SmokingNCT00631020
Youth Smoking Cessation: Therapy +/- "The Patch"
A study testing CBME and Optional NRT in people with Smoking, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Reducing tobacco use by adolescents is a national health priority. In recent polls, most adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative… Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- CBME and Optional NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must meet all of the following inclusion criteria:
- age of 14-21 years, inclusive
- regular cigarette smoking at least five times a day in the month before entry into the study and initiation of smoking at least 6 months before entry
- A score of 35 or greater on the Cigarette Dependence Scale-12
- youth provide informed assent (for youth <18 yr) or consent (for youth ≥18 yr) and parents provide informed consent to participate in the project
- documented approval to participate from the participant's treating physician for participants currently receiving treatment for a serious medical or psychiatric condition
Show all 9Show fewer
- current contact information (address, telephone number), which is needed for follow-up
- able to complete study assessments and participate in the intervention (e.g., lives < 1 hr. away from the site, has family to participate in the intervention, does not have mental retardation)
- youth or primary caregivers speak English or Spanish
Who cannot join
- Participants must meet none of the following exclusion criteria in order to be eligible to receive optional nicotine replacement:
- smoke less than 5 cigarettes per day
- have serious cardiovascular disease, including uncontrolled hypertension, coronary artery disease, serious cardiac arrhythmias, vasospastic disease, or angina, due to potential cardiovascular effects of nicotine, as determined via the baseline medical history and physical exam
- have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
- have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
- have a known allergy to nicotine or any component of the nicotine patches
- be receiving treatment with adenosine or bupropion due to potential drug-drug interactions
- be pregnant or sexually active and not using reliable birth control methods consistently (for females)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Efficacy of Cognitive-behavioral Motivational Enhancement +/- Nicotine Replacement Therapy for Adolescents
Reducing tobacco use by adolescents is a national health priority. In recent polls, most adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences. Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking. This project will address gaps in the scientific treatment literature. The goal of this project is to develop a tailored, practical, and efficacious smoking cessation intervention. Combined with other efforts in the field, this work can provide an initial guide to an evidence-based treatment for smoking cessation in youth.
In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. Such an individualized approach for adolescent smoking cessation will be informed by further investigation of the relationships between outcomes in this trial. To serve these goals, we propose the following program:
Read more
Youths who smoke regularly will receive a 6 week intervention using "cognitive-behavioral motivational enhancement" (CBME) supplemented by nicotine replacement therapy (NRT), if youth and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day in order to qualify for nicotine replacement therapy. This approach is consistent with treatment guidelines for smoking cessation (Fiore 2000).
Compared with participants who fail to achieve smoking cessation, those who successfully achieve smoking abstinence during intervention, will have lower baseline rates of comorbid ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes towards smoking, fewer friends who smoke, and fewer family members who smoke. The investigators predict that the intervention will help youth to quit smoking and will examine predictions of successful quitting.
Read the detailed description
Tobacco use is the leading preventable cause of death in the United States, and current estimates project that 6.4 million of our nation's youth will die prematurely from a smoking-related disease (Fellows et al., 2002). Extant data suggest that three of every five adolescent smokers are nicotine-dependent, and that some subgroups of adolescents are at higher risk for dependence (e.g., daily or heavy smokers, incarcerated youth, youth in vocational schools, depressed youth, youth with Attention Deficit Hyperactivity Disorder (ADHD)). Adolescent tobacco smoking increases risk for a wide range of negative health consequences (Abrantes et al., 2005; Anda et al., 1990; Biederman et al., 2006; Escobedo et al., 1998; Kandel et al., 1986; Kollins et al., 2005; Wilens \& Dodson 2004). For example, smoking-related cancer risk is increased with early age of initiating smoking and longer time of smoking, underscoring the importance of addressing this health risk behavior in youth (Centers for Disease Control and Prevention, 1994).
Reducing tobacco use by adolescents is a national health priority (see Healthy People 2010, Objective, 27.2 (Office of Disease Prevention and Health Promotion 2000)). Approximately 4% of 8th graders, 7.5% of 10th graders, and 13.6% of 12th graders smoke daily and almost half of these youths smoke ≥ half a pack per day (Johnston \& O'Coner 2005). In recent polls, most adolescent smokers reported having tried unsuccessfully to quit (Grimshaw et al., 2003; Hollis et al., 2003). Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences (Anda et al., 1990; Escobedo et al., 1998; Kandel \& Davies 1986). Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking (Backinger et al., 2003). This project will address gaps in the scientific treatment literature.
