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Biomedical subjects

Peter Hajek

Publications and source records attributed to Peter Hajek.

15 recordsLinked to original sources
PubMed2007

Dependence potential of nicotine replacement treatments: effects of product type, patient characteristics, and cost to user.

OBJECTIVE: To assess the extent of long-term use of different nicotine replacement treatment products in smokers attending routine smoking cessation treatment and to examine the effect of nicotine replacement treatment cost on its long-term use. METHOD: 1518 consecutive patients prescribed nicotine replacement treatment at the East London Smokers' Clinic between January 2000 and November 2002 were followed up at 1-year. RESULTS: The rates of long-term use ranged from 2% for patch to 13% for nasal spray. Long-term use of nicotine replacement treatment was significantly more likely in more dependent smokers. Treatment cost, and whether it was provided free of charge, had no significant effect on its long-term use. CONCLUSIONS: Long-term use of nicotine replacement treatment is not uncommon. Its occurrence seems positively related to speed of nicotine delivery of individual products. For self-selected highly dependent smokers, long-term use of nicotine replacement treatment may be a necessary precondition for maintaining long-term abstinence. The findings have financial and clinical implications for providers of smoking cessation services.

Administration, Cutaneous↗
PubMed2006

Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial.

CONTEXT: The majority of cigarette smokers who achieve abstinence relapse within the first year and require many attempts before achieving permanent abstinence. Evidence to support pharmacological treatment for relapse prevention is insufficient. OBJECTIVE: To determine whether smokers who quit after 12 weeks of treatment with varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, maintain greater continuous abstinence rates (defined as not a single "puff" of a cigarette) than placebo controls during an additional 12 weeks of treatment and until 52 weeks after treatment initiation. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted at multiple medical clinics in 7 countries with follow-up to 52 weeks after study baseline. Of 1927 cigarette smokers recruited between April 2003 and February 2004 and treated for 12 weeks with open-label varenicline titrated to 1 mg twice per day, 1236 (64.1%) did not smoke, use tobacco, or use nicotine replacement therapy during the last week of treatment and 62.8% (n = 1210) were randomized to additional treatment or placebo. INTERVENTION: Participants were randomly assigned to receive either double-blind varenicline, 1 mg twice per day (n = 603), or placebo (n = 607) for an additional 12 weeks. MAIN OUTCOME MEASURES: Carbon monoxide-confirmed continued abstinence during weeks 13 to 24 and weeks 13 to 52 of the study. RESULTS: The carbon monoxide-confirmed continuous abstinence rate was significantly higher for the varenicline group than for the placebo group for weeks 13 to 24 (70.5% vs 49.6%; odds ratio [OR], 2.48; 95% confidence interval [CI], 1.95-3.16; P<.001) as well as for weeks 13 to 52 (43.6% vs 36.9%; OR, 1.34; 95% CI, 1.06-1.69; P = .02). Adverse events reported in the open-label period were mostly mild; no difference in adverse events between varenicline and placebo was observed during the double-blind period. CONCLUSIONS: Smokers who achieved abstinence for at least 7 days at the end of 12 weeks of open-label varenicline treatment and were randomized to receive an additional 12 weeks of varenicline treatment showed significantly greater continuous abstinence in weeks 13 to 24 compared with placebo. This advantage was maintained through the nontreatment follow-up to week 52. Varenicline may be an efficacious, safe, and well-tolerated agent for maintaining abstinence from smoking. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00143286.

Adult↗
PubMed2006

Prevention of relapse after quitting smoking: a systematic review of trials.

BACKGROUND: After initially successful quit attempts, many people return to smoking within a year, reducing the public health benefits of investment in smoking cessation. We aimed to assess whether interventions designed to prevent relapse after a successful quit attempt reduce the proportion of recent quitters who return to smoking. METHODS: We searched the Cochrane Tobacco Addiction Review Group trials' register. We selected randomized or quasi-randomized controlled trials of relapse prevention interventions with a minimum follow-up of 6 months. We included people who quit on their own, underwent enforced abstinence, or were in treatment programs. We included trials comparing relapse prevention interventions with no intervention or cessation plus relapse prevention with cessation intervention alone. Two of us independently extracted data from each report, with disagreements referred to a third author. RESULTS: Forty-two studies met the inclusion criteria. The most common interventions were skills training to identify and resolve tempting situations and extended treatment contact. A few studies tested pharmacotherapy. We separately analyzed studies that randomized abstainers and those that randomized participants before their quit date. Within subgroups of trials, pooled odds ratios ranged from 0.86 to 1.30, and in most analyses, 95% confidence intervals included 1. Most studies had limited power to detect moderate differences between interventions. CONCLUSION: The evidence to date does not support the adoption of skills training or other specific interventions to help individuals who have successfully quit smoking to avoid relapse, but this is an important area for future study.

