Tobacco DependencePhase 2/3NCT01208935
Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
A Phase 2/3 study testing Nicotine Patch and Nicotine Gum in people with Tobacco Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Nicotine Patch and Nicotine Gum
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Aug 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Teen Tobacco Addiction Research Clinic
Baltimore, Maryland, 21224
About this study
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.
Read the 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:
- 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 ;
- to compare compliance levels with the patch and gum;
- to evaluate the comparative efficacy of the patch and the gum to initiate and sustain smoking cessation and reduction;
- 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:
- to correlate pre-treatment nicotine exposure (saliva cotinine) with withdrawal intensity measured in all groups during treatment and with treatment outcome;
- 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;
- 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:
- 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;
- 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
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine Patch, Nicotine Gum
- Keywords
- Randomized, Double blind, double-dummy, placebo-controlled
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Nicotine GumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startAug 1999
- Primary completionJun 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Eric T. Moolchan, M.D., Principal investigator, National Institutes on Drug Abuse IRP/ NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208935
- Sponsor's protocol ID
- NIDA-IRP-322
- Status last verified
- Sep 2010
- First submitted
- 23 Sep 2010
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
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.
PubMed 15805342Aung 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.
PubMed 15135551Zimmerman 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.
PubMed 15475027Moolchan 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.
PubMed 15770886Moolchan 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.
PubMed 15233486Jones 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.
PubMed 15135554Cramer 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.
PubMed 14982721Moolchan 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.
PubMed 15539053Robinson 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.
PubMed 15313503Aung 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.
PubMed 12901450Moolchan 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.
PubMed 12796232Moolchan 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.
PubMed 12039510Moolchan 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.
PubMed 11202758Moolchan 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.
PubMed 10846302Collins 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.
PubMed 16303257
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
- ClinicalTrials.gov ID
- NCT01208935
- Acronym / sponsor ID
- NIDA-IRP-322
- Conditions
- Tobacco Dependence
- Keywords
- Randomized, Double blind, double-dummy, placebo-controlled
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 1999
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 ;
- to compare compliance levels with the patch and gum;
- to evaluate the comparative efficacy of the patch and the gum to initiate and sustain smoking cessation and reduction;
- 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:
- to correlate pre-treatment nicotine exposure (saliva cotinine) with withdrawal intensity measured in all groups during treatment and with treatment outcome;
- 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;
- 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:
- 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;
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Patch | Drug | – |
| Nicotine Gum | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 15805342Moolchan 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: PubMed 15135551Aung 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: PubMed 15475027Zimmerman 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: PubMed 15770886Moolchan 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: PubMed 15233486Moolchan 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: PubMed 15135554Jones 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: PubMed 14982721Cramer 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: PubMed 15539053Moolchan 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: PubMed 15313503Robinson 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: PubMed 12901450Aung 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: PubMed 12796232Moolchan 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: PubMed 12039510Moolchan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric T. Moolchan, M.D. principal investigator
National Institutes on Drug Abuse IRP/ NIH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nicotine Patch and Nicotine Gum in people with Tobacco Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a)Safety will be tabulated as a function of reported and observed adverse side-effects.. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01208935, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.