Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence

NCT01208935 | Completed Phase 2

• 1 other identifier: NIDA-IRP-322
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Dependence

Keywords

Randomized; Double blind; double-dummy; placebo-controlled

Outcome Measures

Primary Outcomes (5)

• a)Safety will be tabulated as a function of reported and observed adverse side-effects.

• b)Tolerability and Compliance by attendance at visits, completeness of smoking cessation diaries, saliva cotinine, and correlations of biologic markers (expired air CO and saliva thiocyanate) with smoking cessation diaries.

• c) Efficacy by Minnesota Withdrawal scale, craving visual analog scales and Questionnaire of Smoking Urges, smoking abstinence/reduction (as per self-reported data in smoking cessation diaries), expired air CO and saliva thiocyanate.

• d) Weight and body mass index (BMI)

• e)Cognitive performance tests

Interventions

Nicotine Patch DRUG

Nicotine Gum DRUG

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• History of smoking 11 or more cigarettes per day (cpd) for at least one year
• Fagerström Test for Nicotine Dependence score of 5 and above
• General good health as verified by history, physical, psychiatric examination and screening laboratory tests

You may not qualify if:

• History of cardiac disease
• Active dependence on any drug other than nicotine (as assessed by the DUSI)
• Current or past severe psychiatric disorders as per the Diagnostic Interview for Children and Adolescents (DICA-A)
• Current use of tobacco or nicotine containing products other than cigarettes
• Previous use of any nicotine transdermal patch or nicotine gum
• Presence or history of severe skin allergies or dermatoses
• Pregnancy or lactation
• Active oral, dental or jaw mobility problems

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Teen Tobacco Addiction Research Clinic

Baltimore, Maryland, 21224, United States

Location

Related Publications (19)

• 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.

  PMID: 15805342 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.

  PMID: 15135551 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.

  PMID: 15475027 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.

  PMID: 15770886 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.

  PMID: 15233486 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.

  PMID: 15135554 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.

  PMID: 14982721 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.

  PMID: 15539053 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.

  PMID: 15313503 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.

  PMID: 12901450 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.

  PMID: 12796232 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.

  PMID: 12039510 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.

  PMID: 11202758 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.

  PMID: 10846302 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.

  PMID: 16303257 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.

  PMID: 16434603 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.

  PMID: 16801302 BACKGROUND

• Moolchan ET, Franken FH, Jaszyna-Gasior M. Adolescent nicotine metabolism: ethnoracial differences among dependent smokers. Ethn Dis. 2006 Winter;16(1):239-43.

  PMID: 16599377 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.

  PMID: 12757960 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eric T. Moolchan, M.D.

  National Institutes on Drug Abuse IRP/ NIH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: August 1, 1999
• Primary Completion: June 1, 2004
• Study Completion: August 1, 2004
• Last Updated: January 12, 2017

Record last verified: 2010-09

Locations

US (1)