Smoking CessationPhase 2/3NCT00158158
Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
A Phase 2/3 study testing Smoking Reduction 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 smoke. 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 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- Smoking Reduction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2007
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Has smoked at least 5 cigarettes a day for at least 6 months
- Does not regularly use other tobacco products
- Motivated to quit smoking
- Not currently using medications to quit smoking
- Willing to use an effective form of contraception throughout the study
Who cannot join
- Informed that nicotine replacement therapy is medically inadvisable
- Diagnosed with a psychiatric disorder within 3 months prior to enrollment
- Currently taking an unstable dose of psychoactive medications
- Currently taking medications that may react with a nicotine patch
- History of alcohol or drug abuse within 3 months prior to enrollment
- 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 smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will examine whether reducing smoking will facilitate quitting smoking in adolescents who have unsuccessfully attempted to quit smoking
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, including several types of cancer. This study will examine whether reducing smoking will facilitate smoking cessation in adolescents who have unsuccessfully attempted to quit smoking. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation and self-efficacy to quit.
Participants in this open-label study will undergo 2 weeks of baseline measurements, followed by 2 weeks of smoking cessation treatment. Treatment will involve a nicotine patch, for those who are eligible, and a standardized behavioral intervention aimed at supporting smoking cessation. Those who are ineligible to receive a nicotine patch will only receive the standardized behavioral intervention. Participants who quit smoking during the first phase of treatment will continue to receive the nicotine patches and/or the standardized behavioral intervention. Those who are still smoking after the first treatment will be randomly assigned to one of two conditions and will continue to use nicotine patches for 4 weeks. Group 1 will receive standardized behavioral therapy and will set a specific quit date. Group 2 will be encouraged to decrease smoking by 50% the first week and 75% the second week. During Week 3, participants will be encouraged to completely quit smoking. Study visits will occur weekly, at which time nicotine patches will be dispensed, standardized behavioral therapy will be provided, and standard physiological measurements will be taken. A urine sample will also be collected. Follow-up visits will be held 2 weeks, 3 weeks, and 6 months following completion of the study.
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Being tested
- Usual Care, Smoking Reduction
- 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.
Usual CareDrug
Also called Nicoderm used for initial quit attempt.
If unable to quit at quit date, offered usual care to set another quit date.
Smoking ReductionOther
Also called Nicotine patch used for initial cessation and smoking reduction.
If unable to quit smoking, reduce smoking rate prior to quit date.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Usual care Receives: Drug: Usual Care |
| 2 | Experimental | Reduction in smoking Receives: Other: Smoking Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Rate; measured throughout study
Measured: 26 weeks
Extent of reduction in smoking; measured at Week 6
Measured: 6, 12 and 26 weeks
Secondary outcomes (2)
Degree of motivation to quit; measured at Week 6
Measured: 6, 12 and 26 weeks
Extent of exposure to cigarette toxicity; measured throughout study
Measured: 6, 12 and 26 weeks
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 startSep 2005
- Primary completionSep 2007
- Study completionSep 2007
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT00158158
- Sponsor's protocol ID
- NIDA-14538-2
- Other IDs
- R01-14538-2, 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
- NCT00158158
- Acronym / sponsor ID
- NIDA-14538-2
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Keywords
- smoking addiction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Sep 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (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 smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will examine whether reducing smoking will facilitate quitting smoking in adolescents who have unsuccessfully attempted to quit smoking
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, including several types of cancer. This study will examine whether reducing smoking will facilitate smoking cessation in adolescents who have unsuccessfully attempted to quit smoking. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation and self-efficacy to quit.
Participants in this open-label study will undergo 2 weeks of baseline measurements, followed by 2 weeks of smoking cessation treatment. Treatment will involve a nicotine patch, for those who are eligible, and a standardized behavioral intervention aimed at supporting smoking cessation. Those who are ineligible to receive a nicotine patch will only receive the standardized behavioral intervention. Participants who quit smoking during the first phase of treatment will continue to receive the nicotine patches and/or the standardized behavioral intervention. Those who are still smoking after the first treatment will be randomly assigned to one of two conditions and will continue to use nicotine patches for 4 weeks. Group 1 will receive standardized behavioral therapy and will set a specific quit date. Group 2 will be encouraged to decrease smoking by 50% the first week and 75% the second week. During Week 3, participants will be encouraged to completely quit smoking. Study visits will occur weekly, at which time nicotine patches will be dispensed, standardized behavioral therapy will be provided, and standard physiological measurements will be taken. A urine sample will also be collected. Follow-up visits will be held 2 weeks, 3 weeks, and 6 months following completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Usual CareUsual care |
| 2 | Experimental | Other: Smoking ReductionReduction in smoking |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Has smoked at least 5 cigarettes a day for at least 6 months
- Does not regularly use other tobacco products
- Motivated to quit smoking
- Not currently using medications to quit smoking
- Willing to use an effective form of contraception throughout the study
Key exclusion criteria (6 listed)
- Informed that nicotine replacement therapy is medically inadvisable
- Diagnosed with a psychiatric disorder within 3 months prior to enrollment
- Currently taking an unstable dose of psychoactive medications
- Currently taking medications that may react with a nicotine patch
- History of alcohol or drug abuse within 3 months prior to enrollment
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 |
|---|---|---|
| Usual CareAlso: Nicoderm used for initial quit attempt.If unable to quit at quit date, offered usual care to set another quit date. | Drug | 1 |
| Smoking ReductionAlso: Nicotine patch used for initial cessation and smoking reduction.If unable to quit smoking, reduce smoking rate prior to quit date. | Other | 2 |
Primary outcome
Quit Rate; measured throughout study
Time frame: 26 weeks
Extent of reduction in smoking; measured at Week 6
Time frame: 6, 12 and 26 weeks
2 secondary outcomes
Degree of motivation to quit; measured at Week 6
Time frame: 6, 12 and 26 weeks
Extent of exposure to cigarette toxicity; measured throughout study
Time frame: 6, 12 and 26 weeks
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 2/3 study testing Smoking Reduction 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 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?
Quit Rate; measured throughout study (time frame: 26 weeks). The study lists 2 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 10 Jan 2017.