Transdermal Clonidine Reduced Some Withdrawal Symptoms but Did not Increase Smoking Cessation

Allan V. Prochazka, Thomas L. Petty, Louise Nett, G. Wayne Silvers, David P.L. Sachs, Stephen I. Rennard, David M. Daughton, Richard H. Grimm, Craig Heim

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Background.—Clonidine may be useful in controlling tobacco withdrawal and in facilitating smoking cessation. This study was developed to test the efficacy of transdermal clonidine in promoting smoking cessation. Methods.—We conducted a five-center, double-blind, placebo-controlled, randomized controlled trial of transdermal clonidine in conjunction with a minimal behavioral intervention for smoking cessation. The intervention was based on the American Lung Association’s Freedom From Smoking program. Self report of not smoking was validated with exhaled air carbon monoxide of less than 8 ppm and salivary cotinine of less than 20 ng/mL. Transdermal clonidine therapy began 1 week before the target quit date: 0.1 mg/24 h for the first 4 days increasing to 0.2 mg/24 h for the next 3 days, if the lower dose was tolerated. The highest tolerated dose was then continued for 6 weeks after target quit day. Withdrawal symptoms were measured daily for the first 7 days after target quit day. Results.—A total of 213 patients were enrolled (106 active drug and 107 placebo). During the study, 15.5% of patients had drug therapy discontinued due to adverse effects, 24.5% (26/106) taking active drug vs 8.4% (9/107) receiving placebo. There was a significant reduction in anxiety score from 3.0 to 2.4 (placebo vs active) and irritability score from 2.2 to 1.7 (placebo vs active) during the first week after cessation. There was no reduction in other withdrawal symptoms. The overall 12-week abstinence rate was 33.0% (35/106) in the active drug group vs 34.5% (37/107) in the placebo group (not significant). Conclusions.—This study demonstrated some reduction in early withdrawal symptoms with the use of a clonidine transdermal patch, but no increase in cessation rate, 6 weeks after medication had been discontinued.

Original languageEnglish (US)
Pages (from-to)2065-2069
Number of pages5
JournalArchives of Internal Medicine
Volume152
Issue number10
DOIs
StatePublished - Oct 1992

Fingerprint

Substance Withdrawal Syndrome
Clonidine
Smoking Cessation
Placebos
Smoking
Pharmaceutical Preparations
Transdermal Patch
Cotinine
Carbon Monoxide
Self Report
Tobacco
Anxiety
Randomized Controlled Trials
Air
Drug Therapy
Lung

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Prochazka, A. V., Petty, T. L., Nett, L., Silvers, G. W., Sachs, D. P. L., Rennard, S. I., ... Heim, C. (1992). Transdermal Clonidine Reduced Some Withdrawal Symptoms but Did not Increase Smoking Cessation. Archives of Internal Medicine, 152(10), 2065-2069. https://doi.org/10.1001/archinte.1992.00400220083015

Transdermal Clonidine Reduced Some Withdrawal Symptoms but Did not Increase Smoking Cessation. / Prochazka, Allan V.; Petty, Thomas L.; Nett, Louise; Silvers, G. Wayne; Sachs, David P.L.; Rennard, Stephen I.; Daughton, David M.; Grimm, Richard H.; Heim, Craig.

In: Archives of Internal Medicine, Vol. 152, No. 10, 10.1992, p. 2065-2069.

Research output: Contribution to journalArticle

Prochazka, AV, Petty, TL, Nett, L, Silvers, GW, Sachs, DPL, Rennard, SI, Daughton, DM, Grimm, RH & Heim, C 1992, 'Transdermal Clonidine Reduced Some Withdrawal Symptoms but Did not Increase Smoking Cessation', Archives of Internal Medicine, vol. 152, no. 10, pp. 2065-2069. https://doi.org/10.1001/archinte.1992.00400220083015
Prochazka, Allan V. ; Petty, Thomas L. ; Nett, Louise ; Silvers, G. Wayne ; Sachs, David P.L. ; Rennard, Stephen I. ; Daughton, David M. ; Grimm, Richard H. ; Heim, Craig. / Transdermal Clonidine Reduced Some Withdrawal Symptoms but Did not Increase Smoking Cessation. In: Archives of Internal Medicine. 1992 ; Vol. 152, No. 10. pp. 2065-2069.
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title = "Transdermal Clonidine Reduced Some Withdrawal Symptoms but Did not Increase Smoking Cessation",
abstract = "Background.—Clonidine may be useful in controlling tobacco withdrawal and in facilitating smoking cessation. This study was developed to test the efficacy of transdermal clonidine in promoting smoking cessation. Methods.—We conducted a five-center, double-blind, placebo-controlled, randomized controlled trial of transdermal clonidine in conjunction with a minimal behavioral intervention for smoking cessation. The intervention was based on the American Lung Association’s Freedom From Smoking program. Self report of not smoking was validated with exhaled air carbon monoxide of less than 8 ppm and salivary cotinine of less than 20 ng/mL. Transdermal clonidine therapy began 1 week before the target quit date: 0.1 mg/24 h for the first 4 days increasing to 0.2 mg/24 h for the next 3 days, if the lower dose was tolerated. The highest tolerated dose was then continued for 6 weeks after target quit day. Withdrawal symptoms were measured daily for the first 7 days after target quit day. Results.—A total of 213 patients were enrolled (106 active drug and 107 placebo). During the study, 15.5{\%} of patients had drug therapy discontinued due to adverse effects, 24.5{\%} (26/106) taking active drug vs 8.4{\%} (9/107) receiving placebo. There was a significant reduction in anxiety score from 3.0 to 2.4 (placebo vs active) and irritability score from 2.2 to 1.7 (placebo vs active) during the first week after cessation. There was no reduction in other withdrawal symptoms. The overall 12-week abstinence rate was 33.0{\%} (35/106) in the active drug group vs 34.5{\%} (37/107) in the placebo group (not significant). Conclusions.—This study demonstrated some reduction in early withdrawal symptoms with the use of a clonidine transdermal patch, but no increase in cessation rate, 6 weeks after medication had been discontinued.",
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AU - Petty, Thomas L.

