Smoking CessationPhase 2NCT00218140
Effectiveness of the Nicotine Patch in Suppressing Nicotine Withdrawal Symptoms in Women Versus Men - 1
A Phase 2 study testing nicotine transdermal system 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
Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- nicotine transdermal system
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 2005
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smokes at least 15 cigarettes a day for at least 2 years prior to enrollment
- Has an afternoon carbon monoxide level of at least 15 ppm
- Agree to use an effective form of contraception for the duration of the study
Who cannot join
- History of chronic health problems
- History of psychiatric conditions
- History of or active cardiovascular disease
- History of or active high or low blood pressure
- History of or active seizure condition
- History of or active peptic ulcers
Show all 9Show fewer
- History of or active diabetes
- Pregnant
- Score of greater than 17 on the Beck Depression Inventory
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nicotine Patch in Men and Women
Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy.
Read the detailed description
Smoking can cause a variety of cancers, cardiovascular disorders, and other health problems. Quitting smoking greatly decreases one's risk for these problems. Studies have shown, however, that quitting smoking is more difficult for women than men. Despite that knowledge, little research has been done to try to understand the mechanistic differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by physical and psychological gender differences in the withdrawal suppression induced by nicotine replacement therapy.
Participants in this double-blind study will attend 4 treatment sessions, each approximately 6.5 hours long and each corresponding to one of four transdermal nicotine replacement patch doses (0, 7, 21, or 42 mg). Sessions will be separated by at least 48 hours to avoid carryover effects. Immediately following arrival at each session, participants' expired air carbon monoxide (CO) levels will be measured to verify that the participant has not smoked for at least 8 hours prior to the visit. If the CO level meets the necessary criteria to proceed, a baseline blood sample will be obtained, followed by additional blood samples every 30 minutes. Baseline nicotine withdrawal levels will be assessed using questionnaires. Computerized recordings of physiological responses will also commence and will continue throughout the session. These response measures will include heart rate, percent oxygen saturation, skin temperature, systolic and diastolic blood pressure, and mean arterial pressure. Upon completion of baseline measures, participants will receive a randomly assigned dose of nicotine replacement therapy, in the form of three patches placed on the participants' back. The patches will be removed after 6 hours and the participant will be assessed for any residual effects from the medication.
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Being tested
- nicotine transdermal system
- Keywords
- tobacco
- 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 transdermal systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological measures
Tobacco withdrawal
Behavioral accuracy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study completionApr 2005
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
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas Eissenberg, Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218140
- Sponsor's protocol ID
- NIDA-11082-1
- Other IDs
- R01-11082-1, DPMC
- Status last verified
- Oct 2016
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
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
- Effects of Nicotine Patch in Men and Women
- ClinicalTrials.gov ID
- NCT00218140
- Acronym / sponsor ID
- NIDA-11082-1
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Keywords
- tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study completion
- Apr 2005
- First posted
- 22 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.
Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy.
Detailed description
Smoking can cause a variety of cancers, cardiovascular disorders, and other health problems. Quitting smoking greatly decreases one's risk for these problems. Studies have shown, however, that quitting smoking is more difficult for women than men. Despite that knowledge, little research has been done to try to understand the mechanistic differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by physical and psychological gender differences in the withdrawal suppression induced by nicotine replacement therapy.
Participants in this double-blind study will attend 4 treatment sessions, each approximately 6.5 hours long and each corresponding to one of four transdermal nicotine replacement patch doses (0, 7, 21, or 42 mg). Sessions will be separated by at least 48 hours to avoid carryover effects. Immediately following arrival at each session, participants' expired air carbon monoxide (CO) levels will be measured to verify that the participant has not smoked for at least 8 hours prior to the visit. If the CO level meets the necessary criteria to proceed, a baseline blood sample will be obtained, followed by additional blood samples every 30 minutes. Baseline nicotine withdrawal levels will be assessed using questionnaires. Computerized recordings of physiological responses will also commence and will continue throughout the session. These response measures will include heart rate, percent oxygen saturation, skin temperature, systolic and diastolic blood pressure, and mean arterial pressure. Upon completion of baseline measures, participants will receive a randomly assigned dose of nicotine replacement therapy, in the form of three patches placed on the participants' back. The patches will be removed after 6 hours and the participant will be assessed for any residual effects from the medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Smokes at least 15 cigarettes a day for at least 2 years prior to enrollment
- Has an afternoon carbon monoxide level of at least 15 ppm
- Agree to use an effective form of contraception for the duration of the study
Key exclusion criteria (9 listed)
- History of chronic health problems
- History of psychiatric conditions
- History of or active cardiovascular disease
- History of or active high or low blood pressure
- History of or active seizure condition
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 transdermal system | Drug | – |
Primary outcome
Physiological measures
Tobacco withdrawal
Behavioral accuracy
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.
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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.
Thomas Eissenberg, Ph.D. principal investigator
Virginia Commonwealth University
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 transdermal system 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 3 inclusion and 9 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 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?
Physiological measures. 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 12 Jan 2017.