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JAMA Internal Medicine Mar 2024Electronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement...
IMPORTANCE
Electronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement therapy (NRT), and no evidence is available on how their efficacy compares with that of varenicline.
OBJECTIVE
To evaluate whether ECs are superior to NRT and noninferior to varenicline in helping smokers quit.
DESIGN, SETTING, AND PARTICIPANTS
This was a randomized clinical trial conducted at 7 sites in China and including participants who were smoking at least 10 cigarettes per day and motivated to quit, not using stop-smoking medications or EC, and willing to use any of the study products. Participants were first recruited in May 2021, and data analysis was conducted in December 2022.
INTERVENTIONS
A cartridge-based EC (30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that), varenicline (0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that), and 2 mg (for smokers of ≤20 cigarettes per day) or 4 mg (>20 cigarettes per day) nicotine chewing gum, all provided for 12 weeks and accompanied by minimal behavioral support (an invitation to join a self-help internet forum).
MAIN OUTCOMES AND MEASURES
The primary outcome was sustained abstinence from smoking at 6 months as validated by an expired-air carbon monoxide reading (<8 parts per million). Participants lost to follow-up were included as nonabstainers.
RESULTS
Of 1068 participants, 357 (33.5%) were female, and the mean (SD) age was 33.9 (3.1) years. A total of 409 (38.3%), 409 (38.3%), and 250 (23.4%) participants were randomized to the EC, varenicline, and NRT arms, respectively. The 6-month biochemically validated abstinence rates were 15.7% (n = 64), 14.2% (n = 58), and 8.8% (n = 22) in the EC, varenicline, and NRT study arms, respectively. The quit rate in the EC arm was noninferior to the varenicline arm (absolute risk reduction, 1.47%; 95% CI, -1.41% to 4.34%) and higher than in the NRT arm (odds ratio, 1.92; 95% CI, 1.15-3.21). Treatment adherence was similar in all study arms during the initial 3 months, but 257 participants (62.8%) in the EC arm were still using ECs at 6 months, with no further use in the 2 other study arms. The most common adverse reactions were throat irritation (32 [7.8%]) and mouth irritation (28 [6.9%]) in the EC arm, nausea (36 [8.8%]) in the varenicline arm, and throat irritation (20 [8.0%]) and mouth irritation (22 [8.8%]) in the NRT arm. No serious adverse events were recorded.
CONCLUSIONS AND RELEVANCE
The results of this randomized clinical trial found that when all treatments were provided with minimal behavior support, the efficacy of EC was noninferior to varenicline and superior to nicotine chewing gum.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR2100048156.
Topics: Female; Humans; Adult; Male; Smoking Cessation; Varenicline; Nicotine Chewing Gum; Electronic Nicotine Delivery Systems; Nicotinic Agonists; Tobacco Use Cessation Devices; Smoking
PubMed: 38285562
DOI: 10.1001/jamainternmed.2023.7846 -
AIDS and Behavior Apr 2024Achieving abstinence from alcohol, tobacco, or both may improve mental health, but is understudied in people with HIV (PWH). The St PETER HIV randomized clinical trial... (Randomized Controlled Trial)
Randomized Controlled Trial
Achieving abstinence from alcohol, tobacco, or both may improve mental health, but is understudied in people with HIV (PWH). The St PETER HIV randomized clinical trial compared varenicline, cytisine, and nicotine replacement therapy on alcohol and smoking behavior among 400 PWH in Russia. The primary exposure was thirty-day point prevalence abstinence (PPA) from (1) alcohol, (2) smoking, (3) both, or (4) neither and was assessed at 1, 3, 6 and 12-months as were the study outcomes of anxiety (GAD-7) and depressive (CES-D) symptoms. The primary aim was to examine the association between smoking and/or alcohol abstinence and subsequent symptoms of depression and anxiety. Primary analysis used repeated measures generalized linear modeling to relate PPA with mental health scores across time. In secondary analyses, Kruskal-Wallis tests related PPA with mental health scores at each timepoint. Primary analyses did not identify significant differences in anxiety or depressive symptoms between exposure groups over time. Secondary analyses found CES-D scores across PPA categories were similar at 1-month (11, 10, 11, 11) and 6-months (10, 10, 11, 11) but differed at 3-months (9, 11, 10, 12; p = 0.035) and 12-months (10, 6, 11, 10; p = 0.019). GAD-7 scores did not vary across PPA categories at any time point. While abstinence was associated with fewer depressive symptoms at times, findings were not consistent during follow-up, perhaps reflecting intermittent relapse. PWH with polysubstance use and mental health comorbidity are complex, and larger samples with sustained abstinence would further elucidate effects of abstinence on mental health.
