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Brain Stimulation 2023
Topics: Varenicline; Transcranial Direct Current Stimulation; Smoking; Smoking Cessation
PubMed: 37406928
DOI: 10.1016/j.brs.2023.07.001 -
Health Psychology Research 2023Bupropion had been in use since the late 1980s as an unconventional treatment for depression. Unlike other antidepressants, bupropion has no serotonergic activity and...
Bupropion had been in use since the late 1980s as an unconventional treatment for depression. Unlike other antidepressants, bupropion has no serotonergic activity and inhibits the reuptake of norepinephrine and dopamine. The drug has been used to treat depression, Attention Deficit Hyperactivity Disorder (ADHD), and smoking cessation. This investigation reviews the pharmacokinetic and pharmacodynamic effects of bupropion and its mechanisms of action and interactions with other drugs. We evaluated the efficacy of major on and off-label uses of bupropion, focusing on the indications, benefits, and adverse effects. Our review demonstrates that bupropion is superior to placebo and non-inferior to SSRIs such as escitalopram in treating major depressive disorder. More research is needed to determine positive patient-centered outcomes such as increases in quality of life. In the case of ADHD, the evidence for efficacy is mixed with poorly conducted randomized clinical trials, small sample sizes, and a lack of long-term assessments. The same is true in the case of bipolar disorder in which there is still limited and controversial data available on bupropion's safety and efficacy. In the case of smoking cessation, bupropion is found to be an effective anti-smoking drug with synergistic benefits when used as a combination therapy. We conclude that bupropion has the potential to provide benefit for a subset of patients who do not tolerate other typical antidepressants or anti-smoking therapies or for those whose treatment goals align with bupropion's unique side effect profile, such as smokers who wish to quit and lose weight. Additional research is needed to determine the drug's full clinical potential, particularly in the areas of adolescent depression and combination therapy with varenicline or dextromethorphan. Clinicians should use this review to understand the varied uses of the drug and identify the situations and patient populations in which bupropion can lend its greatest benefit.
PubMed: 37405312
DOI: 10.52965/001c.81043 -
BMC Medicine Jul 2023Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping.
METHODS
Design: Double-blind, randomized, parallel-group, placebo-controlled trial.
SETTING
The study took place at a University-run smoking cessation center.
PARTICIPANTS
People who exclusively use ECs daily and intend to quit vaping.
INTERVENTION
A total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase.
MAIN OUTCOMES AND MEASURES
The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24.
RESULTS
CAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25-5.68], P = 0.011); weeks 4-24, 34.3% for varenicline with counseling and 17.2% for placebo with counseling (OR = 2.52, 95% CI = [1.14-5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related.
CONCLUSIONS
The findings of the present RCT indicate that inclusion of varenicline in a vaping cessation program for people who use electronic cigarettes and intending to quit may result in prolonged abstinence. These positive findings establish a benchmark of intervention effectiveness, may support the use of varenicline combined with counseling in vaping cessation programs, and may also help guiding future recommendations by health authorities and healthcare providers.
TRIAL REGISTRATION
The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42.
Topics: Humans; Varenicline; Nicotinic Agonists; Vaping; Electronic Nicotine Delivery Systems; Benzazepines; Quinoxalines; Double-Blind Method; Counseling; Treatment Outcome
PubMed: 37403047
DOI: 10.1186/s12916-023-02919-2 -
Indian Journal of Psychiatry May 2023According to the Global Burden of Disease (GBD) Study conducted in 2019, smoking tobacco leads to over 8 million deaths each year. Hence, it is crucial to identify... (Review)
Review
According to the Global Burden of Disease (GBD) Study conducted in 2019, smoking tobacco leads to over 8 million deaths each year. Hence, it is crucial to identify optimal smoking cessation therapy. To compare the efficacy of varenicline versus bupropion for smoking cessation by performing a meta-analysis of randomized controlled trials (RCTs). Protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO). The Patient intervention comparison outcome time (PICOT) format is used in the study. Patients having nicotine use disorder treated with varenicline or bupropion were included, and the continuous abstinence rate (CAR) was assessed at 12, 24, and 52 weeks. The PubMed and Google Scholar databases were systematically searched, and after the screening, RCTs involving a comparison of varenicline and bupropion in smoking cessation were included. We performed a meta-analysis of three RCTs (10110 patients) by RevMan 5.4.1 statistical software to determine the efficacy of varenicline compared with bupropion in smoking cessation. The CAR at 9- to 12-week follow-up of varenicline is superior to bupropion (OR = 1.79, CI range: 1.59-2.02, < 0.001). Similarly, the CAR of varenicline is superior to bupropion for weeks 9-24 (1.51, 1.32 to 1.72) and weeks 9-52 (1.60, 1.22 to 2.12), suggesting the absolute advantage of varenicline over bupropion for smoking cessation in terms of efficacy. Both varenicline and bupropion are efficacious therapies for smoking cessation. Compared with bupropion, varenicline can significantly improve the CAR at the end of treatment, at 24 weeks, and at 52 weeks of follow-up.
