In a dental clinic trial, nicotine gum substantially reduced craving, anxiety, and sleep problems, but its apparent advantage in helping people quit smokeless tobacco remains unproven.

Nicotine gum manages key withdrawal symptoms more effectively than behavioral counseling during smokeless tobacco cessation, according to a new study published in the journal Scientific Reports.

Background

More than 300 million individuals use smokeless tobacco worldwide, making it a major public health challenge. The burden is highest in South and Southeast Asian populations. Traditional smokeless products, such as gutka, khaini, paan masala, and zarda, are deeply embedded in Asian cultural and social practices, making it challenging to encourage people to quit them.

Unlike combustible tobacco use, smokeless tobacco use is associated with direct contact of nicotine with oral and nasal mucosa, leading to sustained nicotine absorption and distinct patterns of dependence. Smokeless tobacco products can significantly increase the risk of oral mucosal lesions, tooth loss, gum disease, and oral cancer. Use of these products is also associated with cardiovascular disease, stroke, and adverse pregnancy outcomes.

Despite the high prevalence of smokeless tobacco use in Asian countries, particularly in India, adequately powered randomized controlled trials directly comparing cessation interventions are lacking within dental settings.

Given the lack of knowledge regarding optimal cessation interventions, researchers at the Siksha O Anusandhan University, India, conducted a single-center randomized controlled trial in which participants knew their assigned intervention, but outcome assessors were blinded to compare the effectiveness of nicotine replacement therapy and the Behavioral Intervention for Smokeless Tobacco Cessation for Adults (BISCA) intervention in smokeless tobacco cessation in a dental clinic.

Trial design

A total of 100 adult users of smokeless tobacco were enrolled in the trial. They were randomized in a 1:1 ratio to receive either 2 mg nicotine gum or behavioral counseling for a period of 12 weeks.

Participants in the behavioral intervention group underwent an initial 30-minute counseling session, followed by follow-up sessions at weeks 1, 2, 4, 6, 8, 10, and 12, each lasting 15 minutes. Participants in the nicotine replacement therapy group were instructed to use 8 to 10 pieces of nicotine gum daily, with a maximum of 15 pieces per day, for the initial 6 weeks, followed by a gradual reduction in subsequent weeks. They also received brief behavioral support lasting 5 to 10 minutes at each visit.

Salivary thiocyanate levels were measured at baseline and at 6-month follow-up for biochemical verification of tobacco abstinence. Self-reported tobacco abstinence was also assessed at 3-month and 6-month follow-ups, with abstinence defined as no smokeless tobacco use during the previous seven days. The Minnesota Tobacco Withdrawal Scale was used to assess participants’ withdrawal symptoms.

Key findings

Both groups achieved substantial tobacco cessation outcomes after the end of the intervention period, with no significant differences between the two groups.

Self-reported abstinence at 3 months was 74% in the nicotine gum group and 68% in the behavioral counseling group. Biochemical verification of abstinence at 6 months, however, showed that 46% of nicotine gum users and 40% of behavioral counseling participants were biochemically classified as abstinent at the 6-month assessment. Neither the between-group difference was statistically significant.

Regarding management of withdrawal symptoms, nicotine gum was significantly more effective than behavioral counseling in controlling cravings and anxiety and reducing sleep problems. At the end of treatment, 90% of participants receiving nicotine gum versus 34% of BISCA participants were classified as craving-free, 98% versus 54% as anxiety-free, and 100% versus 82% as having no sleep problems.

Significance

The trial finds nicotine replacement therapy to be more effective than behavioral counseling for managing several key withdrawal symptoms of smokeless tobacco cessation, including cravings, anxiety, and sleep disturbances. However, it did not demonstrate a statistically significant improvement in abstinence rates. Both interventions were well-tolerated with minimal adverse events.

Both self-reported and biochemically verified tobacco abstinence rates were numerically higher among individuals who received nicotine gum compared to those who underwent behavioral counseling. The lack of statistically significant differences in abstinence rates between the two intervention groups may be due to the relatively small sample size.

Among the 47 participants with previous quit attempts, 47.9% reported craving as the leading cause of relapse. Nicotine replacement therapy using nicotine gum was significantly more effective than behavioral counseling in controlling this key symptom.

The researchers suggest that prolonged nicotine exposure patterns associated with smokeless tobacco use may be associated with substantial nicotine receptor upregulation. This may explain the stronger control of cravings and anxiety observed with nicotine replacement.

The observed benefits in anxiety management in nicotine gum users also suggest, according to the authors, that pharmacological interventions may better address underlying neurochemical withdrawal mechanisms that counseling cannot fully manage.

The observed improvement in sleep quality in nicotine gum users may be due to the reduction of overall withdrawal discomfort. Collectively, these findings support comprehensive withdrawal management rather than symptom-specific approaches. The study notes that classifications such as “anxiety-free” and “insomnia-free” reflected the absence of moderate-to-severe symptoms on the withdrawal scale rather than necessarily the complete absence of all symptoms.

Larger dose-response studies with longer follow-up are needed to optimize nicotine replacement therapy dosing and duration for smokeless tobacco users who, unlike smokers, experience prolonged nicotine exposure through the oral mucosa.

The trial was conducted in a single dental hospital setting, and the participants were predominantly male and well educated. These factors may limit the generalizability of the findings to other demographics. The authors also note that dental settings may offer particular advantages for cessation programs because clinicians can directly demonstrate tobacco-related oral damage and provide repeated follow-up.

Salivary thiocyanate is a non-specific biomarker and may be influenced by dietary components, limiting its accuracy in verifying tobacco abstinence. Notably, the trial lacked a placebo group, and the two groups received different amounts of behavioral contact, with BISCA participants receiving longer counseling sessions than nicotine gum participants. These differences could have introduced performance bias, while participants’ awareness of treatment allocation may also have influenced expectations. This is particularly relevant for a trial in which participants were aware of their assigned treatment, although outcome assessors remained blinded.

Journal reference:

• Pradhan, S., Priyadarshini, S. R., Misra, S. R., Panigrahi, R., & Choudhary, B. (2026). Effectiveness of nicotine gum for intervention and role of behavior counselling for smokeless tobacco cessation in adults in a dental setting: A randomized control trial. Scientific Reports. DOI:10.1038/s41598-026-65226-9, https://www.nature.com/articles/s41598-026-65226-9