Topics: Humans; Smoking Cessation; Depression; Tobacco Use Cessation Devices; HIV Infections; Smoking; Varenicline; Ethanol; Anxiety
PubMed: 38285292
DOI: 10.1007/s10461-023-04231-9 -
BMJ Nutrition, Prevention & Health Dec 2023Women seem to have more difficulty quitting smoking than men. This is particularly concerning as smoking puts women at a higher risk of developing smoking-associated...
BACKGROUND
Women seem to have more difficulty quitting smoking than men. This is particularly concerning as smoking puts women at a higher risk of developing smoking-associated diseases. Greater concerns about postcessation weight gain in women have been postulated as a possible explanation.
METHODS
Predefined secondary analysis of a placebo-controlled, double-blind, parallel-group, superiority randomised trial including 255 adults who smoke daily (155 women, 100 men). Participants received weekly dulaglutide (1.5 mg) or placebo (0.9% sodium chloride) in addition to standardised smoking cessation care (varenicline 2 mg/day plus behavioural counselling) over 12 weeks. We aimed to investigate gender differences in weight change after dulaglutide-assisted smoking cessation. Weight change between baseline and week 12 was analysed as absolute and revative weight change and as substantial weight gain (defined as >6% increase).
RESULTS
No gender differences were observed in absolute or relative weight change neither on dulaglutide nor placebo treatment. However, substantial weight gain (defined as >6% increase) in the placebo group was almost five times more frequent in females than males (24% vs 5%). Female patients were less likely to have substantial weight gain on dulaglutide compared with placebo (1% (n=1/83) vs 24% (n=17/72); p<0.001), while this dulaglutide effect was less pronounced in males (0% (n=0/44) vs 5% (n=3/56); p=0.333).
CONCLUSION
Dulaglutide reduced postcessation weight gain in both genders and was very effective in preventing substantial weight gain, which seems to be a specific observation in females.
TRIAL REGISTRATION NUMBER
NCT03204396.
PubMed: 38264360
DOI: 10.1136/bmjnph-2023-000781 -
Journal of Addiction MedicineMethadone and buprenorphine/naloxone (BUP/NX) titration parameters (eg, range, duration, and rate) can vary during opioid use disorder (OUD) treatment. We describe... (Randomized Controlled Trial)
Randomized Controlled Trial
Associations of Methadone and BUP/NX Dose Titration Patterns With Retention in Treatment and Opioid Use in Individuals With Prescription-Type Opioid Use Disorder: Secondary Analysis of the OPTIMA Study.
INTRODUCTION
Methadone and buprenorphine/naloxone (BUP/NX) titration parameters (eg, range, duration, and rate) can vary during opioid use disorder (OUD) treatment. We describe methadone and BUP/NX titration patterns and their associations with treatment outcomes among individuals with a prescription-type OUD.
METHODS
We used data from a 24-week open-label, multicenter randomized controlled trial, including N = 167 participants aged 18-64 years old with prescription-type OUD who received at least a first dose of treatment. Descriptive analyses of methadone and BUP/NX titration patterns were conducted, that is, range and duration from first to maximum dose, and rate (range/duration ratio). Outcomes included percentage of opioid-positive urine drug screens (UDS) and treatment retention. Adjusted linear and logistic regressions were used to study associations between titration patterns and percentage of opioid-positive UDS and treatment retention.