Clinical Trials as Topic↗
PubMed2006

Randomized controlled trial of a social support ('buddy') intervention for smoking cessation.

OBJECTIVE: To assess the effectiveness of including a social support intervention ('buddy system') in a group treatment programme to aid smoking cessation. METHODS: Five hundred and sixty-three smokers attended groups at a smokers' clinic. These groups were randomized either to be (a) groups in which smokers were paired with another person to provide mutual support (buddy condition: n=237 in 14 groups) or (b) to receive the same treatment without the buddy component (control: n=326 in 20 groups). Participants were seen weekly for the first 4 weeks after stopping then followed up again after 26 weeks. RESULTS: Smokers in the buddy condition were no more likely than smokers in the control condition to stay abstinent at 1, 4 or 26 weeks. The effect was in the right direction at week one post-quit but after controlling for potential confounders the difference was not significant (odds ratio=1.45 (95% CI; 0.92-2.29), p=0.06). CONCLUSIONS: We were unable to show that a buddy system improved abstinence rates of group treatment programmes. This might be due to the high level of social support already achieved through the groups. PRACTICE IMPLICATIONS: The buddy system is a simple and very low cost addition to a group treatment programme; but the results from this study suggest that the kind of buddy system tested may not add substantially to the success rates. However there may be merits in a more intensive or protracted form of buddying.

Adult↗
PubMed2006

Best practice in smoking cessation services for pregnant women: results of a survey of three services reporting the highest national returns, and three beacon services.

AIMS: The NHS allocated dedicated funds to establish specialist smoking cessation services for pregnant smokers in England in 2000. An early survey revealed some uncertainty as to how the new services should work and monitor their outcome. The current survey focused on identifying examples of good practice in this difficult new field. METHOD: Three services with the highest number of successful four-week quitters reported for the 2003/4 monitoring year were identified from Department of Health (DH) monitoring records, and three services were nominated from those known in the field as examples of best practice. There was no overlap between the two groups. All six services provided in-depth interviews. RESULTS: All three highest ranking services that reported close to 100 per cent success rates included unaided quitters identified from hospital wards, rather then smokers actually treated. They had only minimal or average genuine treatment provision for pregnant smokers in place. The three beacon services far exceeded the national throughput and outcome average identified in the previous survey, and provided a wealth of useful information. Although they differed in staffing levels and other aspects of their activities, they all shared several key elements, including a systematic training of midwives in how to refer pregnant smokers, offering nicotine replacement treatment to almost all clients and having an efficient system of providing the prescriptions, offering flexible home visits, and providing intensive multi-session treatment delivered by a small number of dedicated staff. CONCLUSION: Smoking cessation services for pregnant women may need clearer guidance on what they are expected to provide, and how they should monitor their outcome. The key features of the beacon services can serve as a practical model of current best practice applicable across most PCTs.

Benchmarking↗
PubMed2005

Outcome criteria in smoking cessation trials: proposal for a common standard.

Smoking cessation treatment is now integrated into many health-care systems and a major research effort is under way to improve current success rates. Until now results from randomized clinical trials have been reported in many different ways, leading to problems of interpretation. We propose six standard criteria comprising the 'Russell Standard' (RS). These criteria are applicable to trials of cessation aids where participants have a defined target quit date and there is face-to-face contact with researchers or clinic staff, as follows. (1) Follow-up for 6 months (RS6) or 12 months (RS12) from the target quit date or the end of a predefined 'grace period'; (2) self-report of smoking abstinence over the whole follow-up period allowing up to five cigarettes in total; (3) biochemical verification of abstinence at least at the 6-month or 12-month follow-up point; (4) use of an 'intention-to-treat' approach in which data from all randomized smokers are included in the analysis unless they have died or moved to an untraceable address (participants who are included in the analysis are counted as smokers if their smoking status at the final follow-up cannot be determined); (5) following-up 'protocol violators' and using their true smoking status in the analysis; and (6) collecting follow-up data blind to smokers' allocation to trial group. We believe that these criteria provide the best compromise between practicability and surrogacy for long-term cessation and will enable meaningful comparison between studies. There may be good reasons why other outcome criteria would also be reported, and studies that involve interventions with special groups or where there is no designated target quit date or face to face contact would need to adapt these criteria accordingly.

Humans↗
PubMed2004

Increasing women's intentions to stop smoking following an abnormal cervical smear test result.

