Smoking CessationPhase 2NCT00158171
Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1
A Phase 2 study testing Nicotine Replacement Therapies, Nicotine patch and Folic Acid in people with Smoking Cessation and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- Nicotine Replacement Therapies, Nicotine patch and Folic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to May 2004
- Phase
- Phase 2
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- At least 6 months of daily cigarette smoking
- No use of other tobacco products
- Motivated to reduce or quit smoking
- Not currently using medications to quit smoking
- Agree to use an effective form of contraception throughout the study
Who cannot join
- People for whom use of nicotine replacement therapy or bupropion is medically inadvisable
- History of alcohol or drug abuse within 6 months of enrollment
- History of emotional problems (as assessed by the Adolescent Symptoms Inventory) within 6 months prior to enrollment
- Currently on an unstable dose of psychoactive medications
- Currently taking medications that may react with one of the treatment medications
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Interventions for Tobacco Dependent Adolescents
Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.
Read the detailed description
Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation to quit.
This open-label study will last a total of 6 weeks. Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior. Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits. At Week 3, participants will be randomly assigned to receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4, 5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of cigarettes a participant smoked during baseline, will be dispensed weekly. Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily. During treatment, study visits will occur once weekly. At each study visit, all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction. Smoking habits and vital signs will be assessed and the effects of the treatments will be determined. There will be one follow-up visit 3 months post-intervention, at which time smoking status will be assessed.
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Being tested
- Nicotine Replacement Therapies, Nicotine patch, Folic Acid
- Keywords
- smoking addiction
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapiesDrug
Also called Nicorette
Nicotine gum 2 \& 4 mg dependent on baseline smoking rate
Nicotine patchDrug
Also called Nicoderm
21, 14 or 7 mg patch dependent on baseline smoking rate
Folic AcidDietary supplement
400 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nicotine patch Receives: Drug: Nicotine Replacement Therapies |
| 2 | Experimental | Nicotine gum Receives: Drug: Nicotine patch |
| 3 | Placebo comparator | Folic acid Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in tobacco toxicant exposure
Measured: Weeks 2, 5 and 17
Secondary outcomes (3)
Motivation and self-efficacy to quit; measured at Weeks 5 and 17
Measured: Weeks 5 and 17
Reduction in cigarettes per day
Measured: Weeks 5 and 17
Smoking cessation
Measured: Weeks 5 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dorothy Hatsukami, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158171
- Sponsor's protocol ID
- NIDA-14538-1
- Other IDs
- R01-14538-1, DPMC
- Status last verified
- Oct 2016
- First submitted
- 8 Sep 2005
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Tobacco Dependent Adolescents
- ClinicalTrials.gov ID
- NCT00158171
- Acronym / sponsor ID
- NIDA-14538-1
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Keywords
- smoking addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2002
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 12 Sep 2005 (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.
Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.
Detailed description
Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation to quit.
This open-label study will last a total of 6 weeks. Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior. Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits. At Week 3, participants will be randomly assigned to receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4, 5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of cigarettes a participant smoked during baseline, will be dispensed weekly. Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily. During treatment, study visits will occur once weekly. At each study visit, all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction. Smoking habits and vital signs will be assessed and the effects of the treatments will be determined. There will be one follow-up visit 3 months post-intervention, at which time smoking status will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nicotine Replacement TherapiesNicotine patch |
| 2 | Experimental | Drug: Nicotine patchNicotine gum |
| 3 | Placebo comparator | Dietary Supplement: Folic AcidFolic acid |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- At least 6 months of daily cigarette smoking
- No use of other tobacco products
- Motivated to reduce or quit smoking
- Not currently using medications to quit smoking
- Agree to use an effective form of contraception throughout the study
Key exclusion criteria (6 listed)
- People for whom use of nicotine replacement therapy or bupropion is medically inadvisable
- History of alcohol or drug abuse within 6 months of enrollment
- History of emotional problems (as assessed by the Adolescent Symptoms Inventory) within 6 months prior to enrollment
- Currently on an unstable dose of psychoactive medications
- Currently taking medications that may react with one of the treatment medications
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 Replacement TherapiesAlso: NicoretteNicotine gum 2 \& 4 mg dependent on baseline smoking rate | Drug | 1 |
| Nicotine patchAlso: Nicoderm21, 14 or 7 mg patch dependent on baseline smoking rate | Drug | 2 |
| Folic Acid400 mg | Dietary supplement | 3 |
Primary outcome
Reduction in tobacco toxicant exposure
Time frame: Weeks 2, 5 and 17
3 secondary outcomes
Motivation and self-efficacy to quit; measured at Weeks 5 and 17
Time frame: Weeks 5 and 17
Reduction in cigarettes per day
Time frame: Weeks 5 and 17
Smoking cessation
Time frame: Weeks 5 and 17
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 10 Jan 2017.
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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.
Dorothy Hatsukami, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine Replacement Therapies, Nicotine patch and Folic Acid in people with Smoking Cessation and Tobacco Use Disorder, 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 5 inclusion and 6 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 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Reduction in tobacco toxicant exposure (time frame: Weeks 2, 5 and 17). 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 10 Jan 2017.