PubMed: 37397838
DOI: 10.4103/indianjpsychiatry.indianjpsychiatry_218_22 -
JAMA Psychiatry Sep 2023Tobacco smoking drives markedly elevated cardiovascular disease risk and preventable death in persons with serious mental illness, and these risks are compounded by the... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Tobacco smoking drives markedly elevated cardiovascular disease risk and preventable death in persons with serious mental illness, and these risks are compounded by the high prevalence of overweight/obesity that smoking cessation can exacerbate. Guideline-concordant combined pharmacotherapy and behavioral smoking cessation treatment improves abstinence but is not routinely offered in community settings, particularly to those not seeking to quit smoking immediately.
OBJECTIVE
To determine the effectiveness of an 18-month pharmacotherapy and behavioral smoking cessation intervention incorporating weight management and support for physical activity in adults with serious mental illness interested in quitting smoking within 1 or 6 months.
DESIGN, SETTING, AND PARTICIPANTS
This was a randomized clinical trial conducted from July 25, 2016, to March 20, 2020, at 4 community health programs. Adults with serious mental illness who smoked tobacco daily were included in the study. Participants were randomly assigned to intervention or control, stratified by willingness to try to quit immediately (within 1 month) or within 6 months. Assessors were masked to group assignment.
INTERVENTIONS
Pharmacotherapy, primarily varenicline, dual-form nicotine replacement, or their combination; tailored individual and group counseling for motivational enhancement; smoking cessation and relapse prevention; weight management counseling; and support for physical activity. Controls received quitline referrals.
MAIN OUTCOME AND MEASURES
The primary outcome was biochemically validated, 7-day point-prevalence tobacco abstinence at 18 months.
RESULTS
Of the 298 individuals screened for study inclusion, 192 enrolled (mean [SD] age, 49.6 [11.7] years; 97 women [50.5%]) and were randomly assigned to intervention (97 [50.5%]) or control (95 [49.5%]) groups. Participants self-identified with the following race and ethnicity categories: 93 Black or African American (48.4%), 6 Hispanic or Latino (3.1%), 90 White (46.9%), and 9 other (4.7%). A total of 82 participants (42.7%) had a schizophrenia spectrum disorder, 62 (32.3%) had bipolar disorder, and 48 (25.0%) had major depressive disorder; 119 participants (62%) reported interest in quitting immediately (within 1 month). Primary outcome data were collected in 183 participants (95.3%). At 18 months, 26.4% of participants (observed count, 27 of 97 [27.8%]) in the intervention group and 5.7% of participants (observed count, 6 of 95 [6.3%]) in the control group achieved abstinence (adjusted odds ratio [OR], 5.9; 95% CI, 2.3-15.4; P < .001). Readiness to quit within 1 month did not statistically significantly modify the intervention's effect on abstinence. The intervention group did not have significantly greater weight gain than the control group (mean weight change difference, 1.6 kg; 95% CI, -1.5 to 4.7 kg).
CONCLUSIONS AND RELEVANCE
Findings of this randomized clinical trial showed that in persons with serious mental illness who are interested in quitting smoking within 6 months, an 18-month intervention with first-line pharmacotherapy and tailored behavioral support for smoking cessation and weight management increased tobacco abstinence without significant weight gain.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02424188.
Topics: Adult; Humans; Female; Middle Aged; Tobacco Use Cessation; Smoking Cessation; Depressive Disorder, Major; Tobacco Use Cessation Devices; Weight Gain
PubMed: 37378972
DOI: 10.1001/jamapsychiatry.2023.1691 -
Digital Health 2023Varenicline is the most efficacious approved smoking cessation medication, making it one of the most cost-effective clinical interventions for reducing tobacco-related...
OBJECTIVE
Varenicline is the most efficacious approved smoking cessation medication, making it one of the most cost-effective clinical interventions for reducing tobacco-related morbidity and mortality. Adhering to varenicline is strongly associated with smoking cessation. Healthbots have the potential to help people adhere to their medications by scaling up evidence-based behavioral interventions. In this protocol, we outline how we will follow the UK's Medical Research Council's guidance to codesign a theory-informed, evidence-based, and patient-centered healthbot to help people adhere to varenicline.
