Helping patients kick the "other" habit
Chew users want medications—not just counseling. What’s worth trying when the evidence is limited?
A significant difference was found in abstinence rates between patients treated with active therapy compared to those treated with placebo early in the study; however, by study end, there were no significant differences between groups. The medication was well tolerated, though patients receiving active therapy did report an increase in adverse effects related to patch use, such as rash and itching.
TABLE 1
Conflicting findings on the nicotine patch for smokeless tobacco cessation
| STUDY (YEAR) | POPULATION | INTERVENTION | COUNSELING | DURATION | RESULTS | NNT |
|---|---|---|---|---|---|---|
| Howard-Pitney5 (1999) | 420 patients • ≥18 years, nonsmokers • ≥1 can/week | • Nicotine patch (15 mg) • Placebo patch | • Written materials • Telephone contact | 6 months | No significant difference in cessation rates | N/A |
| Hatsukami6 (2000) | 400 patients • 1 can/week | • Nicotine patch (began on 22 mg and tapered to 7 mg by study end) + mint snuff • Nicotine patch (same tapering as above) + no mint snuff • Placebo patch + mint snuff • Placebo patch + no mint snuff | • Written materials • 10 minute behavioral counseling | 10 weeks | Patients receiving active NRT had significantly higher quit rates at 10 and 15 weeks (P=0.002 and 0.016, respectively) | Patients with mint snuff: • 10 weeks: 4.3 • 15 weeks: 5.5 Patients w/o mint snuff: • 10 weeks: 14.3 • 15 weeks: 20 |
| Stotts7 (2003) | 300 patients • 14- to 19- year-old males • ST use ≥5 days/week | • Nicotine patch • Placebo patch • Usual care | • Patch: Six, 50- minute behavioral counseling sessions • Usual care: one, 5- to 10-minute counseling session with one follow-up telephone contact | 1 year | No significant difference in cessation rates at 1 year | N/A |
| Ebbert8 (2007) | 42 patients • ≥18 years, in good health • ≥3 cans or pouches/day | • Nicotine patch (21, 42, or 63 mg/day) • Placebo patch | • None | 3 days | NRT with 42 mg/day provided similar levels of nicotine to active ST users | N/A |
| NNT, number needed to treat; NRT, nicotine replacement therapy; ST, smokeless tobacco. | ||||||
Study #2: Nicotine plus mint snuff. The second trial to evaluate nicotine patches randomized approximately 400 patients to 1 of 4 groups: active nicotine patch plus mint snuff (non-nicotine mint-leaf product), active nicotine patch and no mint snuff, placebo plus mint snuff, or placebo patch and no mint snuff.6 To be enrolled in the study, patients had to use 1 can of smokeless tobacco per week and express a desire to quit. Patients given the active nicotine patch were begun on 22 mg and tapered to 7 mg by the end of 10 weeks. At 10 weeks, continuous abstinence and abstinence since the last clinic visit were evaluated. (Researchers tracked the patients for a total of 62 weeks.)
Patients who received active nicotine patches had significantly higher cessation rates compared to placebo at 10 (P=0.002) and 15 (P=0.016) weeks, but not at any other time during the study. No information regarding adverse effects was reported.
Study #3: Patch in adolescents. In a third, randomized, placebo-controlled trial, the effect of nicotine replacement in adolescents was evaluated. Patients were randomized to an active patch, placebo patch, or usual care (1 counseling session with a follow-up phone call).7
Patients who received an active patch also received 6 weeks of behavior counseling sessions. Smokeless tobacco users were further stratified according to light/moderate or heavy use according to saliva cotinine levels: light/moderate users were started on 14 mg and heavy users on 21 mg of nicotine. All patients were tapered to 7 mg over a 6-week period. Approximately 300 males between the ages of 14 and 19 who used smokeless tobacco at least 5 days a week were enrolled in the study.
Cessation rates at 1 year were not statistically significant between the placebo and active patch (P=0.22). The nicotine patch was well tolerated, with the exception of 5 patients who experienced skin irritation or headache; however, 3 patients were removed from patch therapy due to skin hyper-reaction or headache.
Study #4: Dosing. A fourth study, by Ebbert et al,8 addressed potential under-dosing of nicotine patches. This study was a randomized, double-blind, placebo controlled trial that evaluated 21, 42, or 63 mg/day of nicotine delivered by patch or placebo in 42 patients. (The 21 mg/day dose is the highest recommended starting dose for smokers.) The patients had to be 18 years of age or older, in good health, and use 3 or more cans/pouches of smokeless tobacco per day.
The study took place in 3 phases: outpatient preadmission, inpatient research phase, and an outpatient follow-up phase. The inpatient phase measured nicotine and cotinine concentrations during active smokeless tobacco use and while receiving treatment or placebo. Patients treated with the 42 mg/day patch had levels closer to those measured during active smokeless tobacco use, while patients treated with 63 mg/day tended to be “over-replaced” and experienced more severe adverse effects, such as nausea, vomiting, and headache. Overall, nicotine replacement therapy was well tolerated throughout the trial.
