The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products

NCT03492463 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro00084132P50DA027840-07
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.

Conditions

Nicotine Dependence, Cigarettes

Keywords

Nicotine addiction; Cigarette smoking; Nicotine patches; E-cigarettes

Outcome Measures

Primary Outcomes (1)

• Expired Air Carbon Monoxide (CO) to Assess Recent Smoking

  The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).

  Week 8

Secondary Outcomes (3)

• Cigarette Use, Assessed by Self-report in Daily Dairies

  Week 8

• E-cigarette Use, Assessed by Self-report in Daily Dairies

  Week 8

• Total Urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

  Week 8

Study Arms (4)

Nicotine e-cigs + Nicotine patches

ACTIVE COMPARATOR

Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.

Drug: Nicotine patch; Other: E-cigarettes

Non-nicotine e-cigs + Nicotine patches

ACTIVE COMPARATOR

Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.

Drug: Nicotine patch; Other: Non-nicotine e-cigarettes

Nicotine e-cigs + Placebo patches

ACTIVE COMPARATOR

Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.

Other: Placebo patch; Other: E-cigarettes

Non-nicotine e-cigs + Placebo patches

PLACEBO COMPARATOR

Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.

Other: Placebo patch; Other: Non-nicotine e-cigarettes

Interventions

Nicotine patch DRUG

Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.

Also known as: NicoDerm

Nicotine e-cigs + Nicotine patches; Non-nicotine e-cigs + Nicotine patches

Placebo patch OTHER

Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.

Nicotine e-cigs + Placebo patches; Non-nicotine e-cigs + Placebo patches

E-cigarettes OTHER

Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.

Also known as: Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettes

Nicotine e-cigs + Nicotine patches; Nicotine e-cigs + Placebo patches

Non-nicotine e-cigarettes OTHER

Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.

Also known as: Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettes

Non-nicotine e-cigs + Nicotine patches; Non-nicotine e-cigs + Placebo patches

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoke an average of at least 10 cigarettes per day;
• Have smoked at least one cumulative year;
• Have an expired air CO reading of at least 10ppm;
• Have a body weight of \> 110 lbs. (50 kg) and ≤ 300 lbs. (136 kg);
• Are able to read and understand English;
• Potential subjects of child bearing potential must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study:
• Participation in any other nicotine-related modification strategy outside of this protocol;
• Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco;
• Use of e-cigarettes other than the ones provided during the study;
• Use of experimental (investigational) drugs or devices;
• Use of illegal drugs;

You may not qualify if:

• Seeking treatment for nicotine dependence.
• Hypertension - systolic BP \> 160 mm Hg, diastolic BP \> 100 mm Hg. Individuals with a history of hypertension may be allowed to participate in the study if the study physician or medical provider determines that the condition is stable and will not jeopardize the individual's safety.
• Hypotension (with symptoms) - systolic BP \< 90 mm Hg, diastolic BP \< 60 mm Hg.
• Coronary heart disease with symptoms (e.g., chest pain)
• Heart attack in the past year
• Cardiac rhythm disorder (irregular heart rhythm with symptoms)
• Chest pain in the last month (unless history indicates a non-cardiac source)
• Symptomatic heart disorder such as heart failure
• Advanced liver or kidney disease that requires medication or dialysis, paracentesis
• Major gastrointestinal illness (e.g. Celiac disease, Crohn's dx Ulcerative Colitis)
• Bleeding stomach ulcers in the past 30 days
• Lung disease that requires oxygen
• Major brain disorder (including stroke with residual deficit, brain tumor, and seizure disorder)
• Migraine headaches that occur more frequently than once per week
• Recent, unexplained fainting spells

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Vaping

Interventions

Tobacco Use Cessation Devices; Nicotine; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jed E. Rose, Ph.D.
• Organization: Duke University

jed.rose@duke.edu

919-668-5055

Study Officials

• Jed E. Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: August 6, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 8, 2023
• Results First Posted: June 28, 2022

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)