NCT03856515

Brief Summary

This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
3.3 years until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 14, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 23, 2019

Results QC Date

March 25, 2025

Last Update Submit

January 9, 2026

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Cigarettes Per Day

    Mean cigarettes per day (CPD) smoked during the phase

    2 weeks

Secondary Outcomes (21)

  • Electronic Cigarette Sessions Per Day

    2 weeks

  • Total Nicotine Equivalents (TNE)

    2 weeks

  • Anabasine

    2 weeks

  • Nicotelline

    2 weeks

  • Perceived Health Risk Questionnaire (PHRQ)

    2 weeks

  • +16 more secondary outcomes

Study Arms (2)

E-Cig placebo dose followed by E-Cig nicotine dose

EXPERIMENTAL

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.

Drug: Nicotine ReplacementOther: Questionnaire AdministrationDevice: Electronic Cigarette

E-Cig nicotine dose followed by E-Cig placebo dose

EXPERIMENTAL

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.

Drug: Nicotine ReplacementOther: Questionnaire AdministrationDevice: Electronic Cigarette

Interventions

Nicotine ReplacementDRUG

Received NRT (Electronic Cigarette - With Nicotine)

Also known as: Nicotine Replacement Therapy, NRT
E-Cig nicotine dose followed by E-Cig placebo doseE-Cig placebo dose followed by E-Cig nicotine dose
Questionnaire AdministrationOTHER

Ancillary studies

E-Cig nicotine dose followed by E-Cig placebo doseE-Cig placebo dose followed by E-Cig nicotine dose
Electronic CigaretteDEVICE

Electronic Cigarette - with Nicotine

E-Cig nicotine dose followed by E-Cig placebo doseE-Cig placebo dose followed by E-Cig nicotine dose

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 21 years or older
  • Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days)
  • Have an address where he/she can receive mail
  • Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI
  • Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site.
  • Willing to use tobacco-flavored study electronic cigarettes
  • Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit.
  • The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.

You may not qualify if:

  • Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9
  • Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes).
  • Evidence of cognitive deficits or instability that would preclude reliable study participation.
  • Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
  • Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures)
  • Individuals who reside in an area that is outside of our shipping company's area of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline or are unable to come in to clinic to provide necessary samples and/or collect study products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Robinson JD, Cui Y, Karam-Hage M, Blalock JA, Shete S, Kypriotakis G, Yang P, Cinciripini PM. Standardized research electronic cigarette acceptability among adult men and women who smoke combustible cigarettes. Psychol Addict Behav. 2025 Dec;39(8):780-791. doi: 10.1037/adb0001100. Epub 2025 Oct 6.

    PMID: 41051837DERIVED

Related Links

MeSH Terms

Interventions

Nicotine Replacement Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Jason Robinson
Organization
M.D. Anderson Cancer Center
nicotinestudy@mdanderson.org
713-792-2265

Study Officials

  • Jason Robinson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

February 27, 2019

Study Start

June 2, 2022

Primary Completion

June 24, 2024

Study Completion

January 7, 2026

Last Updated

January 28, 2026

Results First Posted

July 14, 2025

Record last verified: 2026-01

Locations

US(1)