BACKGROUND: The aim of this study is to assess the impact of two leaflets upon intentions to stop smoking in the next month in women receiving abnormal cervical smear test results. METHODS: 330 women smokers who received an abnormal smear test result were randomly allocated to one of three groups: Group 1: sent a leaflet about the threat of cervical cancer from smoking and the benefits to cervical health in stopping, containing a detailed explanation of how smoking harms the cervix; Group 2: sent the same leaflet but without the detailed explanation; Group 3: no leaflet. Questionnaires were completed 1 month later. RESULTS: Women in Group 1 had higher intentions to stop smoking compared with Group 3. This effect was mediated by perceived coherence of the link between smoking and cervical cancer and moderated by self-efficacy (confidence): only women with high levels of self-efficacy had higher intentions to stop smoking. CONCLUSION: Explaining the link between smoking and cervical cancer increases intentions to stop smoking in women receiving abnormal cervical smear test results. Further studies are needed to determine how self-efficacy can be increased and whether, in addition to the detailed leaflet, this increases rates of smoking cessation.

Adult↗
PubMed2004

Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal.

RATIONALE: The mood and physical symptoms scale (MPSS) was developed in the early 1980s to assess cigarette withdrawal symptoms, and variants of it have been used for 20 years. To date, no paper has been published on the properties of the scale. OBJECTIVES: To evaluate psychometric properties of MPSS and the interrelationship between the key tobacco withdrawal symptoms. METHODS: The core elements of the MPSS involve 5-point ratings of depressed mood, irritability, restlessness, difficulty concentrating and hunger and 6-point ratings of strength of urges to smoke and time spent with these urges. The data set chosen for analysis was well suited to the task in that it involved a relatively large sample, abstinence was defined as "not a puff" for 24 h biochemically verified, participants were not using any medication that would have reduced withdrawal discomfort (e.show $132#g. nicotine patch), the abstinence rate was very high resulting in minimal bias due to attrition, and ratings were provided on three occasions prior to abstinence. The study involved 111 smokers setting a target quit date of whom 106 attempted abstinence and 96 achieved it. RESULTS: The MPSS items were stable prior to abstinence and sensitive to abstinence. Post-abstinence increases in mood and physical symptoms demonstrated a high level of internal coherence. Ratings of urges to smoke correlated highly with changes in mood and other symptoms. Ratings of hunger correlated less well with the scale as a whole and may involve some distinct processes. CONCLUSIONS: The MPSS meets the key requirements of a cigarette withdrawal scale. Although urge to smoke/craving was not included in the list of DSM-IV withdrawal symptoms, it should be regarded as forming part of the withdrawal syndrome.

Adult↗
PubMed2004

Effect of glucose on tobacco withdrawal symptoms in recent quitters using bupropion or nicotine replacement.

RATIONALE AND OBJECTIVES: Glucose has been shown to alleviate the desire to smoke in abstaining heavy smokers and to increase 1-month abstinence rates on its own as well as when combined with nicotine patches. It is not known whether a single dose of glucose can provide additional withdrawal relief in patients who have already abstained for a period of time, and whether it can assist patients using bupropion. METHODS: Seventy-five volunteers from a smoking cessation clinic who maintained 1 week of validated continuous abstinence were randomized to receive four 3 mg dextrose or placebo (sorbitol) tablets. There were 31 bupropion and 44 NRT users. Measures of desire to smoke and of five withdrawal symptoms were taken before taking the tablets, and then at 5 min intervals for 20 min. RESULTS: Despite low baseline ratings of withdrawal discomfort, glucose tablets significantly reduced irritability and hunger in bupropion users. Two other effects including reduction in composite withdrawal score approached but did not reach statistical significance. The effects emerged 10-15 min after taking the tablets. No glucose effect was detected in patients using NRT. CONCLUSIONS: A single dose of glucose taken after a week of sustained abstinence may reduce withdrawal discomfort in patients on bupropion. Further research is warranted in combining glucose and bupropion, and in opportunistic use of glucose tablets in tempting situations during a smoking cessation attempt.

Adult↗
PubMed2004

The relationship between smoking cessation and mouth ulcers.

