nicotine transdermal / SLA Pharma - LARVOL DELTA

NICOVID: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients (clinicaltrials.gov) - P3; N=220; Recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris; Not yet recruiting ➔ Recruiting; Trial completion date: Jun 2022 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Nicotine: A Targeted Therapy for Epilepsy Due to nAChR Gene Variants. (PubMed, J Child Neurol) - "We propose consideration of transdermal nicotine treatment in intractable epilepsy with known nAChR variants as an experimental therapy. Further clinical trials are needed to fully define therapeutic effects."

Journal • CNS Disorders • Epilepsy

Transdermal Nicotine as a Treatment Option for Ulcerative Colitis: A Review. (PubMed, Cureus) - "These articles were reviewed and analyzed, and it was found that transdermal nicotine in combination with conventional therapy was more beneficial than individual treatment with either. Further controlled studies evaluating the appropriate dosage for remission and maintenance treatment needs to be done."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

NICOVID: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients (clinicaltrials.gov) - P3; N=220; Not yet recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

Design, rationale, and baseline characteristics of a pilot randomized clinical trial of nicotine treatment for pulmonary sarcoidosis. (PubMed, Contemp Clin Trials Commun) - P1/2 | "and Design: This is a randomized double-blind controlled trial of adults with confirmed pulmonary sarcoidosis, allocated in equal proportion to sustained release transdermal nicotine or placebo patch...Nicotine therapy provides promise as a safe, available, and cost-effective intervention strategy, which we expect to be acceptable to patients. NCT02265874."

Clinical • Journal • Diabetes • Fatigue • Fibrosis • Hepatology • Immune Modulation • Immunology • Inflammation • Metabolic Disorders • Osteoporosis • Rheumatology • Sarcoidosis

Effectiveness of transdermal nicotine patch in premenopausal female smokers is moderated by within-subject severity of negative affect and physical symptoms. (PubMed, Psychopharmacology (Berl)) - "Results suggest that among female smokers transdermal nicotine patch effectiveness may interact with negative affect and pain. Understanding and considering female-specific factors that may impact the efficacy of one of the most commonly used cessation medications is important for improving smoking cessation in female smokers."

Clinical • Journal • Pain • Tobacco Cessation

Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine. (PubMed, Am J Prev Med) - P=N/A | "A mandated reduction in the nicotine content of cigarettes is likely to reduce the number of cigarettes smoked per day, but the added benefit of concurrent transdermal nicotine is unclear. Future studies should investigate whether alternative sources of noncombusted tobacco, such as e-cigarettes, enhance the effects of very low nicotine content cigarettes on smoking."

Clinical • Journal

Prolonging the Reduction of Nicotine Self-Administration in Rats by Coadministering Chronic Nicotine With Amitifadine, a Triple Monoamine Reuptake Inhibitor With CYP2B6 Inhibitory Actions. (PubMed, Nicotine Tob Res) - "This study replicated the effects that chronic nicotine or chronic amitifadine, a triple reuptake inhibitor, significantly reduces nicotine self-administration in rats. It extends those findings by showing that the combination of chronic nicotine plus amitifadine causes significantly greater reduction in nicotine self-administration than either drug treatment alone. The combination of chronic amitifadine and chronic nicotine also causes a persistent significant reduction in nicotine self-administration after the end of treatment. The amitifadine and nicotine treatment should be assessed in humans to determine whether this combination provides greater efficacy in smoking cessation than transdermal nicotine treatment alone."

Journal • Preclinical • Tobacco Addiction • Tobacco Cessation

[VIRTUAL] Changes in Pulmonary Function Before and After the Smoking Cessation Therapy (ATS-I 2020) - "RATIONALE To elucidate changes in pulmonary function after the smoking cessation therapy METHODS Data from a prospective registry of a 3-month smoking cessation program comprised of a combination of pharmacological treatment (transdermal nicotine patches or varenicline) and cognitive-behavioral therapy were evaluated. CONCLUSION In our smoking cessation program significant changes in pulmonary function such as FVC, FEV1, and peak expiratory flow were found. Bronchial asthma and baseline FEV1 were predictors of the FEV1 increase."

Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Diabetes • Hypertension • Mental Retardation • Metabolic Disorders • Nicotine Addiction • Oncology • Psychiatry • Respiratory Diseases • Tobacco Addiction • Tobacco Cessation

Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Virginia Commonwealth University; Trial completion date: Jan 2023 ➔ Oct 2022

Trial completion date • Neuralgia • Pain

Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Virginia Commonwealth University; Not yet recruiting ➔ Recruiting

Enrollment open • Neuralgia • Pain

Effects of nicotine on task switching and distraction in non-smokers. An fMRI study. (PubMed, Neuroscience) - "Young healthy non-smokers (n=39) received either a 7 mg transdermal nicotine or placebo patch in a double-blind, within-subject design one hour prior to performing the task in a 3T MR scanner...We suggest that a nicotinic contribution to balancing stability and flexibility is weak in young healthy non-smokers. The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks."

