Nicotine Gum Eases Withdrawal in Smokeless Tobacco Cessation

Key Takeaways

• In adults using smokeless tobacco in an Indian dental-clinic randomized comparison, 2 mg nicotine gum did not show a significant abstinence advantage over BISCA behavioral counseling.
• Nicotine gum showed stronger craving control, with 90% of participants classified as craving-free by end of treatment versus 34% with BISCA.
• Across other withdrawal domains, the same direction favored nicotine gum for anxiety and sleep-related symptoms.
• Both interventions were described as well tolerated, and interpretation remains bounded by the trial's single-center design and other author-reported caveats.

Smokeless tobacco use remains a major burden in South and Southeast Asia, where oral lesions, periodontal disease, and cancer risk often bring long-term users into dental clinics. In India, where dental settings directly encounter those consequences, comparative randomized evidence on cessation support remains limited, leaving an open question about whether 2 mg nicotine gum or the Behavioral Intervention for Smokeless Tobacco Cessation for Adults (BISCA) better supports quitting in adults who use smokeless tobacco.

Investigators at Siksha O Anusandhan University conducted a single-center randomized controlled trial in an Indian dental hospital, enrolling 100 adult smokeless tobacco users and assigning them 1:1 to 12 weeks of 2 mg nicotine gum or BISCA behavioral counseling in the Scientific Reports randomized trial of nicotine gum for smokeless tobacco cessation. Participants knew their assigned intervention, but outcome assessors were blinded.

BISCA provided a 30-minute initial counseling session followed by 15-minute follow-up visits at weeks 1, 2, 4, 6, 8, 10, and 12. The nicotine replacement therapy (NRT) arm used 8 to 10 pieces daily, up to 15 per day, for the first 6 weeks with gradual reduction and brief behavioral support. Reported endpoints were 7-day self-reported abstinence at 3 and 6 months, salivary thiocyanate at baseline and 6 months for biochemical verification, and withdrawal symptoms measured with the Minnesota Tobacco Withdrawal Scale (MTWS).

Cessation outcomes were broadly similar between groups. In the abstinence outcomes in the Scientific Reports trial, self-reported abstinence at 3 months was 74% with nicotine gum and 68% with BISCA, while biochemically verified abstinence at 6 months was 46% and 40%, respectively. Neither between-group difference was statistically significant.

Withdrawal control favored nicotine gum, with 90% classified as craving-free by the end of treatment versus 34% with BISCA. The same pattern extended to other MTWS domains, with 98% versus 54% classified as anxiety-free and 100% versus 82% as having no sleep problems. Both interventions were described as well tolerated with minimal adverse events.

Interpretation remains bounded by several author-reported features of the trial: no placebo group, unequal behavioral contact between arms, participant awareness of treatment allocation despite blinded outcome assessment, and single-center dental-hospital conduct in a predominantly male, well-educated sample. The authors also noted that labels such as anxiety-free and insomnia-free reflected absence of moderate-to-severe symptoms on the withdrawal scale rather than complete absence of symptoms, and that salivary thiocyanate is a nonspecific biomarker that can be influenced by diet. They further suggested that dental settings may offer distinctive follow-up opportunities because clinicians can directly demonstrate tobacco-related oral damage.

The authors concluded that 2 mg nicotine gum was linked to better control of several withdrawal symptoms during smokeless tobacco cessation, but it did not establish a statistically significant abstinence benefit over BISCA behavioral counseling. They called for larger dose-response studies with longer follow-up to clarify dosing, duration, and effects on abstinence.

Clinician Questions

How was abstinence defined and verified in the nicotine gum versus BISCA smokeless tobacco trial?

Self-reported abstinence meant no smokeless tobacco use during the previous 7 days at 3- and 6-month follow-up, and biochemical verification used salivary thiocyanate measured at baseline and 6 months. The authors described salivary thiocyanate as a nonspecific biomarker that can be influenced by diet, which affects how verification should be interpreted.

What did “anxiety-free” and “no sleep problems” mean in this smokeless tobacco withdrawal comparison?

Symptoms were measured with the Minnesota Tobacco Withdrawal Scale, and classifications such as anxiety-free and insomnia-free referred to absence of moderate-to-severe symptoms rather than complete absence of all symptoms.

Which smokers or tobacco users do the nicotine gum findings most directly apply to?

These findings most directly apply to adult smokeless tobacco users treated in a single dental hospital in India, where participants were described as predominantly male and well educated. That study population narrows how broadly the results can be generalized to other tobacco-using groups and practice settings.

Why might nicotine gum have improved withdrawal symptoms without showing a clear abstinence advantage?

The researchers suggested that prolonged nicotine exposure from smokeless tobacco may be associated with nicotine receptor upregulation, which could help explain stronger control of craving and anxiety with nicotine replacement therapy. They also noted that craving was a common reason for relapse among participants with prior quit attempts and that the absence of a significant abstinence difference may reflect the relatively small sample size.