Patients who stop smoking often complain of aphthous (mouth) ulcers. This symptom is sometimes attributed to the use of smoking cessation medications, but little is known about it. We investigated the incidence, severity, and time course of mouth ulcers in abstaining smokers and the effect of different smoking cessation medications on the symptom. The sample consisted of 1234 smokers who sought treatment at a large smoking cessation clinic, maintained at least 1 week of continuous biochemically validated abstinence, and provided usable data. Participants assessed their mouth ulcers by rating a mouth ulcer item added to the Mood and Physical Symptoms Scale. Subjects made ratings weekly on three occasions while still smoking and over 4 weeks following smoking cessation. After stopping smoking, some 40% of patients developed mouth ulcers, mostly in the first 2 weeks. The problem was generally mild, but 8% reported severe ulceration. The ulcers resolved within 4 weeks in 60% of patients affected. The ulcer ratings in patients using oral nicotine replacement products were higher than in those using patch, nasal spray or bupropion in the first week of abstinence but not afterward. Mouth ulcers were more prevalent in more dependent smokers, and the occurrence of ulcers correlated with other tobacco withdrawal symptoms. Our results confirm that mouth ulcers are a common result of stopping smoking, affecting two in five quitters. Patients should be reassured that the lesions are a result of stopping smoking and not a side-effect of smoking cessation medication.

Adult↗
PubMed2003

The use of videos to inform smokers about different nicotine replacement products.

This study examined the feasibility of using video presentations to inform smokers about nicotine replacement treatment (NRT). The study was part of a larger trial comparing four different NRTs. Five hundred and four smokers attended a clinic on the day they stopped smoking. They were presented with a brief video overview of the four treatments. They were then randomly allocated to a treatment and shown another brief video describing that treatment in more detail. After 1 week of NRT use, participants rated how clearly the video described how the treatments work, how to use them and their possible side effects. They also rated how their experience of the product compared to expectation in terms of helpfulness, convenience and side effects. The smokers reported overwhelmingly that the videos had accurately described the product to which they had been allocated. Video presentations can be an effective way to convey information to smokers about NRT.

Adult↗
PubMed2003

Stopping smoking can cause constipation.

SETTING: Constipation is mentioned occasionally as a possible tobacco withdrawal symptom, but no systematic data have been published on this issue. DESIGN: Smokers' clinic patients provided ratings of their level of constipation on three occasions prior to their quit date, and then weekly after they stopped smoking. The total of 1067 participants maintained at least 1 week of continuous abstinence and provided usable data. FINDINGS: The three precessation ratings of constipation were stable. After cessation of smoking, the ratings increased significantly (P < 0.01). In 514 patients who maintained continuous abstinence for 4 weeks and provided complete data, constipation peaked at 2 weeks but remained elevated over the whole period. The net proportion of patients affected was 17%, including 9% who were symptom-free at baseline and became very or extremely constipated. In patients on nicotine replacement the increase in constipation, although significant, was less than in patients on bupropion. CONCLUSIONS: Clinicians treating smokers need to be aware of a possibility that one in six quitters develop constipation, and that for about one in 11 the problem can be severe. Descriptions of tobacco withdrawal syndrome should include constipation.

Bupropion↗
PubMed2002

Efficacy of a nicotine lozenge for smoking cessation.

BACKGROUND: Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation. METHODS: Double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms. RESULTS: Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the 4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum. CONCLUSION: The nicotine lozenge is a safe and effective new treatment for smoking cessation in low- and high-dependence smokers.

Adult↗
PubMed2002

Brief intervention during hospital admission to help patients to give up smoking after myocardial infarction and bypass surgery: randomised controlled trial.

OBJECTIVE: To evaluate a smoking cessation intervention that can be routinely delivered to smokers admitted with cardiac problems. DESIGN: Randomised controlled trial of usual care compared with intervention delivered on hospital wards by cardiac rehabilitation nurses. SETTING: Inpatient wards in 17 hospitals in England. PARTICIPANTS: 540 smokers admitted to hospital after myocardial infarction or for cardiac bypass surgery who expressed interest in stopping smoking. INTERVENTION: Brief verbal advice and standard booklet (usual care). Intervention lasting 20-30 minutes including carbon monoxide reading, special booklet, quiz, contact with other people giving up, declaration of commitment to give up, sticker in patient's notes (intervention group). MAIN OUTCOME MEASURES: Continuous abstinence at six weeks and 12 months determined by self report and by biochemical validation at these end points. Feasibility of the intervention and delivery of its components. RESULTS: After six weeks 151 (59%) and 159 (60%) patients remained abstinent in the control and intervention group, respectively (P=0.84). After 12 months the figures were 102 (41%) and 94 (37%) (P=0.40). Recruitment was slow, and delivery of the intervention was inconsistent, raising concerns about the feasibility of the intervention within routine care. Patients who received the declaration of commitment component were almost twice as likely to remain abstinent than those who did not receive it (P<0.01). Low dependence on tobacco and high motivation to give up were the main independent predictors of positive outcome. Patients who had had bypass surgery were over twice as likely to return to smoking as patients who had had a myocardial infarction. CONCLUSIONS: Single session interventions delivered within routine care may have insufficient power to influence highly dependent smokers.

Adult↗