Smoking Cessation in Women With Gynecological Conditions

NCT01989923 | Completed

• 1 other identifier: 2506
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will compare two smoking cessation methods, traditional nicotine replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in patients with gynecological conditions.

Conditions

Cervical Dysplasia

Keywords

Smoking cessation; Traditional nicotine replacement therapy; Electronic nicotine delivery devices; electronic cigarettes; cervical dysplasia

Outcome Measures

Primary Outcomes (1)

• 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

  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: 1. Reduction of number of cigarettes smoked per day. 2. Point prevalence abstinence at 7 and 30 days 3. Smoking cessation rates 4. Qualitative interviews to assess positives and negatives in these two smoking cessation methods.

  We plan a 3-month study with 6 week follow-up periods.

Secondary Outcomes (1)

• Feasibility of Study

  3 months with 6 week follow-up windows

Other Outcomes (2)

• Product Adherence Diary

  Women fill out diary every day for 12 weeks

• Composite set of semi-structured interviews

  done at the end of the study (at 12-weeks)

Study Arms (2)

Nicotine replacement therapy

ACTIVE COMPARATOR

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.

Other: Nicotine Replacement Therapy

Electronic Cigarettes

ACTIVE COMPARATOR

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.

Device: Electronic Cigarettes

Interventions

Nicotine Replacement Therapy OTHER

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.

Also known as: Nicoderm CQ patches (21 or 14 mg patches), Nicorette gum (2 mg), Nicorette lozenges (2 mg)

Nicotine replacement therapy

Electronic Cigarettes DEVICE

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

Also known as: Blu Cig Electronic Nicotine Delivery System

Electronic Cigarettes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Smoking Cessation; Vaping

Interventions

Nicotine Replacement Therapy; Transdermal Patch

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Equipment and Supplies

Study Officials

• Laura A Beebe, PhD

  University of Oklahoma Health Sciences Center, College of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: November 21, 2013
• Study Start: June 1, 2013
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

US (1)