A randomised clinical trial of nicotine patches for treatment of spit tobacco addiction among adolescents

Abstract

Background: This study tested the efficacy of nicotine patches in combination with behavioural therapy for the treatment of adolescent spit tobacco addiction. Prior interventions had resulted in mean cessation rates below 15% at one year. Methods: This study, the PATCH Project, used a three group, placebo controlled, randomised clinical trial design. The control group received a standard 3-5 minute counselling followed by a two week follow up phone call. The two intervention groups received a six week behavioural intervention; in addition, one group received active nicotine patches while the other group received placebo patches. Both groups received quarterly stage based telephone counselling. Results: At one year, the usual care group's spit tobacco cessation rate was 11.4% (exact 95% confidence interval (CI) 6.1% to 19.1%), placebo patch 25.0% (95% CI 16.9% to 34.7%), and the active patch 17.3% (95% CI 10.4% to 26.3%). When both patch groups were combined, the cessation rate was 21.2% (95% CI 15.7% to 27.6%). The cessation rates for active and placebo patch were not significantly different (exact two sided p = 0.22), while the combined patch groups had a significantly greater cessation rate than usual care (exact two sided p = 0.04). Conclusions:The behavioural intervention proved to be about twice as successful as previous interventions, but the nicotine patch offered no improvement in cessation rates. The behavioural intervention is based on publicly available materials and can be easily adapted for widespread use, particularly in high schools.

Smoking Rates and the State of Smoking Interventions for Children and Adolescents With Chronic Illness

“…[152][153][154][155] Assessment of nicotine dependence among adolescents has been difficult and controversial because of the varying subjective criteria used for defining dependence and the widely varying sample characteristics. 156,157 Unlike adults, adolescent smokers are also more likely to be influenced by behavioral and social factors than addiction to nicotine.…”

Randomized, Double-blind, Placebo-Controlled Trial of 2 Dosages of Sustained-Release Bupropion for Adolescent Smoking Cessation

“…Other nicotine patch trials for adolescent smoking cessation have failed to show significant differences among treatment groups. [14][15][16][17] Bupropion hydrochloride, the first nonnicotine medication approved for smoking cessation, was an important advance in adult treatment of tobacco dependence and has been studied in 2 recent cessation trials for adolescents. An open-label feasibility study of sustained-release (SR) bupropion hydrochloride in adolescents with comorbid attentiondeficit/hyperactivity disorder (ADHD) and nicotine dependence showed significant decreases in cigarettes smoked (PϽ.001) and carbon monoxide levels (P=.04) during the course of 6 weeks of treatment (150 mg twice daily), and abstinence rates of 31.25% after 4 weeks of treatment.…”

Smokeless tobacco cessation in South Asian communities: a multi‐centre prospective cohort study

“…Results from other smokeless tobacco trials have reported the value of NRT in reducing withdrawal symptoms and NRT-related adverse events during quit attempts [13][14][15][16][17][18][19]. Participant satisfaction with English NHS SSS has been reported previously to be high [23,33].…”

“…NRT patch and gum use was observed to reduce withdrawal symptoms both in range and intensity compared to placebo. NRT-related adverse events were reported as minimal, more likely to be heartburn or gastroesophageal reflux if lozenges were used [13][14][15][16][17][18][19].…”