Very Low Nicotine Cigarettes + E-Cigarettes for Smoking Cessation

Overseen By Paul Cinciripini, PHD, MS, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Smoking cessation, Antidepressants, Opioids, others

Disqualifiers: Unstable condition, Cardiovascular disease, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

212 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies what would happen if the nicotine levels in cigarettes are greatly reduced, but electronic cigarettes containing different amount of nicotine are available. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior in current daily and intermittent smokers..

Research Team

Paul Cinciripini

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for daily and intermittent cigarette smokers who are interested in trying novel nicotine products. Participants must be able to follow instructions in English, have only one person per household join, and can receive mail and do telehealth visits. They cannot use other e-cigarettes or smoking cessation meds recently, have severe respiratory issues, unstable medical conditions, certain mental health diagnoses, or be pregnant/breastfeeding without birth control.

Inclusion Criteria

Have an address where he/she can receive mail

Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access, etc.)

Able to follow verbal and written instructions in English

Exclusion Criteria

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

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

I have recently quit smoking, am trying to quit, or plan to quit within 45 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I

Participants smoke their usual cigarettes brand

1 week

Phase II

Participants smoke VLNCC cigarettes provided

3 weeks

Phase III-IV

Participants are randomized to smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks, or vice versa

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Electronic Cigarette
• Nicotine Replacement
• Very Low Nicotine Content Cigarette

Trial Overview The study tests the effects of greatly reduced nicotine levels in cigarettes versus electronic cigarettes with varying nicotine content on smoker behavior. It aims to see how these changes affect withdrawal symptoms, cravings for nicotine, mood swings, and overall smoking habits among current smokers.

Participant Groups

Group I: Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo) Experimental Treatment 7 Interventions

PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.

Group II: Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo) Experimental Treatment 7 Interventions

PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+