Clinical trial NCT01208935: Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
Official title: Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tobacco Dependence
Keywords: Randomized
Double blind
double-dummy
placebo-controlled
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2010-09-24
Enrollment: 157
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: We hypothesize that two nicotine replacement delivery systems (patch and gum) are both safe and efficacious for the treatment of adolescent nicotine dependence. Consequently, use of both the patch and gum should be tolerable in this population with only minor adverse side-effects. Secondly, some individuals in both groups (patch, gum) may benefit from either cessation or reduction in smoke exposure, as a result of the distinctly different mechanisms of the two treatments (steady state vs. intermittent delivery of NRT).

A.The primary objectives of this study are:

1. to evaluate the comparative safety of the nicotine transdermal system (21 mg "patch") and the nicotine gum (2 mg and 4 mg), dosed appropriately to pre-treatment levels of smoking, to initiate and sustain smoking cessation and reduction ;
2. to compare compliance levels with the patch and gum;
3. to evaluate the comparative efficacy of the patch and the gum to initiate and sustain smoking cessation and reduction;
4. to compare the rates of biochemically-verified continuous abstinence by using intent-to-treat analysis based on individual subject outcome.

B.The secondary objectives of this study are:

1. to correlate pre-treatment nicotine exposure (saliva cotinine) with withdrawal intensity measured in all groups during treatment and with treatment outcome;
2. to compare biological markers of smoke exposure (expired air CO and saliva thiocyanate) with self-reports of smoking and to correlate them with withdrawal symptomatology and treatment outcome;
3. to obtain smoking topography data (puff volume, velocity of intake, interpuff interval, and puffs per cigarette) on adolescent patterns of smoking as an index of smoking intensity and exposure and to correlate pre-treatment smoking intensity with treatment outcome.

C.The tertiary objectives are:

1. to examine the validity of the use of biochemical markers of smoke exposure (expired air CO and saliva thiocyanate) as potential markers of smoking cessation in adolescents;
2. to compare the relative cotinine exposure of adolescents who are smoking with those who are receiving nicotine replacement who do and do not successfully quit

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: a)Safety will be tabulated as a function of reported and observed adverse side-effects.
measure: 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.
measure: 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.
measure: d) Weight and body mass index (BMI)
measure: e)Cognitive performance tests
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Teen Tobacco Addiction Research Clinic
state: Maryland
Study officials:
affiliation: National Institutes on Drug Abuse IRP/ NIH
name: Eric T. Moolchan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Moolchan ET, Franken FH, Jaszyna-Gasior M. Adolescent nicotine metabolism: ethnoracial differences among dependent smokers. Ethn Dis. 2006 Winter;16(1):239-43.
citation: 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.