significant evidence suggesting that quitting smoking abruptly after pre-cessation NRT results in more short and long term success as compared to quitting smoking gradually.

Major Points

Worldwide guidelines for smoking cessation generally recommend abrupt cessation and do not support a gradual reduction in smoking. Evidence supporting the superiority of either gradual decrease or abrupt cessation is conflicting. A Cochrane review in 2012 of 10 randomized trials including 3760 patients suggest that the difference in quit rates achieved using 2 approaches is slight with an overall relative risk of 0.94 (95% CI, 0.79 to 1.13). This did not change when pharmacotherapy was used (RR= 0.87, 95% CI= 0.65 to 1.22), or not (RR= 0.97, 95% CI= 0.78 to 1.21), or when combined with behavioural support (RR= 0.87, 95% CI= 0.64 to 1.17) or self-help therapy (RR= 0.98, 95% CI= 0.78 to1.23).

Published in 2016, this un-blinded study randomized 697 patients with a tobacco addiction into groups of abrupt smoking cessation and gradual smoking cessation in combination with behavioural supports. This trial was conducted in order to determine whether an initial gradual reduction in smoking is non-inferior to quit rates in patients who stop smoking abruptly. The primary outcome was prolonged validated abstinence from smoking 4 weeks after quit day. Secondary outcomes included 8 week Russell-standard abstinence and prolonged, validated, 6-month abstinence. The primary outcome showed that abrupt-cessation group had a higher abstinence rate compared to that of the gradual-cessation group. Secondary outcomes had similar results.

The trial is randomized, however there was no blinding with either of the groups. Most of the participants were white and British (94%); therefore, limited generalizations can be made within other minority populations or geographic locations. The use of pre-cessation NRT also limits its application when NRT is not used prior to the quit date.

Guidelines

NICE Guidelines (2013)

• Suggest that patient should be able to choose whether to quit gradually or abruptly.
• Results from the mentioned study suggest that patients should be encouraged to quit abruptly and not gradually.
• Quitting gradually may still be effective if patient utilizes support methods and medication.

Study Design

• Randomized, controlled noninferiority trial
• N=697

• Abrupt (N=355)

• Gradual (N=342)

• Setting: 31 primary care clinics in England
• Enrollment: 2009 to 2011
• Follow Up: 6 months
• Analysis: Intention-to-treat
• Primary Outcome: Russell Standard 4-week abstinence
• Secondary Outcomes: Russell Standard 8-week abstinence and 6-month abstinence

Population

Inclusion Criteria

• Adult smokers who are addicted to tobacco

• Tobacco addiction was defined as smoking at least 15 cigarettes per day or 12.5g of loose-leaf tobacco daily

• End-expiratory carbon monoxide concentration of at least 15ppm.

• Willing to quit smoking two weeks after being enrolled in the trial.
• Persons who were dependent on alcohol or illicit drugs or with psychiatric conditions were included, unless their conditions were severe

Exclusion Criteria

• Current enrollment in another cessation program
• Participation in other medical trials
• Contraindications to nicotine replacement therapy (NRT)
• Inability to meet the demands of the trial

Baseline Demographics

• Median Age: 49 years

• Male: 50.2%

• White Ethnicity: 93.6%

• Postsecondary school (15-16 years of age): 50.9%

• Paid employment: 55.3%

• Median age started smoking: 16 years of age

• Lives with a smoker: 38.7%

• Median previous quit attempts: 2.0

• Median cigarettes per day: 20.0

• Median expired Carbon Monoxide (ppm): 24.0

• Type of cigarette smoked:

• Manufactured 76%

• Hand rolled 19.7%

• Both 4.3%

• Preference:

• Abrupt cessation group 32.1%

• Gradual cessation group 50.9%

• No preference 16.9%

• Median confidence in quitting: 4

• 1-very low, 6-extremely high

Interventions

Randomization to assign adult smokers to gradual reduction of tobacco use over 2 weeks before a planned quit date or abrupt cessation of smoking on a planned quit date

• Gradual Cessation

• Reduce smoking to half by the end of the 1st week and to quarter of baseline at the end of the second week

• Participants chose one of the three structured reduction programs: Hierarchical, scheduled, or smoke-free periods

• Received nicotine patches (21mg/d) and a choice of short-acting NRT product.

• Abrupt-Cessation

• Smoke normally and no reducing until the quit date

• Before quitting, nicotine patches were used

• Both groups had the same treatment program including:

• Research Nurse Visitation

• Behavioral support

• Withdrawal-oriented therapy

• Pharmacotherapy same for groups from quit day onward

Outcomes

Primary Outcome

4-week Russell Standard abstinence

• Russell Standard allows for 2 week grace period from quit day for slips and intention-to-treat approach that assumes persons lost to follow up are smokers and validated by exhaled CO concentration of less than 10 ppm

• 39.2% gradual vs 49.0% abrupt (adjusted RR, 0.80 (95% CI, 0.66-0.93))

• NNT= 10

Secondary Outcomes

8-week Russell Standard abstinence

• 29.2% gradual vs. 36.6% abrupt (adjusted RR, 0.80 (95% CI, 0.63-0.95))

• NNT= 14

6-month abstinence

• 15.5% gradual vs. 22.0% abrupt (adjusted RR, 0.71 (95% CI, 0.46-0.91))

• NNT=15

Subgroup Analyses

Visit attendance and adherence

• Attendance at Visit 0 (immediately before quit day)

• 82% gradual vs 85.6% abrupt (p=0.147)

• Attendance at Visit 1

• 67.0% gradual vs 83.4% abrupt (p<0.001)

• Self-reported quit attempt greater than or equal to 24 hours or self-reported abstinence

• 61.4% gradual vs 71% abrupt (P=0.007p)

• Relapse rates

• At 4 weeks:

• 36.2% gradual vs 31.0% abrupt (P=0.28)

• At 6 months:

• 74.8% gradual vs 69.1% (P=0.21)

Post quit urges and withdrawal symptoms

• No evidence of difference between groups in withdrawal symptoms or urge intensity (withdrawal symptoms P=0.29; urge intensity P=0.154), both of which decreased over time.

• At week 4, there were no significant differences between groups in withdrawal symptoms (mean difference, 0.08, CI -0.03 to 0.19) and urge intensity (mean difference, 0.05, CI -0.06 to 0.17) scores.

Adverse Events

• No additional serious adverse events were determined to be study-related.
• 3 serious adverse events in gradual-cessation group when patient was using NRT and concurrently smoking

• Shoulder arthroscopy, hospitalization due to salivary gland calculus, hospitalization due to ovarian cyst

• 1 serious adverse event in abrupt-cessation group

• Orchiectomy

• In patients using NRT while still smoking, nicotine overdose symptoms were uncommon, mild, and did not differ by group.
• Salivating and cold sweats were more common in gradual-cessation group than abrupt in pre-quit weeks.

Criticisms

• There was no blinding performed for this randomized control trial.
• Generalizability limilted due to:
  • Most participants were white from England, with only 6% of the trial population being made up of non-white individuals.
  • NRT was initiated prior to the quit date and cannot be applied to programs where the traditional NRT-start after cessation was conducted.

Funding

• This trial was funded by the British Heart Foundation.