In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. In order to optimize the aim for personalized treatment we will include genetic testing. For some smoking cessation treatments, evidence has begun to accumulate that the inter-individual variability in response to treatment benefits and side effects may be influenced by inheritance. In the smoking cessation treatment literature, some observations have already been made suggesting that common gene variants may be associated with different treatment outcomes. The association between depression and smoking has led to interest in whether the short allele of the serotonin transporter gene may be associated with increased vulnerability to smoking and nicotine dependence, although to our knowledge this has yet to be demonstrated (Brody, et al. 2005). Such findings suggest that individual vulnerability to the reinforcing effects of smoking, and most important to this study differences in quitting success, could be partially predicted by individual genotype. Additionally, motivational and psychosocial factors have also been identified as likely predictors of treatment response. We are seeking predictors that would allow us to reach the ultimate objective: to contribute to an algorithm to better match youth and effective smoking cessation treatment.
Specific Aims of the study are as follows:
- To evaluate an intervention for adolescent smoking cessation.
- To examine moderators and mediators of successful smoking cessation.
- Conditions
- Smoking
- Being tested
- CBME, Optional NRT
- Keywords
- Youth, Smoking, Tobacco, Adolescent, Dependence, Teen smoking, Smoking and youth, Youth and tobacco
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBMEBehavioural
6 weeks of once a week one-on-one CBME
Optional NRTDrug
NicoDerm CQ nicotine transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| CBME +/- NRT | Experimental | 6 weeks CBME with optional 4 weeks NRT Receives: Behavioral: CBME; Drug: Optional NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of Nicotine Replacement Therapy
Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.
Measured: week 2
Retention in Trial
Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)
Measured: week 6
7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)
The primary index of smoking behavior will be subject's self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm.
Measured: week 6, 12, 16 and 24
Secondary outcomes (3)
Changes in Tobacco Withdrawal Symptoms Compared to Baseline
Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined.
Measured: Weeks 6, 12, 16 and 24
Change in Tobacco Dependence Compared to Baseline
Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured.
Measured: Weeks 6, 12, 16 and 24
Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline
Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point.
Measured: Weeks 6, 12, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris USA
- Responsible party
- Principal investigator, Steve Shoptaw, University of California, Los Angeles
- Investigators
- Steven Shoptaw, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631020
- Sponsor's protocol ID
- PM 20063287
- Status last verified
- Apr 2015
- First submitted
- 27 Feb 2008
- Last updated
- 22 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy of Cognitive-behavioral Motivational Enhancement +/- Nicotine Replacement Therapy for Adolescents
- ClinicalTrials.gov ID
- NCT00631020
- Acronym / sponsor ID
- PM 20063287
- Conditions
- Smoking
- Keywords
- Youth, Smoking, Tobacco, Adolescent, Dependence, Teen smoking, Smoking and youth, Youth and tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Philip Morris USA
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 22 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing tobacco use by adolescents is a national health priority. In recent polls, most adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences. Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking. This project will address gaps in the scientific treatment literature. The goal of this project is to develop a tailored, practical, and efficacious smoking cessation intervention. Combined with other efforts in the field, this work can provide an initial guide to an evidence-based treatment for smoking cessation in youth.
In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. Such an individualized approach for adolescent smoking cessation will be informed by further investigation of the relationships between outcomes in this trial. To serve these goals, we propose the following program:
Youths who smoke regularly will receive a 6 week intervention using "cognitive-behavioral motivational enhancement" (CBME) supplemented by nicotine replacement therapy (NRT), if youth and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day in order to qualify for nicotine replacement therapy. This approach is consistent with treatment guidelines for smoking cessation (Fiore 2000).
Compared with participants who fail to achieve smoking cessation, those who successfully achieve smoking abstinence during intervention, will have lower baseline rates of comorbid ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes towards smoking, fewer friends who smoke, and fewer family members who smoke. The investigators predict that the intervention will help youth to quit smoking and will examine predictions of successful quitting.
