- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01989923
Smoking Cessation in Women With Gynecological Conditions
Immediate Smoking Cessation for Patients at Risk for Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer - A Feasibility Study Comparing Nicotine Replacement Therapy With the Electronic Nicotine Delivery System.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- Smokers (defined as those who have smoked at least daily for the last year and who have smoked greater than or equal to 10 or more combustible cigarettes per day during the last year.
- Patients with diagnoses of Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer
- Ages 18-65 years
Exclusion Criteria:
- Patients unwilling to commit to a 6-week intervention that may include either NRT or ENDS.
- Patients with previous diagnoses of or treatment for cancer - with the exception of non-melanoma skin cancer.
- Presence of any known stroke, heart disease, heart attack, or irregular heart beat.
- Pregnancy and lactation.
- Plan to continue to use other nicotine in addition to the products supplied by the study. These would include: chewing tobacco, snuff, an additional nicotine patch or other nicotine containing products.
- High blood pressure, not well controlled with medication.
- Patients using a non-nicotine "smoking cessation medication."
- Patients taking a prescription medicine for depression or asthma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nicotine replacement therapy
Women in this arm of the study will receive 24-hour Nicotine Patches - either 21 mg patches (for 1 pack per day smokers), or 14 mg patches (for 1/2 pack per day smokers) smokers). Patients will use one patch per day for 6 weeks for a total of 42 patches. Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study. This will allow for a lower strength of nicotine as each woman continues with smoking cessation. Women will also receive nicotine gum or lozenges (subject choice)- these will be 2 mg pieces of nicotine gum or lozenge (approximately 210 pieces). This will account for using 8-10 per day at the beginning of the study and tapering to 2-3 pieces per day by the end of the study. |
Patients will use one patch per day for 6 weeks for a total of 42 patches - they will receive 7 the first visit and then the additional 35 at the second visit.
Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study.
This will allow for a lower strength of nicotine as each woman continues with smoking cessation.
Other Names:
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Active Comparator: Electronic Cigarettes
Women in this arm of the study will receive one "Blu Cig" Electronic Nicotine Delivery Device (E-cigarette) along with 2 electronic cigarette batteries, 1 wall charger and 1 USB charger, cartridges/refills in menthol or regular (patient choice).
The number of cartridges is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day.
We plan to decrease the strength of the cartridges by one half after three weeks of intervention.
We will give each women supplies and instructions accordingly.
This will allow for a lower strength of nicotine as each woman continues with smoking cessation.
|
The number of cartridges for the electronic cigarettes is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day.
We plan to decrease the strength of the cartridges by one half after three weeks of intervention.
We will give each women supplies and instructions accordingly.
This will allow for a lower strength of nicotine as each woman continues with smoking cessation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite set of questions about the feasibility of successfully using NRT and ENDS over time (assessing change in smoking habits) in Women with Serious Gynecological Conditions
Time Frame: We plan a 3-month study with 6 week follow-up periods.
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To determine the acceptability of traditional nicotine replacement therapy (nicotine patch plus nicotine gum or lozenges) and the ENDS (electronic nicotine delivery system or electronic cigarette as smoking cessation tools in a group of women with cervical dysplasia from the Stephenson Cancer Center Dysplasia Clinics. Measurements to assess success:
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We plan a 3-month study with 6 week follow-up periods.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Study
Time Frame: 3 months with 6 week follow-up windows
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To determine if we can accure 30 smoking women with cervical dysplasia from the Stephenson Cancer Center for smoking cessation intervention in a 6-month window.
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3 months with 6 week follow-up windows
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Product Adherence Diary
Time Frame: Women fill out diary every day for 12 weeks
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The diary will be used for the 6 week intervention portion of the study.
This diary is designed to assist individuals in monitoring their smoking and product use during the study.
We will encourage each subject to write down every regular cigarette that she smokes as well as every use of the product to which she has been randomized.
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Women fill out diary every day for 12 weeks
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Composite set of semi-structured interviews
Time Frame: done at the end of the study (at 12-weeks)
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We will use semi-structured interviews at the 12 week follow-up to help us understand:
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done at the end of the study (at 12-weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura A Beebe, PhD, University of Oklahoma Health Sciences Center, College of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2506
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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