RESULTS
Methadone doses were increased by a mean dose range of 42.4 mg over a mean duration of 42.2 days. BUP/NX doses were increased by a mean dose range of 8.4 mg over a mean duration of 28.7 days. Only methadone dose titration range (odds ratio: 1.03; 95% CI, 1.01 to 1.05) and duration (odds ratio: 1.03; 95% CI, 1.01 to 1.05) were associated with higher retention. Only methadone dose titration rate was associated with lower percentage of opioid-positive UDS at weeks 12-24 ( B : -2.77; 95% CI, -4.72 to -0.81).
CONCLUSIONS
Specific parameters of methadone titration were associated with treatment outcomes and may help in personalizing treatment schedules. Sustained methadone dose titration, when indicated, may help increase retention, whereas faster dose titration for methadone may help decrease opioid use.
Topics: Humans; Adolescent; Young Adult; Adult; Middle Aged; Buprenorphine; Naloxone; Analgesics, Opioid; Methadone; Narcotic Antagonists; Opiate Substitution Treatment; Buprenorphine, Naloxone Drug Combination; Opioid-Related Disorders; Prescriptions
PubMed: 38258865
DOI: 10.1097/ADM.0000000000001267 -
Zhonghua Zhong Liu Za Zhi [Chinese... Jan 2024To evaluate the cost-effectiveness of typical pharmaceutical smoking cessation intervention strategies in China in the context of primary cancer prevention. Markov...
To evaluate the cost-effectiveness of typical pharmaceutical smoking cessation intervention strategies in China in the context of primary cancer prevention. Markov cohort simulation models were established to simulate the burden of 12 smoking caused cancer, including lung cancer, oral cancer, nasopharyngeal cancer, laryngeal cancer, esophageal cancer, gastric cancer, pancreatic cancer, liver cancer, kidney cancer, bladder cancer, cervical cancer, and acute myeloid leukemia. Taking incremental cost effectiveness ratio (ICER) as the main indicator, the model sets one year as the cycling period for 50 periods and simulates the cohort of 10 000 thirty-five-year-old current smokers with various smoking cessation strategies. To ensure the robustness of conclusion, univariate sensitivity analysis, probability sensitivity analysis, and age-group sensitivity analysis were conducted. The results showed that varenicline intervention was the most cost-effective intervention. Compared to the next most effective option, incremental cost of each additional quality-adjusted life year is 11 140.28 yuan, which is below the threshold of willingness to pay (1 year GDP per capita). The value of ICER increased as the increasing age group of adopting intervention, but neither exceeded the threshold of willingness to pay. One-way sensitivity analysis showed that the value of discount rate, the hazard ratio and cost of intervention strategy had a greater impact on the result of ICER. In China, the use of varenicline to quit smoking is highly cost effective in the context of cancer primary prevention, especially for younger smokers.
Topics: Humans; Cost-Benefit Analysis; Smoking Cessation; Cost-Effectiveness Analysis; Nasopharyngeal Neoplasms; Varenicline; China; Kidney Neoplasms; Pharmaceutical Preparations
PubMed: 38246782
DOI: 10.3760/cma.j.cn112152-20231024-00229 -
Toxicology Research Feb 2024Acetamiprid (ACE), is a popular neonicotinoid pesticide, that has a high affinity for mammalian nicotinic acetylcholine receptors (nAChRs). Therefore, ACE might induce...
