Transdermal nicotine for smoking cessation: six-month results from two multicenter controlled clinical trials
Article Abstract:
The effectiveness of a transdermal nicotine system (a nicotine-impregnated gel placed on the skin) was investigated in a multi-center trial. This system promotes smoking cessation by delivering nicotine continuously at a fixed rate. Two 6-week controlled trials and an 18-week continuation trial (for those who stopped smoking) were carried out at 9 outpatient clinics. Subjects were 935 healthy adults who smoked at least one pack of cigarettes per day. They were randomly assigned to either the transdermal nicotine system group at doses of 21, 14, or 7 milligrams of nicotine per day or the placebo group, which received less than 1 milligram of nicotine per day. All patients received supportive group counseling. Twenty-seven percent of the subjects withdrew from the study before it ended. Smoking cessation rates were greater for the 21-, 14-, and 7-milligram-per-day transdermal nicotine groups than for the placebo groups in both trials. Cessation rates were 61 percent with the 21 milligram-per-day dose, 48 percent with the 14 milligram-per-day dose, and 27 percent for the placebo groups. Patients who smoked more cigarettes when the study began were less likely to stop smoking. All treatment groups had the same rate of relapse. After six months, abstinence rates were 26 percent for the 21-milligram groups and 12 percent for the placebo groups. The 242 patients who did not stop smoking smoked fewer cigarettes after the trials. Nicotine withdrawal symptoms were reduced for all subjects who received nicotine compared with those who received the placebo. These findings demonstrate that transdermal nicotine is a promising aid for smoking cessation. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1991
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Transdermal fentanyl for postoperative pain management: a double-blind placebo study
Article Abstract:
Newly developed drug delivery technology allows the administration of a drug across an intact skin. The method uses a skin patch with a membrane that controls the rate of medication absorption across the skin (transdermal administration). In the current report, fentanyl citrate, a strong synthetic narcotic, is administered to patients via a transdermal skin patch following surgery. The use of postoperative morphine is evaluated in patients who had shoulder surgery by local anesthesia. The patients were divided into two groups: those who received a fentanyl skin patch and those who did not. Shoulder surgery was chosen since patients usually experience a 24- to 48-hour period of severe pain following the operation and because the effects of general anesthesia do not need to be controlled. Serum levels of fentanyl citrate were obtained for the patients who received an active patch. A pharmacologic level was achieved rapidly after applying the patch and it was maintained for at least 12 hours following removal of the patch. Patients receiving the fentanyl patch required significantly less postsurgical morphine than did the placebo control group. Although the incidence of vomiting was higher in the fentanyl group, transdermal fentanyl appears to be both safe and effective for healthy adult surgical orthopedic patients.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1989
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A double-blind trial of a nicotine inhaler for smoking cessation
Article Abstract:
A nicotine inhaler may be an effective and safe treatment for individuals trying to quit smoking. Different types of nicotine substitution used by individuals trying to quit smoking include nicotine chewing gum, nicotine transdermal patches or nicotine nasal spray. Among 286 individuals who smoked at least 10 cigarettes a day, 145 used a nicotine inhaler as often as they wanted and 141 used an inhaler with a placebo, or an inactive substance. Twenty-eight percent of the individuals in the nicotine group had not smoked six weeks after beginning treatment, compared with 12% of the individuals in the placebo group. Fifteen percent of the individuals who used the nicotine inhaler had not smoked one year after beginning treatment, compared with 5% of the individuals who used a placebo inhaler. None of the individuals who used the nicotine inhaler experienced any adverse side effects.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1993
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