Detailed description
Tobacco use is the leading preventable cause of death in the United States, and current estimates project that 6.4 million of our nation's youth will die prematurely from a smoking-related disease (Fellows et al., 2002). Extant data suggest that three of every five adolescent smokers are nicotine-dependent, and that some subgroups of adolescents are at higher risk for dependence (e.g., daily or heavy smokers, incarcerated youth, youth in vocational schools, depressed youth, youth with Attention Deficit Hyperactivity Disorder (ADHD)). Adolescent tobacco smoking increases risk for a wide range of negative health consequences (Abrantes et al., 2005; Anda et al., 1990; Biederman et al., 2006; Escobedo et al., 1998; Kandel et al., 1986; Kollins et al., 2005; Wilens \& Dodson 2004). For example, smoking-related cancer risk is increased with early age of initiating smoking and longer time of smoking, underscoring the importance of addressing this health risk behavior in youth (Centers for Disease Control and Prevention, 1994).
Reducing tobacco use by adolescents is a national health priority (see Healthy People 2010, Objective, 27.2 (Office of Disease Prevention and Health Promotion 2000)). Approximately 4% of 8th graders, 7.5% of 10th graders, and 13.6% of 12th graders smoke daily and almost half of these youths smoke ≥ half a pack per day (Johnston \& O'Coner 2005). In recent polls, most adolescent smokers reported having tried unsuccessfully to quit (Grimshaw et al., 2003; Hollis et al., 2003). Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences (Anda et al., 1990; Escobedo et al., 1998; Kandel \& Davies 1986). Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking (Backinger et al., 2003). This project will address gaps in the scientific treatment literature.
In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. In order to optimize the aim for personalized treatment we will include genetic testing. For some smoking cessation treatments, evidence has begun to accumulate that the inter-individual variability in response to treatment benefits and side effects may be influenced by inheritance. In the smoking cessation treatment literature, some observations have already been made suggesting that common gene variants may be associated with different treatment outcomes. The association between depression and smoking has led to interest in whether the short allele of the serotonin transporter gene may be associated with increased vulnerability to smoking and nicotine dependence, although to our knowledge this has yet to be demonstrated (Brody, et al. 2005). Such findings suggest that individual vulnerability to the reinforcing effects of smoking, and most important to this study differences in quitting success, could be partially predicted by individual genotype. Additionally, motivational and psychosocial factors have also been identified as likely predictors of treatment response. We are seeking predictors that would allow us to reach the ultimate objective: to contribute to an algorithm to better match youth and effective smoking cessation treatment.
Specific Aims of the study are as follows:
- To evaluate an intervention for adolescent smoking cessation.
- To examine moderators and mediators of successful smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBME +/- NRT | Experimental | Behavioral: CBME, Drug: Optional NRT6 weeks CBME with optional 4 weeks NRT |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- age of 14-21 years, inclusive
- regular cigarette smoking at least five times a day in the month before entry into the study and initiation of smoking at least 6 months before entry
- A score of 35 or greater on the Cigarette Dependence Scale-12
- youth provide informed assent (for youth <18 yr) or consent (for youth ≥18 yr) and parents provide informed consent to participate in the project
- documented approval to participate from the participant's treating physician for participants currently receiving treatment for a serious medical or psychiatric condition
Key exclusion criteria (8 listed)
- Participants must meet none of the following exclusion criteria in order to be eligible to receive optional nicotine replacement:
- smoke less than 5 cigarettes per day
- have serious cardiovascular disease, including uncontrolled hypertension, coronary artery disease, serious cardiac arrhythmias, vasospastic disease, or angina, due to potential cardiovascular effects of nicotine, as determined via the baseline medical history and physical exam
- have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
- have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
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 |
|---|---|---|
| CBME6 weeks of once a week one-on-one CBME | Behavioural | CBME +/- NRT |
| Optional NRTNicoDerm CQ nicotine transdermal patch | Drug | CBME +/- NRT |
Primary outcome
Acceptance of Nicotine Replacement Therapy
Time frame: week 2
Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.
Retention in Trial
Time frame: week 6
Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)
7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)
Time frame: week 6, 12, 16 and 24
The primary index of smoking behavior will be subject's self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm.
3 secondary outcomes
Changes in Tobacco Withdrawal Symptoms Compared to Baseline
Time frame: Weeks 6, 12, 16 and 24
Change in Tobacco Dependence Compared to Baseline
Time frame: Weeks 6, 12, 16 and 24
Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline
Time frame: Weeks 6, 12, 16 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven Shoptaw, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBME and Optional NRT in people with Smoking, run by University of California, Los Angeles 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 9 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 22 Apr 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptance of Nicotine Replacement Therapy (time frame: week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2015.