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At least 145 records · Page 8Linked to original sources
PubMed1998

Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation.

Smoking cessation is an arduous process because nicotine withdrawal syndrome, which occurs following sudden interruption of nicotine use in long-term smokers, frequently prevents them from giving up the habit. Nicotine supplement systems may relieve smokers' nicotine withdrawal symptoms and, thus, help in the process of abstinence from smoking. The purpose of the present study was to investigate the effectiveness and safety of a 30-mg transdermal nicotine patch in a smoking cessation program for Chinese smokers. In this randomized, double-blind, placebo-controlled study, 30 heavy smokers, who had smoked more than 20 cigarettes per day for more than a year, were treated with 30-mg transdermal nicotine patches, and 32 heavy smokers were given placebo patches during a 6-week smoking cessation program. The clinical characteristics of the two groups were similar. After 6 weeks, the use of the transdermal nicotine patch was associated with markedly reduced nicotine dependence and severity of withdrawal symptoms. Nineteen (63%, 95% confidence interval, CI, 46%-80%) of the smokers treated with the transdermal nicotine patch had successfully quit smoking at the end of the program (6 weeks) and nine (30%, 95% CI 14%-46%) remained abstinent 1 year later. In contrast, only 11 (34%, 95% CI 18%-50%) of the smokers in the placebo group had successfully stopped smoking after 6 weeks, and three remained abstinent 1 year later (9%, 95% CI 0%-19%). However, there was no statistically significant difference between the two groups of smokers after 1 year of follow-up (p = 0.08). Side-effects were minimal and did not affect the efficacy of the skin patch. The results indicate that the transdermal nicotine patch is an effective aid in smoking cessation programs.

Administration, Cutaneous↗
PubMedDate not supplied

Transdermal fentanyl patches in small animals.

Fentanyl citrate is a potent opioid that can be delivered by the transdermal route in cats and dogs. Publications regarding transdermal fentanyl patches were obtained and systematically reviewed. Seven studies in cats and seven studies in dogs met the criteria for inclusion in this review. Dogs achieved effective plasma concentrations approximately 24 hours after patch application. Cats achieved effective plasma concentrations 7 hours after patch application. In dogs, transdermal fentanyl produced analgesia for up to 72 hours, except for the immediate 0- to 6-hour postoperative period. In cats, transdermal fentanyl produced analgesia equivalent to intermittent butorphanol administration for up to 72 hours following patch application.

Administration, Cutaneous↗
PubMed1993

An Australian experience of transdermal oestradiol patches in a subtropical climate.

Tolerability and efficacy of transdermal oestradiol patches were assessed in 121 menopausal women over a period of 3 months to 2.5 years. Of particular interest, in a subtropical climate such as Brisbane, were the problems associated with adhesiveness and skin irritation during the summer months. We conducted a retrospective study with self-administered questionnaires. All patients had been selected for the nonoral route because of side-effects or relative contraindications to oral therapy. There was, overall, good efficacy and acceptability. The majority of the women found the patch very adequate in relieving symptoms of the menopause (vasomotor, genitourinary and musculoskeletal). Most preferred the patch to oral therapy. The oestradiol patch was well tolerated and few side-effects were reported. Breast tenderness and weight gain were 2 minor problems associated with its use. Skin irritation was minimal, but adhesiveness was a problem during the summer months, especially with swimming or showering. Some practical suggestions were obtained about how to overcome site of application problems.

Adhesiveness↗
PubMed2004

A comparison of a novel testosterone bioadhesive buccal system, striant, with a testosterone adhesive patch in hypogonadal males.

A novel delivery system has been developed for testosterone replacement. This formulation, COL-1621 (Striant), a testosterone-containing buccal mucoadhesive system, has been shown in preliminary studies to replace testosterone at physiological levels when used twice daily. Therefore, the current study compared the steady-state pharmacokinetics and tolerability of the buccal system with a testosterone-containing skin patch (Andropatch or Androderm) in an international multicenter study of a group of hypogonadal men. Sixty-six patients were randomized into two groups; one applied the buccal system twice daily, whereas the other applied the transdermal patch daily, in each case for 7 d. Serum total testosterone and dihydrotestosterone concentrations were measured at d 1, 3 or 4, and 6, and serially over the last 24 h of the study. Pharmacokinetic parameters for each formulation were calculated, and the two groups were compared. The tolerability of both formulations was also evaluated. Thirty-three patients were treated with the buccal preparation, and 34 were treated with the transdermal patch. The average serum testosterone concentration over 24 h showed a mean of 18.74 nmol/liter (SD =; 5.90) in the buccal system group and 12.15 nmol/liter (SD =; 5.55) in the transdermal patch group (P < 0.01). Of the patients treated with the buccal system, 97% had average steady-state testosterone concentrations within the physiological range (10.41-36.44 nmol/liter), whereas only 56% of the transdermal patch patients achieved physiological total testosterone concentrations (P < 0.001 between groups). Testosterone concentrations were within the physiological range in the buccal system group for a significantly greater portion of the 24-h treatment period than in the transdermal patch group (mean, 84.9% vs. 54.9%; P < 0.001). Testosterone/dihydrotestosterone ratios were physiological and similar in both groups. Few patients experienced major adverse effects from either treatment. No significant local tolerability problems were noted with the buccal system, other than a single patient withdrawal. We conclude that this buccal system is superior to the transdermal patch in achieving testosterone concentrations within the normal range. It may, therefore, be a valuable addition to the range of choices for testosterone replacement therapy.

Administration, Buccal↗
PubMed1994

The transdermal nicotine patch: results of a randomised placebo-controlled trial.

OBJECTIVES: To evaluate the efficacy of the transdermal nicotine patch as an aid to smoking cessation when used as an adjunct to a cognitive-behavioural group intervention and to assess the effectiveness of the patch in ameliorating withdrawal symptoms. DESIGN AND SETTING: Double-blind placebo-controlled randomised trial with six months' follow-up of those who returned to the hospital-based outpatients smoking cessation clinic. SUBJECTS: Three hundred and thirteen smokers recruited from the local community. Mean age was 42 years, 48% were male, mean cigarette consumption was 29 per day and mean duration of smoking was 24 years. INTERVENTION: Cognitive-behavioural intervention delivered in a group context, two hours once a week over five weeks, self-help manual, and 24-hour daily nicotine patch treatment for 10 weeks. MAIN OUTCOME MEASURES: Point prevalence abstinence at three and six months, and sustained cessation from end of treatment to six months, with biochemical validation (expired carbon monoxide). We examined the effectiveness of the nicotine patch in ameliorating specific withdrawal symptoms by self-report of degree of severity. RESULTS: The active nicotine patch resulted in significantly higher biochemically confirmed abstinence rates when compared with placebo at three months (48% v. 21%) and at six months (33% v. 14%). Six-months' continuous abstinence rates were also significantly higher among the active nicotine group (25%) compared with placebo (12%). The most common adverse events among active patch users were sleep disturbance and local skin irritation. The nicotine patch reduced the severity of some withdrawal symptoms. A low level of dependence was the strongest predictor of three and six months' abstinence. CONCLUSIONS: The transdermal nicotine patch is effective when used as an adjunct to a group cognitive-behavioural intervention and it provides relief from withdrawal symptoms associated with nicotine dependence.

Administration, Cutaneous↗
PubMed1993

Transdermal nicotine patches with low-intensity support to aid smoking cessation in outpatients in a general hospital. A placebo-controlled trial.

OBJECTIVE: To assess whether transdermal nicotine patches combined with low-intensity support can help outpatients in a general hospital stop smoking. DESIGN: Randomized, double-blind, placebo-controlled trial with 12 weeks of follow-up. SETTING: Department of Thoracic Medicine in an inner-city public general hospital, London, England. SUBJECTS: Two hundred forty-eight outpatients in a general hospital, who smoked at least 10 cigarettes per day (the majority were being treated for smoking-related diseases), referred by clinicians at the hospital. INTERVENTION: Brief advice to stop smoking and daily application of transdermal nicotine patches (delivering 15 mg over 16 hours) or placebo, with follow-up appointments at 1, 3, 6, and 12 weeks, with a doubling of the dosage for continuing smokers at week 1. MAIN OUTCOME MEASURE: Sustained abstinence from tobacco from week 3 to week 12 validated with measurement of expired-air carbon monoxide concentration at weeks 3, 6, and 12. RESULTS: Twenty-nine (23.4%) of 124 subjects assigned to the nicotine group were validated as having abstained from smoking at both weeks 3 and 6, compared with 16 (12.9%) of 124 subjects receiving placebo (P = .008). At week 12, 22 (17.7%) of the subjects in the nicotine group were validated as having abstained at all three points as were 15 (12.1%) of the subjects in the placebo group (P = .058). CONCLUSION: Transdermal nicotine patches combined with low-intensity support are effective in helping outpatients in a general hospital stop smoking but do not prevent relapse after 6 weeks.

Administration, Cutaneous↗
PubMed1993

Effectiveness of a 16-hour transdermal nicotine patch in a medical practice setting, without intensive group counseling.

BACKGROUND: To determine the effectiveness of a 16-hour transdermal nicotine patch in assisting smokers to stop smoking, when used in a primary medical practice model. METHODS: A single-site, randomized, double-blind, out-patient, parallel-group, placebo-controlled trial consisting of 220 regular, otherwise healthy cigarette smokers. Patients participated in a 12-week patch treatment phase plus a 6-week tapering phase. A standard medical office model of physician intervention, such as could easily be employed by any primary care physician, without need for any special psychological services, training, or skills, was the behavioral intervention. RESULTS: Sustained abstinence, determined at each visit by absolutely no cigarette use, carbon monoxide level of 9 ppm or less, and serum cotinine level of 15 ng/mL or less (after week 18), was significantly greater for those patients receiving the active nicotine patch than for those receiving the placebo patch: the percent of patients not smoking at 6, 12, 18, 26, and 52 weeks was 61% vs 35%, 45% vs 26%, 41% vs 16%, 34% vs 12%, and 25% vs 9%, respectively (P < .001). This 16-hour nicotine patch produced no systemic side effects and minimal skin irritation. CONCLUSIONS: Nicotine replacement therapy via a 16-hour transdermal nicotine patch provided safe and effective treatment for tobacco-dependent patients. One-year sustained nonsmoking rates were nearly three times higher in the active than in the placebo condition, when the patch was used in an easily applicable standard medical practice setting, without the need for psychological interventions. This outcome was as good as or better than results achieved by nicotine patches using behavior modification or group counseling.

Administration, Cutaneous↗
PubMed2000

Comparative efficacy of 24-hour and 16-hour transdermal nicotine patches for relief of morning craving.

AIMS: To compare a transdermal nicotine patch designed for 24-hour wear with one designed for 16-hour wear for relief of craving and withdrawal, particularly in the morning hours. DESIGN: Smokers were randomly assigned to use one of two common patch regimens: NicoDerm/NiQuitin (24-hour wear, 21 mg nicotine) or Nicotrol/Nicorette (16-hour wear, 15 mg). In a double-dummy design, participants wore two patches during the day, one active, one placebo and one patch while sleeping. SETTING: A smoking cessation research clinic. PARTICIPANTS: Two hundred and forty-four smokers who suffered morning cravings. INTERVENTION: Two patch formulations approved and marketed for over-the-counter use in the US--NicoDerm CQ (labeled as 21 mg over 24 hours) and Nicotrol (labeled as 15 mg over 16 hours)--were each used according to its instructions. Smokers also received behavioral counseling. MEASUREMENTS: For a week of baseline and 2 weeks after quitting, smokers used palm-top computers to assess craving and withdrawal symptoms several times each day. FINDINGS: The 21 mg/24-hour patch yielded consistently better control of craving, not only during the morning hours, but throughout the day, and over the 2-week period of abstinence. Additionally, the 21 mg/24-hour patch yielded greater reductions in anxiety, irritability and restlessness. Smokers using the 21 mg/24-hour dosing regimen also experienced longer abstinence than those using the 15 mg/16-hour patch. CONCLUSIONS: These findings demonstrate that 24-hour dosing with a 21 mg patch affords superior relief of craving and withdrawal during the first 2 weeks of abstinence, when symptoms are at their peak, and when relapse is most likely. They confirm the importance of dosing parameters in nicotine replacement products.

Administration, Cutaneous↗
PubMed1995

Smoking cessation: a clinical study of the transdermal nicotine patch.

Although cigarette smoking is a declining trend in the United States, the amount of cigarettes consumed by the American public is the same today as in 1964. The role of cigarette smoking in many disease processes is publicly well known, and smoking cessation has been proved to reduce risk for some diseases, but the various methods of cessation are often met with a high rate of treatment failure or relapse. In this study, the short-term efficacy of nicotine-replacement therapy by way of the transdermal patch system was evaluated in 110 patients in a family practice setting. Patches were tapered from 21 mg of nicotine to 14 mg to 7 mg, each for 30 days. Subjects wore one patch for every 24 hours and were instructed not to smoke. Telephone follow-up was used at 2 to 3 weeks to check smoking status and inquire for side effects, and further follow-up of those who had completed the 3-month program was initiated 6 months after the program began. Nineteen patients never filled the prescription, and six were lost to follow-up. Of the 85 who finished the program, 35% were still not smoking at 6 months after the study began. The other 65% had relapsed. Side effects were mild and were mainly related to skin irritation at the patch site and abnormal dreams. Combinations of this cessation method with physician counseling and other behavioral methods should improve the success rate of this encouraging treatment.

Administration, Cutaneous↗
PubMed2005

Preference for and satisfaction of Canadian women with the transdermal contraceptive patch versus previous contraceptive method: an open-label, multicentre study.

OBJECTIVE: To document Canadian women's experience with the transdermal contraceptive patch, a method delivering 150 microg norelgestromin and 20 microg ethinyl estradiol daily. METHODS: We conducted an open-label, multicentre, descriptive cohort study of the contraceptive patch over 9 cycles in 392 women requiring contraception. A single treatment cycle consisted of 3 consecutive 7-day patch applications followed by 1 patch-free week. At the final visit, overall satisfaction and preference for the patch was rated and compared with the previously used contraceptive method. RESULTS: At baseline, 80.9% of participants were either very satisfied or somewhat satisfied with their previous contraceptive method, 89% having used oral contraceptives. At final observation, 60.6% of participants preferred the patch, 9.3% had no preference; and 30% preferred their previous method (n = 376). A total of 279 participants (71.2%) completed 9 cycles of patch use. Of these, 91% were satisfied with the patch and 74.9% preferred the patch to their previous contraceptive (43% strongly preferred and 31.9% preferred); 9% had no preference; and 16.1% preferred their previous method. Of those who preferred the patch, 82.7% preferred it because of its convenience or simplicity. Across all cycles, 88% of participants recorded perfect compliance. The most common adverse event was application site reactions (most of which were mild), experienced by 49% of participants: 33.7%, 16.5%, and 14.7% at cycles 1, 4, and 9, respectively. CONCLUSION: Both preference for and satisfaction with the transdermal contraceptive patch were high. Most participants.

Administration, Cutaneous↗
PubMed1998

Evaluation of the information processing and mood effects of a transdermal nicotine patch.

The purpose of this study was to determine whether a transdermal nicotine patch will produce the same effects on performance and mood as cigarette smoking. The nicotine patch improved attentional processing and produced some improvements in memory. It produced the calming effects of smoking and induced feelings of happiness which were increased with smoking. These effects were obtained 6 h after application of the patch, showing that acute tolerance for these behavioural effects had not developed completely, if at all, after exposure to nicotine, although it is still possible that tolerance might occur with longer exposure.

Administration, Cutaneous↗
PubMed2005

Nicotine inhibits pulsatile luteinizing hormone secretion in human males but not in human females, and tolerance to this nicotine effect is lost within one week of quitting smoking.

CONTEXT AND OBJECTIVE: Despite having increased knowledge of the adverse reproductive effects of smoking, it is unclear whether nicotine affects the pulsatile LH secretion in humans. We addressed this issue in male and female smokers and nonsmokers. SUBJECTS AND METHODS: Twenty-nine male and 16 female nonsmokers and smokers were recruited as volunteers. In male smokers, nicotine effect was also studied before and after quitting smoking. In females, cyclic ovulatory function was assessed by measuring basal body temperature, and sampling studies were performed during the follicular phase. In the morning of the sampling day, an iv catheter was inserted into an anterobrachial vein, and blood samples (1.0-1.5 ml each) were taken at 10-min intervals for 480 min, during which, at 240 min, nicotine was administered via a transdermal patch (Nicotinell transdermal therapeutic system) containing 17.5 mg nicotine. Plasma LH was measured by immunoradiometric assay kits. RESULTS: Nicotine significantly lengthened the interpulse interval of pulsatile LH secretion in male nonsmokers but not in female nonsmokers. In male smokers, nicotine did not lengthen the interpulse interval, and in female smokers it was also ineffective. After quitting cigarette smoking in male smokers, the refractory to nicotine effect disappeared within 1 wk. CONCLUSIONS: We conclude that nicotine inhibits pulsatile LH secretion only in males, and the tolerance developed to the nicotine effect disappears within 1 wk of quitting cigarette smoking. However, we cannot deny the possibility that nicotine effect would have been detected in females if more subjects had been studied.

Drug Tolerance↗
PubMed1992

Effect of transdermal nicotine patches on cigarette smoking: a double blind crossover study.

The effect of transdermal nicotine patches on ad libitum cigarette smoking was examined in 30 subjects by measuring behavioural, biochemical and subjective aspects of smoking during a week of smoking without patches, and then a week each of nicotine and placebo patches in a randomised double blind crossover design. While wearing nicotine patches the subjects did not reduce the number of cigarettes smoked, but their expired carbon monoxide was reduced by 14%, they obtained less satisfaction from their cigarettes, and reported fewer and weaker urges to smoke. Down-regulation of nicotine intake from cigarettes was imprecise, such that when subjects wore nicotine patches their post-cigarette plasma nicotine concentration increased to an average of 45 ng/ml compared with 37 ng/ml in both no patch and placebo patch conditions. As the nicotine patches produced a plasma nicotine concentration of 15.9 ng/ml in abstinent subjects, this suggests a 22% reduction in nicotine intake from cigarettes while wearing nicotine patches. No serious symptoms of nicotine overdose were reported. It is suggested that the continuous absorption of nicotine from the patch may cause a build-up of acute tolerance to both toxic and pleasant subjective effects from smoking.

Administration, Cutaneous↗
PubMed1995

Trial of transdermal nicotine patch in smoking cessation.

In order to evaluate the efficacy of the transdermal nicotine patch, 37 persons who wore the patches (group 2) were compared with 40 persons who attended an organized smoking cessation program (group 1). At 1 month, 8 persons of group 2 (21.62%) and 22 persons of group 1 (55%) were able to stop smoking. At 3 months, 8 persons of group 2 (21.62%) and 17 persons of group 1 (42.5%) were still abstinent. At 6 months, 7 persons of group 2 (18.9%) and 14 persons of group 1 (35%) were able to stop smoking. At 12 months, 5 persons of group 2 (13.5%) were able to maintain their abstinence. Counselling and follow-up support are needed to maintain abstinence.

Adolescent↗
PubMed1994

Trial of transdermal nicotine patch in smoking cessation.

In order to evaluate the efficacy of the transdermal nicotine patch, 37 persons who wore the patches (group 2) were compared with 40 persons who attended an organized smoking cessation program (group 1). At 1 month, 8 persons of group 2 (21.62%) and 22 persons of group 1 (55%) were able to stop smoking. At 3 months, 8 persons of group 2 (21.62%) and 17 persons of group 1 (42.5%) were still abstinent. At 6 months, 7 persons of group 2 (18.9%) and 14 persons of group 1 (35%) were able to quit smoking. Counselling and follow-up support are needed to maintain abstinence.

Administration, Cutaneous↗
PubMed1999

Transdermal nicotine patches do not cause clinically significant gastroesophageal reflux or esophageal motor disorders.

Transdermal nicotine delivery systems are widely used in smoking cessation. The purpose of this study was to determine whether common symptoms of pyrosis and dyspepsia associated with these patches are related to gastroesophageal reflux or esophageal dysmotility. Twenty-seven paid volunteer cigarette smokers (> 15 cigarettes/day) without symptomatic gastroesophageal reflux disease participated in this single-blinded, placebo-controlled study. Twenty subjects completed the study. Subjects underwent three sequential 24-h intraesophageal pH/motor studies (Synectics model T32342084, Shore View, MN). The pH/motility probe was positioned 5 cm above the manometrically determined LES. A placebo patch was applied for the first 24-h study and a 15-mg nicotine patch (Nicotrol) was applied for the initial 16 h (removed for remaining 8 h) of the second 24-h period. A 21-mg nicotine patch (Nicoderm) was applied for another 24-h study period. All subjects consumed an identical, defined diet documented by meal receipts, and refrained from smoking and tobacco use throughout the study periods (CO breath test confirmation). The Wilcoxon, paired t-test, exact McNemar statistical methods were used. The results showed that there were no significant differences in reflux symptoms (pyrosis, chest pain, nausea, dysphagia), supine gastroesophageal reflux (number of episodes, duration, or cumulative acid exposure), or the total number of reflux episodes between placebo and nicotine patch treatment periods. The number of post-prandial upright acid reflux episodes (p = 004) and number of upright acid reflux episodes lasting more than 5 min (p = 0.007) were statistically higher with the placebo patch compared to the active nicotine patches. No differences in intraesophageal pH or motility indices were noted between the two transdermal nicotine patches (Nicotrol, Nicoderm). It was concluded that dyspeptic symptoms in subjects utilizing transdermal nicotine patches are not related to gastroesophageal reflux or to esophageal motor abnormalities.

Administration, Cutaneous↗
PubMed1995

Efficacy and tolerability of Menorest 50 compared with Estraderm TTS 50 in the treatment of postmenopausal symptoms. A randomized, multicenter, parallel group study.

Two-hundred and five (205) menopausal women with moderate to severe vasomotor symptoms, aged 39-64 years, were randomized from 20 clinical centers. After a 4-week treatment-free period, each woman received a cyclical regimen (25 days of a 4-week cycle) of Menorest 50, a new matrix-type transdermal estradiol system or Estraderm TTS 50, a marketed reservoir-type transdermal estradiol system twice weekly for 12 weeks. An oral progestin was also given for 10 days each cycle. The objectives were to compare local and systemic tolerability and efficacy in the treatment of menopausal symptoms. One-hundred and ninety-four [194] patients (96 and 98 patients in the Menorest 50 and the reservoir transdermal patch groups, respectively) were considered in the intent-to-treat population and 204 (102 in each group) in the safety population. The two treatment groups were comparable with regard to the demographic data and menopausal status. The primary efficacy criteria were the comparison between Menorest 50 and the reservoir transdermal patch in erythema and pruritus at application sites and the difference between the treatment groups in the mean number of hot flushes per day at week 12, adjusted for baseline. A statistically significant reduction in the mean number of hot flushes was observed in each group compared with baseline, with a decrease from 6.5 at baseline to 0.3 at 12 weeks and 6.4 to 0.4 in the Menorest 50 and reservoir transdermal patch groups respectively; there was no statistically significant difference between the two groups during the 12-week treatment. The severity score of menopausal symptoms was also dramatically improved in each of the two treatment groups. There were no statistically significant differences in the mean plasma estradiol concentrations and mean estradiol to estrone ratio (> 1.0) in both groups after 10 weeks of therapy. A similar number of adverse events was observed in both groups. Menorest 50 showed better local tolerability than the reservoir transdermal patch with a lower incidence of topical adverse events, erythema and pruritus. In summary, Menorest 50 was as effective as the reservoir transdermal patch in reducing the mean number of hot flushes, and improving the severity of other menopausal symptoms, including vasomotor, psychiatric and urogenital symptoms.

Administration, Cutaneous↗
PubMed2000

Effects of transdermal nicotine patches on abstinence-induced and cue-elicited craving in cigarette smokers.

The impact of a transdermal nicotine patch on smokers' craving for cigarettes and reactivity to smoking cues was investigated. Sixty-one smokers were assessed during 2 sessions separated by 6 hr. Cue reactivity to imaginal and in vivo smoking and nonsmoking stimuli was evaluated during both sessions. During the interval between sessions, participants were abstinent from cigarettes and wore either a nicotine transdermal (21 mg) or placebo patch. In both sessions, exposure to in vivo and imaginal smoking stimuli elicited cue-specific increases in craving, negative affect, vividness, heart rate, and skin conductance. The nicotine patch attenuated craving and other effects induced by abstinence from cigarettes but had no selective impact on craving or any other reaction elicited by smoking cues. These results are discussed in terms of models of craving and clinical implications of transdermal nicotine for craving reduction.

Administration, Cutaneous↗