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Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

NCT02487953 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-09-12

No results posted yet for this study

Summary

The purpose of this research study is to determine whether combining electronic nicotine delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared to either treatment alone.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Nicotine patch

21 mg/24 h for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.

OTHER

ENDS

As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.

OTHER

Placebo patch

21 mg size for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg size for 2 weeks, and 7 mg size for 2 weeks.

OTHER

Placebo ENDS

As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Jed E Rose, Ph.D. · Duke University

  • James M Davis, M.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2020-01-31
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487953 on ClinicalTrials.gov