Helping patients kick the &quot;other&quot; habit

,

Applied Evidence

Helping patients kick the "other" habit

J Fam Pract. 2008 April;57(4):238-245

PDF Download

References

1. National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Tobacco Use: Prevention, Cessation and Control. Ann Intern Med 2006;145:839-844.

2. Substance Abuse and Mental Health Services Administration. Results from the 2006 National Survey on Drug Use and Health: National Findings. Available at: www.oas.samhsa.gov/nsduh/2k6nsduh/2k6results.pdf. Accessed February 26, 2008.

3. Teo KK, Ounpuu S, Hawken S, et al. Tobacco use and risk of myocardial infarction in 52 countries in the INTERHEART study: a case-control study. Lancet. 2006;368:647-658.

4. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service; 2000.

5. Howard-Pitney B, Killen JD, Fortmann SP. Quitting Chew: Results from a Randomized Trial Using Nicotine Patches. Exp Clin Psychopharmacol. 1999;7:362-371.

6. Hatsukami DK, Grillo M, Boyle R, et al. Treatment of Spit Tobacco Users with Transdermal Nicotine System and Mint Snuff. J Consult Clin Psychol. l2000;68:241-249.

7. Stotts RC, Roberson PK, Hanna EY, Jones SK, Smith CK. A Randomised Clinical Trial of Nicotine Patches for Treatment of Spit Tobacco Addiction Among Adolescents. Tob Control. 2003;12(S4):iv11-15.

8. Ebbert JO, Post JA, Moyer, TP, et al. Nicotine percentage replacement among smokeless tobacco users with nicotine patch. Drug Alcohol Depend. 2007;89:223-226.

9. Boyle RG. Smokeless Tobacco Cessation with Nicotine Replacement: A Randomized Clinical Trial. Dissertation Abstracts International. 1992;54:825.-

10. Hatsukami D, Jensen J, Allen S, Grillo M, Bliss R. Effects of Behavioral and Pharmacological Treatment on Smokeless Tobacco Users. J Consult Clin Psychol. 1996;64:153-161.

11. Zyban [package insert]. Research Triangle Park, NC: GlaxoSmithKline; August 2007.

12. Berigan TR, Deagle EA. Treatment of Smokeless Tobacco Addiction with Bupropion and Behavior Modification. J Am Med Assoc. 1999;281:233.-

13. Glover ED, Glover PN, Sullivan CR, Cerullo CL, Hobbs G. A Comparison of Sustained-Release Bupropion and Placebo for Smokeless Tobacco Cessation. Am J Health Behav. 2002;26:389-393.

14. Dale LC, Ebbert JO, Schroeder DR, et al. Bupropion for the Treatment of Nicotine Dependence in Spit Tobacco Users: A Pilot Study. Nicotine Tob Res. 2002;4:267-274.

15. US Food and Drug Administration. FDA Approves Novel Medication for Smoking Cessation. Available at: www.fda.gov/bbs/topics/NEWS/2006/NEW01370.html. Accessed March 6, 2007.

16. Chantix [package insert]. New York, NY: Pfizer Labs; January 2008.

Correspondence Terri M. Wensel, PharmD, 316 North Main Street, Campus Box 3087, Wingate, NC 28174; twensel@wingate.edu.

Nicotine gum: No lasting benefit

The earliest trial to evaluate nicotine gum for smokeless tobacco cessation was conducted by Boyle⁹ and was only available in abstract form (TABLE 2). This randomized, double-blind, placebo-controlled trial evaluated 2 mg of nicotine gum vs placebo in 100 patients. The main outcome was quit rates at the end of 6 weeks. The quit rate was similar for each group, and did not reach statistical significance (no P value provided). No information regarding adverse effects was reported.

A second trial¹⁰ to evaluate nicotine gum was also a randomized placebo-controlled trial that enrolled just over 200 adult patients that used ≥1 tin of smokeless tobacco per week (TABLE 2). Patients were randomized to 2 mg of nicotine gum or placebo and group therapy sessions or minimal behavioral intervention contact for a 2-month treatment period.

