Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT) (CONNECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03453385|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Smoking Tobacco Use||Behavioral: Electronic Cigarette||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)|
|Actual Study Start Date :||May 24, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
No Intervention: Control
Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like.
Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like.
Behavioral: Electronic Cigarette
An e-cigarette and four weeks of e-liquid provided to participants.
- Uptake [ Time Frame: Study Enrollment through end of 4-week intervention ]mean days of use over 4-week sampling period
- Conversion [ Time Frame: Study enrollment through end of 6-month follow up ]Percentage of participants who purchase an e-cigarette
- Smoking Cessation [ Time Frame: 6-month follow-up ]Point prevalence abstinence from conventional smoking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453385
|Contact: Amy Boatrightemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Amy Boatright 800-375-0516|