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INTRODUCTION: Varenicline helps people who smoke quit at rates 2-3 times greater than placebo. Currently in the U.S., varenicline is not available over the counter (OTC). In this study, we assessed the safety and efficacy of 1mg and 0.5mg varenicline as an OTC medication for smoking cessation in comparison to placebo. METHODS: This randomized, double-blind, placebo-controlled study was performed at two clinical sites in the United States of n=313 people. The treatment period was 12 weeks. During the COVID pandemic, the protocol was modified to allow remote participation; verification of smoking status was via breath carbon monoxide levels for in-person visits and mailed urine cotinine kits for the remote participants. RESULTS: There was no difference in biologically confirmed continuous abstinence by condition between Weeks 8-12; however, the odds of biologically confirmed point prevalence abstinence were higher for those in the 1mg b.i.d. condition than for those in the placebo condition at Week 12 (OR 3.39; 95% CI 1.49, 7.71), and were higher for those assigned to the 1.0mg b.i.d. condition than the 0.5mg b.i.d. condition at Week 12 (OR 2.37; 95% CI 1.11, 5.05). Adverse events were modest, and as expected (vivid dreams and nausea in the medication conditions). CONCLUSIONS: The results are suggestive that varenicline is safe and effective as an OTC medication.

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BACKGROUND AND AIM: During post-amputation recovery or rapid body mass change, residual limb volume can change quickly, requiring frequent adjustments or replacement of the socket to maintain fit. The aim of this pilot test was to evaluate the feasibility of using a three-dimensional-printed insert to extend the service life of a prosthetic socket after substantial residual limb volume loss. TECHNIQUE: One research subject with a well-fitting transtibial prosthetic socket had an oversized socket fabricated to simulate substantial limb volume loss. The digital shapes of the oversized and well-fitting sockets were used to create a three-dimensional-printed insert to restore fit. DISCUSSION: Two-minute walk test distance decreased when using the oversized socket without the insert, but not when using the socket with the insert. Socket comfort score was 8+ under all conditions. These results suggest that three-dimensional-printed inserts may be an effective method of extending the service life of prosthetic sockets when rapid limb volume loss occurs. CLINICAL RELEVANCE: Three-dimensional (3D) printing gives prosthetists a new tool to manage large volume changes without refabricating entire sockets. Sockets can be fabricated in anticipation of volume gain/loss, using replaceable 3D-printed inserts to maintain fit and comfort.

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Peripheral neuropathy may cause loss of sensory information from plantar cutaneous mechanoreceptors that is important for balance control and falls management. The current study investigated short-term effects of using Walkasins, an external lower-limb sensory neuroprosthesis, on clinical outcomes of balance and gait in persons who reported peripheral neuropathy and balance problems. The device replaces lost plantar sensation with tactile balance information that modulates cutaneous mechanoreceptors above the ankle where sensation is intact. Thirty-one male community-dwelling Veterans, 56-84 years old with insensate feet and balance problems participated. Initial Functional Gait Assessment, gait speed, and 4-Stage Balance Test outcomes were assessed. After initial assessment, subjects were randomly assigned to either wearing Walkasins turned ON, or OFF, and outcomes were re-assessed following a set of standardized balance exercises. Following a one-hour rest and washout period, treatments were crossed-over between groups and a third outcomes assessment was performed. Before cross-over, 10 of 15 subjects in the ON-then-OFF group improved their Functional Gait Assessment score by at least four points, the Minimal Clinically Important Difference, compared to 5 of 16 in the OFF-then-ON group. After cross-over, 7 of 16 subjects in the OFF-then-ON group improved by at least four points versus 2 of 15 in the ON-then-OFF group. ON treatment was associated with a Functional Gait Assessment improvement of 4.4 ± 3.7 points versus 1.5 ± 1.2 for the OFF treatment (p<0.01). Overall, Functional Gait Assessment scores changed from 15.2 ± 4.8 at initial assessment to 21.1 ± 5.2 after final assessment (p<0.001). At the end of the two treatment sessions, 16 of the 31 individuals had improved their Functional Gait Assessment score beyond 23, indicating normal fall-risk status. Future studies should investigate long-term benefits of the device to reduce fall risk and actual falls in patients with peripheral neuropathy and balance problems.

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