This trial did show a significant difference at week 4 (P<0.01) in point prevalence abstinence—that is, the number of people reporting to be abstinent at the 4-week mark, regardless of whether their abstinence was continuous or not. Significance, however, was lost by week 8. Cessation rates were also significant at 1- and 6-month follow-up exams (P<0.05), but were not maintained at the 12-month follow-up.

TABLE 2
Nicotine gum for smokeless tobacco cessation: Benefit doesn’t last

STUDY (YEAR)	POPULATION	INTERVENTION	COUNSELING	DURATION	RESULTS	NNT
Boyle⁹ (1992)	100 patients	• Nicotine gum (2 mg) • Placebo gum	• Weekly group meetings	6 weeks	No significant difference at 6 weeks	N/A
Hatsukami¹⁰ (1996)	200 adult patients • ≥1 tin/week	• Nicotine gum (2 mg) • Placebo gum	• 8 group therapy sessions or • Minimal behavioral intervention	12 months (8 weeks of treatment)	Point prevalence abstinence* significantly different at 4 weeks (P<0.01); no significant difference at 8 weeks	• Patients in group therapy at 4 weeks: 42 • Patients with minimal intervention at 4 weeks: 7.8
NNT, number needed to treat.
* Point prevalence abstinence is the number of patients reporting to be abstinent on a given day.

Continuous abstinence rates were similar for all groups except the 2 mg nicotine and minimal intervention group. Patients in this group had significantly lower abstinence rates from all other groups (P<0.003). No information regarding adverse effects was reported.

FAST TRACK

Given its utility for smoking cessation, bupropion may be effective for the treatment of smokeless tobacco

Case report suggests bupropion has potential

Bupropion is a non-nicotine smoking cessation therapy that inhibits the uptake of norepinephrine and dopamine. It is unclear how bupropion aids in smoking cessation, though its ability to do so appears to be related to its dopaminergic properties.¹¹

Given its utility in treatment for smoking cessation, it seems plausible that the drug may serve as an effective treatment for smokeless tobacco, as well. However, the literature regarding the use of bupropion for smokeless tobacco cessation is even more limited than that for nicotine replacement therapy.

Berigan and Deagle first described the use of bupropion for smokeless tobacco cessation in 1999 (TABLE 3).¹² Their case report focused on a 31-year-old man who reported using 1 can of smokeless tobacco per day for 11 years. The patient reported having tried nicotine patches and attempting to quit “cold turkey,” with limited success.

The patient was started on a trial of bupropion along with approximately 1 month of behavioral counseling. After 1 week of medication, the patient reported a reduction in cravings. By 5 weeks, the patient reported no use of smokeless tobacco. A total of 10 weeks of medication was given to the patient and he experienced no withdrawal effects after cessation. At 8 months, the patient was still tobacco free. The patient also reported few adverse effects from bupropion.

FAST TRACK

Patients who use 3 or more cans of smokeless tobacco a day may require a 42 mg/day patch

2 bupropion clinical trials are less encouraging

We found 2 clinical trials evaluating sustained-release bupropion 300 mg/day (TABLE 3). The first was a randomized, placebo-controlled trial in which patients received 7 weeks of active or placebo medication, and were then followed (with minimal counseling) for an additional 5 weeks.¹³ A total of 70 men, 18 years of age and older, were enrolled in the study; all had expressed a desire to quit and used at least one-half can of smokeless tobacco a day in the past year.

The primary endpoint was smokeless tobacco abstinence during weeks 4 through 7 of the trial. At the end of week 7 (end of treatment), significantly more patients in the treatment group were free of smokeless tobacco, compared to the placebo group (OR=2.73; 95% CI, 1.07-7.72; P=0.04). However, significance was lost by week 12 (OR=1.93; 95% CI, 0.71-5.47; P=0.2). Bupropion was well tolerated throughout this trial and no serious adverse effects were reported.