Short CommunicationA pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users
Introduction
Long-term use of smokeless tobacco (ST) may increase the risk for oral (Stockwell & Lyman, 1986), kidney (Muscat, Hoffmann, & Wynder, 1995) and pancreatic (Muscat, Stellman, Hoffmann, & Wynder, 1997) cancer. Long-term ST use is associated with death from coronary heart disease (CHD) and stroke (Henley, Thun, Connell, & Calle, 2005). However, few cessation resources are available for ST users. Clinic-based resources are not widely available and may not be accessed by ST users who tend to be young, rural males rarely seeking routine medical care (Ebbert, Carr, & Dale, 2004). Given the lower prevalence of past month ST use compared to cigarette smoking among individuals ≥ 12 years of age (3.5% vs. 23.9%) (Substance Abuse and Mental Health Services Administration, 2009) and the unique nature of this population of tobacco users, affordable, effective and disseminable interventions for ST users are needed.
In our previous work, subjects receiving a self-help manual plus two support phone calls [i.e., assisted self-help (ASH)] had significantly higher rates of abstinence at 6 months from ST and all tobacco compared to subjects who received only a self-help manual (Severson et al., 2000). In a different study, nicotine lozenge was observed to be effective for increasing ST abstinence rates and decreasing withdrawal and craving (Ebbert et al., 2007). The combination of an ASH intervention with mailed nicotine lozenge may provide the public health community with a cost-effective intervention combining behavioral and pharmacologic approaches for treating ST use.
We conducted a clinical pilot study to assess the feasibility and safety of mailed nicotine lozenges with an ASH intervention for ST users.
Section snippets
Study design
This study was a randomized, placebo-controlled clinical trial enrolling 60 ST users. Subjects were randomized to the 4-mg nicotine lozenge or placebo for 12 weeks with follow-up to 6 months. All subjects also received an assisted self-help (ASH) intervention.
The study was conducted at the Mayo Clinic in Rochester, MN, and the Oregon Research Institute (ORI) in Eugene. The Institutional Review Boards at each study site approved the study protocol prior to subject recruitment. Enrollment took
Subjects
Of 60 individuals screened, 60 subjects were eligible and randomized to receive treatment (30 lozenge, 30 placebo) and included in the final analysis. Subjects were similar at baseline (Table 2). The overall study drop-out rate was 22% at 6 months.
Lozenge use
During the first week there were 2 subjects (1 in each treatment group) who reported using more than 16 lozenges per day. No subjects reported using more than 16 lozenges per day after the first week. For both groups, median lozenge use for the first
Discussion
Mailing nicotine lozenges with an assisted self-help intervention (ASH) is a feasible and safe approach to treating ST users. Lozenge use, treatment adherence, and protocol completion were comparable to clinical trials with more intensive and consistent contact. The nicotine lozenge decreased withdrawal symptoms.
Except for the in-person baseline assessment which was conducted for safety, our approach of mailing nicotine lozenges and providing telephone support models a telephone quitline (QL)
Role of Funding Sources
The project described was supported by Award Number CA 121165 from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. The funding source had no role in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the paper for publication.
Contributors
All authors were directly involved and contributed substantially to the project design. DRS conducted the statistical analyses. JOE wrote the first draft of the manuscript and all authors contributed to and approved the final manuscript.
Conflict of Interest
None to declare.
Acknowledgements
We would like to thank the subjects who participated in this research and the staff of the Mayo Clinic Nicotine Research Program and the Oregon Institute Research staff without whom this project would not have been possible.
Research Performance Sites: Mayo Clinic College of Medicine; 200 1st Street Southwest, Rochester, MN 55905, USA and Oregon Research Institute; 1715 Franklin Blvd, Eugene, OR 97403, USA.
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