Acetamiprid (ACE), is a popular neonicotinoid pesticide, that has a high affinity for mammalian nicotinic acetylcholine receptors (nAChRs). Therefore, ACE might induce depressive effects by perturbing the cholinergic system in mammalian. The aim of this study was to evaluate the effects of ACE exposure on depressive-like behaviors and grip strength (GS) in mice. Also the possible role of nAChR activation in depression was assessed by varenicline, and bupropion. Male Swiss mice (27 ± 2 g) were daily exposed to ACE by gavage (0.1, 1, 5 mg/kg), behavioral tests took place after 3 h, 7 days and 15 days, the subacute ACE (0.1 mg/kg) exposure was assessed after 30 days. Varenicline (0.5 mg/kg) or bupropion (4 mg/kg) were injected intraperitoneally 30 min prior exposure to (1 mg/kg) ACE. The locomotor activity, forced swimming test (FST), and sucrose preference (SP) test were assessed. After a week ACE dose dependently increased the immobility time during FST, and after 15 days' depressive behavior was observed equally for ACE (0.1-5 mg/kg). The subacute exposure (0.1 mg/kg) significantly increased the immobility time, SP also declined that revealed anhedonia. These behavioral changes showed that ACE can initiate depressive effects. The changes in locomotor activity were not significant. GS significantly reduced following a week of exposure to ACE (1-5 mg/kg) that indicated neurotoxicity. These effects were antagonized by bupropion or varenicline, thus ACE effect on nAChRs was essential in initiating the depressive behavior.
PubMed: 38239268
DOI: 10.1093/toxres/tfad126 -
The Journal of Physical Chemistry. B Jan 2024According to the pH-partition hypothesis, the aqueous solution adjacent to a membrane is a mixture of the ionization states of the permeating molecule at fixed...
According to the pH-partition hypothesis, the aqueous solution adjacent to a membrane is a mixture of the ionization states of the permeating molecule at fixed Henderson-Hasselbalch concentrations, such that each state passes through the membrane in parallel with its own specific permeability. An alternative view, based on the assumption that the rate of switching ionization states is instantaneous, represents the permeation of ionizable molecules via an effective Boltzmann-weighted average potential (BWAP). Such an assumption is used in constant-pH molecular dynamics simulations. The inhomogeneous solubility-diffusion framework can be used to compute the pH-dependent membrane permeability for each of these two limiting treatments. With biased WTM-eABF molecular dynamics simulations, we computed the potential of mean force and diffusivity of each ionization state of two weakly basic small molecules: nicotine, an addictive drug, and varenicline, a therapeutic for treating nicotine addiction. At pH = 7, the BWAP effective permeability is greater than that determined by pH-partitioning by a factor of 2.5 for nicotine and 5 for varenicline. To assess the importance of ionization kinetics, we present a Smoluchowski master equation that includes explicitly the protonation and deprotonation processes coupled with the diffusive motion across the membrane. At pH = 7, the increase in permeability due to the explicit ionization kinetics is negligible for both nicotine and varenicline. This finding is reaffirmed by combined Brownian dynamics and Markov state model simulations for estimating the permeability of nicotine while allowing changes in its ionization state. We conclude that for these molecules the pH-partition hypothesis correctly captures the physics of the permeation process. The small free energy barriers for the permeation of nicotine and varenicline in their deprotonated neutral forms play a crucial role in establishing the validity of the pH-partitioning mechanism. Essentially, BWAP fails because ionization kinetics are too slow on the time scale of membrane crossing to affect the permeation of small ionizable molecules such as nicotine and varenicline. For the singly protonated state of nicotine, the computational results agree well with experimental measurements ( = 1.29 × 10 cm/s), but the agreement for neutral ( = 6.12 cm/s) and doubly protonated nicotine ( = 3.70 × 10 cm/s) is slightly worse, likely due to factors associated with the aqueous boundary layer (neutral form) or leaks through paracellular pathways (doubly protonated form).
Topics: Nicotine; Varenicline; Membranes; Cell Membrane Permeability; Permeability; Physics; Hydrogen-Ion Concentration; Kinetics
PubMed: 38227958
DOI: 10.1021/acs.jpcb.3c06765 -
American Family Physician Jan 2024Excessive alcohol use is a leading cause of preventable death in the United States, with alcohol-related deaths increasing during the pandemic. The Substance Abuse and...