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AU - Silvers, G. Wayne

AU - Sachs, David P.L.

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N2 - Background.—Clonidine may be useful in controlling tobacco withdrawal and in facilitating smoking cessation. This study was developed to test the efficacy of transdermal clonidine in promoting smoking cessation. Methods.—We conducted a five-center, double-blind, placebo-controlled, randomized controlled trial of transdermal clonidine in conjunction with a minimal behavioral intervention for smoking cessation. The intervention was based on the American Lung Association’s Freedom From Smoking program. Self report of not smoking was validated with exhaled air carbon monoxide of less than 8 ppm and salivary cotinine of less than 20 ng/mL. Transdermal clonidine therapy began 1 week before the target quit date: 0.1 mg/24 h for the first 4 days increasing to 0.2 mg/24 h for the next 3 days, if the lower dose was tolerated. The highest tolerated dose was then continued for 6 weeks after target quit day. Withdrawal symptoms were measured daily for the first 7 days after target quit day. Results.—A total of 213 patients were enrolled (106 active drug and 107 placebo). During the study, 15.5% of patients had drug therapy discontinued due to adverse effects, 24.5% (26/106) taking active drug vs 8.4% (9/107) receiving placebo. There was a significant reduction in anxiety score from 3.0 to 2.4 (placebo vs active) and irritability score from 2.2 to 1.7 (placebo vs active) during the first week after cessation. There was no reduction in other withdrawal symptoms. The overall 12-week abstinence rate was 33.0% (35/106) in the active drug group vs 34.5% (37/107) in the placebo group (not significant). Conclusions.—This study demonstrated some reduction in early withdrawal symptoms with the use of a clonidine transdermal patch, but no increase in cessation rate, 6 weeks after medication had been discontinued.

AB - Background.—Clonidine may be useful in controlling tobacco withdrawal and in facilitating smoking cessation. This study was developed to test the efficacy of transdermal clonidine in promoting smoking cessation. Methods.—We conducted a five-center, double-blind, placebo-controlled, randomized controlled trial of transdermal clonidine in conjunction with a minimal behavioral intervention for smoking cessation. The intervention was based on the American Lung Association’s Freedom From Smoking program. Self report of not smoking was validated with exhaled air carbon monoxide of less than 8 ppm and salivary cotinine of less than 20 ng/mL. Transdermal clonidine therapy began 1 week before the target quit date: 0.1 mg/24 h for the first 4 days increasing to 0.2 mg/24 h for the next 3 days, if the lower dose was tolerated. The highest tolerated dose was then continued for 6 weeks after target quit day. Withdrawal symptoms were measured daily for the first 7 days after target quit day. Results.—A total of 213 patients were enrolled (106 active drug and 107 placebo). During the study, 15.5% of patients had drug therapy discontinued due to adverse effects, 24.5% (26/106) taking active drug vs 8.4% (9/107) receiving placebo. There was a significant reduction in anxiety score from 3.0 to 2.4 (placebo vs active) and irritability score from 2.2 to 1.7 (placebo vs active) during the first week after cessation. There was no reduction in other withdrawal symptoms. The overall 12-week abstinence rate was 33.0% (35/106) in the active drug group vs 34.5% (37/107) in the placebo group (not significant). Conclusions.—This study demonstrated some reduction in early withdrawal symptoms with the use of a clonidine transdermal patch, but no increase in cessation rate, 6 weeks after medication had been discontinued.

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