Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial studies how well different levels of nicotine in very low nicotine content cigarettes and electronic cigarettes (e-cigarettes) work in promoting smoking cessation in current daily and intermittent smokers. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior, including finding it easier to quit smoking, in current daily and intermittent smokers.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Sign consent and agree to all study procedures

• Have a telephone and address where they may be reached

• Able to follow verbal and written instructions in English

• Be the only participant in their household

• Interested in trying novel nicotine products

• Daily smokers: >= 1 cigarette/little cigar per day

• Intermittent smokers: >= 1 cigarette/little cigar per day 4 to 27 days per month

Exclusion Criteria:

• Unwilling to refrain from other e-cigarette use for the duration of the study, other than what is provided to them for study purposes

• Positive urine screen for illicit drugs except marijuana

• Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded

• Participants failing the urine drug screen (except marijuana which is not exclusionary) will be allowed to re-screen once. If they test positive again, they will not be allowed to return)

• Current/recent use of certain medications:

• Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, Zyban, nicotine replacement therapy [NRT], Chantix)

• Certain medications to treat depression (last 14 days; e.g., amitriptyline)

• A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin)

• Daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (e.g., 3 to 7 days per week or less or if more frequent, use less than a month's duration

• Unstable medical condition as determined by the medical team

• Bronchial or respiratory infection in the last 14 days

• Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading is < 50 (severe to very severe obstruction)

• Subject experienced abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months

• Subject's screening blood pressure reading >= 180/110

• Meet criteria for major depressive syndrome or suicidality on the Patient Health Questionnaire-9 (PHQ-9)

• Self report of past or current diagnosis of bi-polar disorder or schizophrenia/schizoaffective disorder

• Other tobacco use besides cigarettes or little cigars (e.g., hookah, cigarillos, smokeless tobacco, chewing tobacco, pipes, cigars, etc.) on 10 or more days in the last month

• Recent (past 90 days), current, or planned (within the next 45 days) involvement in smoking cessation activities

• Positive urine pregnancy test at screening. Women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test

• Women that are breastfeeding or of childbearing potential and not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include:

• Approved hormonal contraceptives (such as birth control pills, patches, implants or injections)

• Barrier methods (such as condom or diaphragm) used with a spermicide, or

• An intrauterine device (IUD)

• Contraceptives sold for emergency use after unprotected sex are not acceptable methods for routine use

• Subject considered by the investigator to be unsuitable to participate in the study (e.g., due to cognitive deficits or instability to last the entire duration of the study)