Excessive alcohol use is a leading cause of preventable death in the United States, with alcohol-related deaths increasing during the pandemic. The Substance Abuse and Mental Health Services Administration recommends that physicians offer pharmacotherapy with behavioral interventions for patients diagnosed with alcohol use disorder. Several medications are available to help patients reduce drinking and maintain abstinence; however, in 2019, only 7.3% of Americans with alcohol use disorder received any treatment, and only 1.6% were prescribed medications to treat the disorder. Strong evidence shows that naltrexone and gabapentin reduce heavy-drinking days and that acamprosate prevents return-to-use in patients who are currently abstinent; moderate evidence supports the use of topiramate in decreasing heavy-drinking days. Disulfiram has been commonly prescribed, but little evidence supports its effectiveness outside of supervised settings. Other medications, including varenicline and baclofen, may be beneficial in reducing heavy alcohol use. Antidepressants do not decrease alcohol use in patients who do not have mood disorders, but they may help patients who meet criteria for depression to decrease their alcohol intake. Systematic policies are needed to expand the use of medications when treating alcohol use disorder in inpatient and outpatient populations.
Topics: Humans; Alcoholism; Alcohol Deterrents; Acamprosate; Alcohol Drinking; Naltrexone; Disulfiram
PubMed: 38227873
DOI: No ID Found -
Nicotine & Tobacco Research : Official... Jun 2024This study aimed to (1) provide up-to-date estimates of how changes in the prevalence of e-cigarette use have been associated with changes in smoking cessation...
Associations of Prevalence of E-cigarette Use With Quit Attempts, Quit Success, Use of Smoking Cessation Medication, and the Overall Quit Rate Among Smokers in England: A Time-Series Analysis of Population Trends 2007-2022.
INTRODUCTION
This study aimed to (1) provide up-to-date estimates of how changes in the prevalence of e-cigarette use have been associated with changes in smoking cessation activities and use of licensed treatments among smokers in England and (2) explore any changes in these associations over time.
METHODS
Data were aggregated quarterly on 67 548 past-year smokers between Q1-2007 and Q4-2022. Explanatory variables were the prevalence of (1) current e-cigarette use among smokers and (2) e-cigarette use during a quit attempt. Outcomes were rates of quit attempts and overall quits among past-year smokers, and the quit success rate and use of licensed treatments among those who made a quit attempt.
RESULTS
The success rate of quit attempts increased by 0.040% (95% CI 0.019; 0.062) for every 1% increase in the prevalence of e-cigarette use during a quit attempt. No clear evidence was found for an association between current e-cigarette use and the quit attempt rate (Badj = 0.008 [95% CI -0.045; 0.061]) or overall quit rate (Badj = 0.063 [-0.031; 0.158]); or between use of e-cigarettes during a quit attempt and the overall quit rate (Badj = 0.030 [-0.054; 0.114]), use of prescription medication (varenicline/bupropion/nicotine replacement therapy [NRT]: Badj = -0.036 [-0.175; 0.102]), or use of over-the-counter NRT (Badj = -0.052 [-0.120; 0.015]). There was no clear evidence this pattern of associations has changed substantially over time.
CONCLUSIONS
Changes in the prevalence of e-cigarette use in England through 2022 have been positively associated with the success rate of quit attempts but not clearly associated with the quit attempt rate, overall quit rate, or use of licensed smoking cessation treatments.
IMPLICATIONS
If the association between the increase in e-cigarette use and the quit success rate is causal, then the use of e-cigarettes in quit attempts has helped in the region of 30 000 to 50 000 additional smokers in England to successfully quit each year since they became popular in 2013, over and above the number who were quitting before the advent of e-cigarettes.
Topics: Humans; Smoking Cessation; England; Electronic Nicotine Delivery Systems; Female; Male; Adult; Prevalence; Middle Aged; Vaping; Smokers; Young Adult; Smoking Cessation Agents; Adolescent; Tobacco Use Cessation Devices; Aged
PubMed: 38214664
DOI: 10.1093/ntr/ntae007 -
The Medical Letter on Drugs and... Jan 2024
Topics: Humans; Dry Eye Syndromes; Cyclosporine; Ophthalmic Solutions; Fluorocarbons
PubMed: 38212258
DOI: 10.58347/tml.2024.1694c