drugset / Trial / NCT01208935
Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to test the safety, tolerability, compliance and efficacy of two different forms of nicotine replacement therapy (NRT) (the nicotine transdermal patch and the nicotine gum) in a nicotine-dependent adolescent population.
Timeline
- Start
- 1999-08
- Primary completion
- 2004-06
- Completion
- 2004-08
Publications
- Background Moolchan ET, Robinson ML, Ernst M, Cadet JL, Pickworth WB, Heishman SJ, Schroeder JR. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction. Pediatrics. 2005 Apr;115(4):e407-14. doi: 10.1542/peds.2004-1894.
- Background Aung AT, Pickworth WB, Moolchan ET. History of marijuana use and tobacco smoking topography in tobacco-dependent adolescents. Addict Behav. 2004 Jun;29(4):699-706. doi: 10.1016/j.addbeh.2004.02.012.
- Background Zimmerman DM, Sehnert SS, Epstein DH, Pickworth WB, Robinson ML, Moolchan ET. Smoking topography and trajectory of asthmatic adolescents requesting cessation treatment. Prev Med. 2004 Nov;39(5):940-2. doi: 10.1016/j.ypmed.2004.03.032.
- Background Moolchan ET, Zimmerman D, Sehnert SS, Zimmerman D, Huestis MA, Epstein DH. Recent marijuana blunt smoking impacts carbon monoxide as a measure of adolescent tobacco abstinence. Subst Use Misuse. 2005;40(2):231-40. doi: 10.1081/ja-200048461.
- Background Moolchan ET, Hudson DL, Schroeder JR, Sehnert SS. Heart rate and blood pressure responses to tobacco smoking among African-American adolescents. J Natl Med Assoc. 2004 Jun;96(6):767-71.
- Background Jones DN, Schroeder JR, Moolchan ET. Time spent with friends who smoke and quit attempts among teen smokers. Addict Behav. 2004 Jun;29(4):723-9. doi: 10.1016/j.addbeh.2004.02.026.
- Background Cramer K, Tuokko HA, Mateer CA, Hultsch DF. Measuring awareness of financial skills: reliability and validity of a new measure. Aging Ment Health. 2004 Mar;8(2):161-71. doi: 10.1080/13607860410001649581.
- Background Moolchan ET, Schroeder JR. Quit attempts among African American teenage smokers seeking treatment: gender differences. Prev Med. 2004 Dec;39(6):1180-6. doi: 10.1016/j.ypmed.2004.04.050.
- Background Robinson ML, Berlin I, Moolchan ET. Tobacco smoking trajectory and associated ethnic differences among adolescent smokers seeking cessation treatment. J Adolesc Health. 2004 Sep;35(3):217-24. doi: 10.1016/j.jadohealth.2003.10.005.
- Background Aung AT, Hickman NJ 3rd, Moolchan ET. Health and performance related reasons for wanting to quit: gender differences among teen smokers. Subst Use Misuse. 2003 Jun;38(8):1095-107. doi: 10.1081/ja-120017652.
- Background Moolchan ET, Berlin I, Robinson ML, Cadet JL. Characteristics of African American teenage smokers who request cessation treatment: implications for addressing health disparities. Arch Pediatr Adolesc Med. 2003 Jun;157(6):533-8. doi: 10.1001/archpedi.157.6.533.
- Background Moolchan ET, Mermelstein R. Research on tobacco use among teenagers: ethical challenges. J Adolesc Health. 2002 Jun;30(6):409-17. doi: 10.1016/s1054-139x(02)00365-8.
- Background Moolchan ET, Berlin I, Robinson ML, Cadet JL. African-American teen smokers: issues to consider for cessation treatment. J Natl Med Assoc. 2000 Dec;92(12):558-62.
- Background Moolchan ET, Ernst M, Henningfield JE. A review of tobacco smoking in adolescents: treatment implications. J Am Acad Child Adolesc Psychiatry. 2000 Jun;39(6):682-93. doi: 10.1097/00004583-200006000-00006.
- Background Collins CC, Moolchan ET. Shorter time to first cigarette of the day in menthol adolescent cigarette smokers. Addict Behav. 2006 Aug;31(8):1460-4. doi: 10.1016/j.addbeh.2005.10.001. Epub 2005 Nov 21.
- Background Franken FH, Pickworth WB, Epstein DH, Moolchan ET. Smoking rates and topography predict adolescent smoking cessation following treatment with nicotine replacement therapy. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):154-7. doi: 10.1158/1055-9965.EPI-05-0167.
- Background Robinson ML, Schroeder JR, Moolchan ET. Adolescent smokers screened for a nicotine replacement treatment trial: correlates of eligibility and enrollment. Nicotine Tob Res. 2006 Jun;8(3):447-54. doi: 10.1080/14622200600670413.
- Background Moolchan ET, Franken FH, Jaszyna-Gasior M. Adolescent nicotine metabolism: ethnoracial differences among dependent smokers. Ethn Dis. 2006 Winter;16(1):239-43.
- Background Moolchan ET, Aung AT, Henningfield JE. Treatment of adolescent tobacco smokers: issues and opportunities for exposure reduction approaches. Drug Alcohol Depend. 2003 Jun 5;70(3):223-32. doi: 10.1016/s0376-8716(03)00012-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 2 mg | — |
| Subject | Nicotine | Unknown | 4 mg | — |
| Subject | Nicotine | Unknown | 21 mg | Other |