METHODS
The study will utilize the Discover, Design and Build, and Test framework and will include three phases: (a) a rapid review and interviews with 20 patients and 20 healthcare providers to understand barriers and facilitators to varenicline adherence (Discover phase); (b) Wizard of Oz test to design the healthbot and get a sense of the questions that chatbot has to be able to answer (Design phase); and (c) building, training, and beta-testing the healthbot (Building and Testing phases) where the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability framework will be used to develop the healthbot using the simplest sensible solution, and 20 participants will beta test the healthbot. We will use the Capability, Opportunity, Motivation-Behavior (COM-B) model of behavior change and its associated framework, the Theoretical Domains Framework, to organize the findings.
CONCLUSIONS
The present approach will enable us to systematically identify the most appropriate features for the healthbot based on a well-established behavioral theory, the latest scientific evidence, and end users' and healthcare providers' knowledge.
PubMed: 37377562
DOI: 10.1177/20552076231182807 -
Journal of Personalized Medicine May 2023There has been a worldwide substantial increase in accidental opioid-overdose deaths. The aim of this review, along with preliminary results from our pilot study, is to...
There has been a worldwide substantial increase in accidental opioid-overdose deaths. The aim of this review, along with preliminary results from our pilot study, is to highlight the use of pharmacogenetics as a tool to predict causes of accidental opioid-overdose death. For this review, a systematic literature search of PubMed between the time period of January 2000 to March 2023 was carried out. We included study cohorts, case-controls, or case reports that investigated the frequency of genetic variants in opioid-related post-mortem samples and the association between these variants and opioid plasma concentrations. A total of 18 studies were included in our systematic review. The systematic review provides evidence of the use of , and to a lower extent, and genotyping in identifying unexpectedly high or low opioid and metabolite blood concentrations from post-mortem samples. Our own pilot study provides support for an enrichment of the *4-allele in our methadone-overdose sample ( = 41) compared to the anticipated frequency in the general population. The results from our systematic review and the pilot study highlight the potential of pharmacogenetics in determining vulnerability to overdose of opioids.
PubMed: 37373907
DOI: 10.3390/jpm13060918 -
Psychiatria Polska May 2023The development of treatment methods for nicotine dependence has progressed slowly because people with psychiatric disorders are usually excluded from participating in...
The development of treatment methods for nicotine dependence has progressed slowly because people with psychiatric disorders are usually excluded from participating in clinical trials. There are several therapeutic options to support smoking cessation, including psychological and pharmacological interventions, which should be offered to smokers with mental disorders. The first step in helping tobacco smokers and nicotine-dependent individuals is the assessment of smoking intensity and confirmation of nicotine dependence. Currently, we have several methods of treating nicotine dependence - starting from education and psychotherapy, through pharmacotherapy and replacement therapy, and ending up with obtaining gradual progress with the application of harm reduction. Pharmacological treatment options include nicotine replacement therapy, varenicline or bupropion. The effectiveness of such interventions can be improved by providing anti-smoking therapy under psychiatric treatment and promoting harm reduction as an acceptable initial therapeutic goal. The harm reduction strategy is an approach that should be taken into account individually, particularly in the case of individuals unable to stop smoking, patients with limited insight into their illness, patients experiencing an exacerbation of their illness and persistently uncooperative patients. In this paper, recommendations of the Polish Psychiatric Association on the diagnostics and different treatment methods for nicotine dependence in patients with psychiatric disorders are presented.
PubMed: 37370219
DOI: 10.12740/PP/OnlineFirst/161774 -
JMIR Formative Research Jun 2023Smoking remains a major public health problem, and it is important to provide a variety of efficacious and appealing options to encourage smokers to quit smoking....
BACKGROUND
Smoking remains a major public health problem, and it is important to provide a variety of efficacious and appealing options to encourage smokers to quit smoking. Scheduled smoking is a method of gradual reduction, preparing smokers to quit by systematically reducing cigarette consumption according to a predetermined schedule that increases the time between cigarette consumption. Gradual reduction may be preferred to abrupt quitting, but the efficacy of this cessation approach is unclear.
OBJECTIVE
This study aims, first, to evaluate the overall effectiveness of scheduled smoking alone, or in combination with precessation nicotine replacement therapy (NRT), versus standard NRT starting on the quit date with no prior smoking reduction and, second, to evaluate the impact of schedule compliance on the effectiveness of the intervention.
METHODS
A total of 916 participants recruited from the Houston metropolitan area were randomly assigned to 1 of the following 3 groups: scheduled smoking plus a precessation nicotine patch (n=306, 33.4%), scheduled smoking only with no precessation patch (n=309, 33.7%), and enhanced usual care (n=301, 32.9%) control. The primary abstinence outcomes were carbon monoxide-verified, self-reported, 7-day point prevalence abstinence at 2 and 4 weeks after the quit date. Unadjusted and adjusted logistic regression analyses were performed to evaluate the intervention effect. Scheduled smoking was implemented using a handheld device for 3 weeks before quitting. This trial was not registered because data collection began before July 1, 2005.