Journal

Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking (clinicaltrials.gov) - P=N/A; N=311; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Recruiting ➔ Active, not recruiting; N=750 ➔ 311

Clinical • Enrollment change • Enrollment closed

Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Virginia Commonwealth University

New P2 trial • Gene Therapies • Neuralgia • Pain

Extended Nicotine Patch Treatment among Smokers With and Without Comorbid Psychopathology. (PubMed, Nicotine Tob Res) - "Abstinence rates for smokers with (22.5%) versus without a psychiatric condition (19.7%) in the 52-week treatment arm did not differ from the 8-week arm. Targeted smoking cessation treatment, rather than extending treatment duration, may be especially warranted to optimize treatment for smokers with comorbid mood, anxiety, and substance use disorders."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • General Anxiety Disorder • Mood Disorders • Substance Abuse • Tobacco Cessation

Differences in the rate of nicotine metabolism among smokers with and without HIV. (PubMed, AIDS) - P3 | "The higher NMR observed among HIV-infected smokers may partially explain higher smoking rates and lower response to transdermal nicotine therapy. Understanding the mechanisms by which HIV and/or ART contribute to faster nicotine metabolism may guide the use of the NMR to personalize tobacco cessation strategies in this underserved population."

Biomarker • Journal • Gene Therapies • Infectious Disease • Tobacco Cessation

Nicotinic treatment of post-chemotherapy subjective cognitive impairment: a pilot study. (PubMed, J Cancer Surviv) - "These results suggest that women with pCRCI can exhibit improvement in subjective cognition, with attention paid to symptoms and close follow-up over a short period of time."

Clinical • Journal • Alzheimer's Disease • Breast Cancer • Gynecologic Cancers • Hematological Disorders • Hematological Malignancies • Oncology • Ovarian Cancer

Evaluation of Heat Effects on Transdermal Nicotine Delivery In Vitro and In Silico Using Heat-Enhanced Transport Model Analysis. (PubMed, AAPS J) - "Model simulations based on data obtained from continuous heat application were able to predict system response to intermittent heat application, as shown by the agreement between the simulation results and experimental data of nicotine fluxes under four different heat application regimens. The combination of in vitro permeation testing and a computational model provided a parameter-based heat and mass transport approach to evaluate heat effects on nicotine TDS delivery."

Journal • Preclinical

Gender differences in the real-world effectiveness of smoking cessation medications: Findings from the 2010-2011 Tobacco Use Supplement to the Current Population Survey. (PubMed, Drug Alcohol Depend) - "Findings for varenicline vs. TNP were consistent with clinical trial data, showing greater differences in effectiveness for women compared to men. Results lend support to the generalizability of clinical trial findings, highlighting the importance of considering gender when offering treatment for smoking cessation."

Journal • Biosimilar

Time controlled pulsatile transdermal delivery of nicotine: A phase I feasibility trial in male smokers. (PubMed) - J Control Release - "Hence, feasibility of controlled pulsatile delivery of nicotine at predetermined intervals was demonstrated. After additional optimization, preprogrammed or on demand administration to meet individualized and circadian replacement needs should improve smoking cessation efficacy."

Journal • Biosimilar

It is feasible and effective to help patients with severe mental disorders to quit smoking: An ecological pragmatic clinical trial with transdermal nicotine patches and varenicline. (PubMed) - Schizophr Res - "Three patients under varenicline had elevated liver enzymes. In conclusion, we have demonstrated that in real-world clinical settings it is feasible and safe to help patients with stabilized severe mental disorders to quit smoking."

Journal • Biosimilar • Depression • Schizophrenia

Smoking Topography Characteristics of Very Low Nicotine Content Cigarettes, with and without Nicotine Replacement, in Smokers with Schizophrenia and Controls. (PubMed) - "Reducing the nicotine in cigarettes to a minimally addictive level has been proposed as a means of reducing tobacco dependence. However, smokers, particularly those with schizophrenia (SS) may alter their puffing in an attempt to extract more nicotine from VLNC cigarettes. This study compared smoking topography of usual brand versus VLNC cigarettes, combined with placebo or transdermal nicotine patches, in SS and controls. Although some changes in topography were indicative of compensatory smoking, total puffs and total cigarette volume were reduced with VLNC cigarettes, indicating that acute VLNC cigarette use does not increase smoking in SS."

Journal • Biosimilar • CNS Disorders • Schizophrenia

Optimization of Carbon Nanotube Membranes by Electrochemical Oxidation for Remotely Programmable Transdermal Nicotine Replacement Therapy (AAPS 2016) - " Electrochemical oxidation is an effective method to open the blocked pores of CNT in order to achieve therapeutically useful nicotine fluxes and also reduce batch to batch variations. These blue-tooth enabled CNT membrane devices along with smart phone app based interventions for behavioral support are highly promising for smoking cessation therapy."

Biosimilar

Acute Nicotine Affects White Matter Integrity of Fronto-Striato-Thalamic Circuits in Non-Smokers (OHBM 2017) - "...On the following day participants received either 7 mg transdermal nicotine or a matched placebo patch in a double-blind, between-subject design 1 hour prior to performing the task...To our knowledge this is the first study to investigate nicotine effects on white matter integrity in healthy non-smokers. In contrast to findings of Kochunov et al (2013) whose cohort consisted of smokers our data point towards reduction of FA values due to acute nicotine administration in healthy non-smokers. This contrast might be due to different tracts of interest but anatomical changes following longterm smoking could also account for the difference."

Clinical • Retrospective data • Attention Deficit Hyperactivity Disorder • Biosimilar • CNS Disorders • Schizophrenia

Varenicline versus Nicotine Patch with Brief Advice for Smokers with Substance Use Disorders with or without Depression: Effects on Smoking, Substance Use and Depressive Symptoms. (PubMed, Addiction) - "Varenicline appears to improve the chances of achieving at least 3 months of smoking abstinence in smokers with substance use disorders trying to stop, compared with transdermal nicotine patches, the effect being independent of history of depressive disorder."

Journal • Biosimilar • CNS Disorders • Depression • Mood Disorders • Psychiatry