Preloading With Nicotine Replacement Therapy in People With HIV Who Smoke: A Pilot Randomized Controlled Trial.

INTRODUCTION: Smoking cessation rates in people with HIV (PWH) are lower than in the general population, even when evidence-based treatments are used. This 16-week study examined the feasibility, acceptability, and preliminary efficacy of preloading with nicotine replacement therapy (NRT) in PWH to improve cessation outcomes. METHODS: Forty-nine participants were randomized to nicotine patch preloading (NRT-P) for 3 weeks prior to the target quit date (TQD) or standard treatment with no preloading (ST). All participants received combination NRT for 8 weeks at TQD, with five sessions of behavioral counseling. At week 16, biochemically verified 7-day point-prevalence abstinence was assessed. RESULTS: Mean preloading patch days was 19.7 (out of 21 days; SD 2.7), indicating excellent acceptability. Mean patch days post-TQD (out of 56 days) was 47.4 (SD = 13.2) in NRT-P and 32.7 (SD = 21.8) in ST (t = -2.48, p = .01). At week 16 there was no group difference in week 16 point-prevalence abstinence, but NRT-P participants smoked significantly fewer cigarettes per week (10.1 [SD 14.7] vs. 47.2 [SD 67.6]) and had lower carbon monoxide levels (5.22 [SD 3.6] vs. 10.89 [SD 11.3], p = .04) compared to ST participants. Cessation self-efficacy increased significantly over time in the NRT-P condition only. CONCLUSIONS: NRT preloading is feasible and acceptable among PWH, with excellent adherence to preloading, and benefits observed relative to ST following TQD in patch adherence, self-efficacy, cigarettes smoked per day, and carbon monoxide levels. The lack of effect of preloading on smoking abstinence suggests further study is needed. IMPLICATIONS: Preloading with nicotine patch among PWH who smoke prior to the TQD may be an effective means of improving adherence to smoking cessation medications both pre- and post-quit. By increasing self-efficacy for quitting and lowering cigarette dependence, preloading may improve cessation rates and help reduce the burden of tobacco-related disease among PWH. Further research is needed.