RESULTS
Results for the first aim showed no overall differences in abstinence among the 3 groups in both the unadjusted and adjusted models. However, the results for the second aim showed a clear effect on abstinence by schedule compliance at 2 and 4 weeks and 6 months after quitting (odds ratio [OR] 2.01, 95% CI 1.31-3.07), 4 weeks (OR 1.58, 95% CI 1.05-2.38), and 6 months (OR 1.68, 95% CI 1.04-2.64), with the differences at 2 and 4 weeks after quitting being the most robust. We also found that scheduled smoking was related to a reduction in nicotine withdrawal, negative affect, and craving when compared with the controls.
CONCLUSIONS
Scheduled smoking, when combined with precessation use of NRT, can result in significantly higher abstinence rates than usual care (abrupt quitting with NRT), particularly in the early postquit phase (2 and 4 weeks after cessation) when smokers are compliant with the procedure. Scheduled smoking also produced a better overall quitting experience by reducing symptoms of nicotine withdrawal and craving, in comparison with usual care, which could encourage future quit attempts. Studies in this area should focus on the use of counseling or other methods to improve adherence.
PubMed: 37338956
DOI: 10.2196/39487 -
JAMA Network Open Jun 2023Adapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Adapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic minority individuals who smoke and tend to have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality.
OBJECTIVE
To evaluate efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC) included non-Hispanic Black adults who smoke and was conducted from May 2019 to January 2022 at a federally qualified health center in Kansas City, Missouri. Data analysis took place from March 2022 to January 2023.
INTERVENTIONS
Both groups received 18 weeks of pharmacotherapy with long-term follow-up through week 26. The ADT group consisted of 196 individuals who received a nicotine patch (NP) and up to 2 pharmacotherapy adaptations, with a first switch to varenicline at week 2 and, if needed, a second switch to bupropion plus NP (bupropion + NP) based on carbon monoxide (CO)-verified smoking status (CO ≥6 ppm) at week 6. The UC group consisted of 196 individuals who received NP throughout the duration of treatment.
MAIN OUTCOMES AND MEASURES
Anabasine-verified and anatabine-verified point-prevalence abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points). The χ2 test was used to compare verified abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points) between ADT and UC. A post hoc sensitivity analysis of smoking abstinence at week 12 was performed with multiple imputation using a monotone logistic regression with treatment and gender as covariates to impute the missing data.
RESULTS
Among 392 participants who were enrolled (mean [SD] age, 53 [11.6] years; 224 [57%] female; 186 [47%] ≤ 100% federal poverty level; mean [SD] 13 [12.4] cigarettes per day), 324 (83%) completed the trial. Overall, 196 individuals were randomized to each study group. Using intent-to-treat and imputing missing data as participants who smoke, verified 7-day abstinence was not significantly different by treatment group at 12 weeks (ADT: 34 of 196 [17.4%]; UC: 23 of 196 [11.7%]; odds ratio [OR], 1.58; 95% CI, 0.89-2.80; P = .12), 18 weeks (ADT: 32 of 196 [16.3%]; UC: 31 of 196 [15.8%]; OR, 1.04; 95% CI, 0.61-1.78; P = .89), and 26 weeks (ADT: 24 of 196 [12.2%]; UC: 26 of 196 [13.3%]; OR, 0.91; 95% CI, 0.50-1.65; P = .76). Of the ADT participants who received pharmacotherapy adaptations (135/188 [71.8%]), 11 of 135 (8.1%) were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had CO-verified abstinence at week 2 had 4.6 times greater odds of being abstinent at week 12 (37 of 129 [28.7%] abstinence) than those who did not respond to treatment (19 of 245 [7.8%] abstinence; OR; 4.6; 95% CI, 2.5-8.6; P < .001).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial of adapted vs standard of care pharmacotherapy, adaptation to varenicline and/or bupropion + NP after failure of NP monotherapy did not significantly improve abstinence rates for Black adults who smoke relative to those who continued treatment with NP. Those who achieved abstinence in the first 2 weeks of the study were significantly more likely to achieve later abstinence, highlighting early treatment response as an important area for preemptive intervention.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03897439.
Topics: Adult; Humans; Female; Middle Aged; Male; Smoking Cessation; Varenicline; Bupropion; Ethnicity; Minority Groups; Nicotine; Smoking
PubMed: 37338906
DOI: 10.1001/jamanetworkopen.2023.17895