Trials Sponsors Conditions Drugs Pricing

Conditions

Bladder Cancer Cancer of Head and Neck Lung Cancer Nicotine Dependence, Other Tobacco Product

Outcome Measures

Primary Outcomes (2)

Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day
Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.
12 Weeks
Average Number of E-cigarettes Used Per Day
Average number of e-cigarettes used per day over the 12 week period
12 Weeks

Study Arms (2)

HALO G6

ACTIVE COMPARATOR

HALO cigalike model

Device: HALO

HALO Triton

ACTIVE COMPARATOR

HALO tank model

Device: HALO

Interventions

HALODevice

HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.

HALO G6HALO Triton

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histological or cytological diagnosis of lung, head \& neck, or bladder cancer within the past 5 years.
AJCC (American Joint Committee on Cancer) stages I-IV

Sponsors & Collaborators

Dartmouth-Hitchcock Medical Center
Otherlead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

MeSH Terms

Conditions

Tobacco Use DisorderUrinary Bladder NeoplasmsLung NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder Diseases

Results Point of Contact

Title: Dr James Sargent
Organization: The Koop Institute at Dartmouth, Geisel School of Medicine

Study Officials

James D Sargent, MD
Dartmouth College
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

19 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Pediatric Oncology

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 6, 2016

Study Start

June 2016

Actual (reported)

Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

HALO G6

HALO Triton

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

HALO G6

HALO Triton

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations