- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862924
Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV (ProjectSREC)
Health Effects of the Standardized Research E-Cigarette for Harm Reduction in Smokers With HIV
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aims The specific aims are to examine: 1) the feasibility and acceptability of EC distribution in PLWH; 2) the effect of EC use on smoking behaviors; and 3) the change in cardiopulmonary symptoms and biomarkers in smokers who transition from CC to EC use.
Methodology The investigators will enroll 72 HIV-positive smokers, who are not ready or willing to quit smoking, into a 12-week randomized study. Participants will be assigned to one of two groups: 1) to receive 6-weeks of free electronic cigarettes (a standardized form developed by the NIH) and encouraged to use them whenever they would smoke a regular cigarette, or, 2) to continue to smoke their usual brand. At weekly visits for 6 weeks, the investigators will measure EC and (regular) combustible cigarette (CC) use, heart and lung symptoms (such as blood pressure, heart rate, shortness of breath, cough). At baseline (start of study) and the week 6 visit, the investigators will obtain blood and urine samples to look at measures of inflammation and coagulation that are related to heart and lung disease. The investigators will also measure tobacco toxicant exposure levels.
At week 6, all participants will receive advice to stop smoking and a referral to the RI Department of Health Quitline (a state-funded smoking cessation resource/program), if desired.
At week 12, any change in smoking habits, and any attempts to quit smoking will be examined.
Participation Population The investigators will recruit participants (N=72 enrolled) from the Miriam Immunology Center (MIC) and the Providence community using study flyers and active recruitment via a recruitment research assistant (RA) at the Miriam Immunology Center. The Miriam-based RA will review in advance the medical records for the upcoming day's appointment to identify potential participants (HIV-positive smokers). Potential participants will be screened in person at the MIC or screened by phone if they instead choose to call the study phone number for screening. Participants in the clinic and those who respond to advertisements via phone will first be screened using the brief telephone interview form. The phone screen will allow the investigators to determine preliminary eligibility for this study. Upon initial eligibility, individuals will be invited to a baseline assessment interview at the Center for Alcohol & Addiction Studies research lab at 121 South Main Street to further determine study eligibility. The investigators estimate that approximately 140 participants will be screened and consented to enroll a sample of 72 into this study. The telephone screen forms will be destroyed once eligibility is determined.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: PATRICIA A CIOE, PhD
- Phone Number: 401-863-6638
- Email: patricia_cioe@brown.edu
Study Contact Backup
- Name: Jasmine DiLorenzo, BA
- Phone Number: 401-863-6645
- Email: jasminette_dilorenzo@brown.edu
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02912
- Recruiting
- Brown University School of Public Health
-
Contact:
- Garrett Stang, MA
- Phone Number: 401-863-6011
- Email: garrett_stang@brown.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosed with and engaged in care for HIV (defined as at least one HIV clinic medical appointment within the past six month period)
- at least 18 years of age
- smoke at least 5 cigarettes per day for longer than one year
- exhaled carbon monoxide (CO) level greater than 5 at BL
Exclusion Criteria:
- intention to quit smoking in the next 30 days
- currently using pharmacotherapy for smoking cessation
- currently using electronic cigarettes more than 2 days/week
- unstable medical or psychiatric condition (defined as hospitalization)
- medical contraindications to nicotine (unstable angina, uncontrolled hypertension, or recent cardiovascular event, including hospitalization)
- psychotic symptoms
- substance use disorder other than nicotine dependence
- past-month suicidal ideation or past-year suicide attempt
- pregnant or nursing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active condition
Participants in the active condition will be provided with the Standardized Research Electronic Cigarette (SREC) and will be encouraged to use the SREC whenever they would normally smoke a cigarette.
|
Participants will receive SREC weekly and eill be encouraged to replace their usual combustible cigarette with the SREC whenever they would normally smoke.
Other Names:
|
No Intervention: Standard Condition
Participants in this condition will be asked to continue to smoke their usual brand of cigarettes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in combustible cigarette use from baseline to 6 weeks
Time Frame: 6 weeks
|
Daily use of combustible cigarettes will be measured using the Timeline Followback method
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Expired carbon monoxide (CO) level from baseline to 6 weeks
Time Frame: 6 weeks
|
A carbon monoxide (CO) level of less than five (<5) will indicate a complete switch to the electronic cigarette
|
6 weeks
|
Change in serum biomarker levels from baseline to 6 weeks
Time Frame: 6 weeks
|
Soluble CD14, is a biomarker of monocyte activation; Soluble CD163, is a biomarker of monocyte/macrophage activation (sCD163); high sensitivity C-reactive protein (hs-CRP), is an acute phase reactant; D-dimer, is a marker of coagulation; IL-6, is a biomarker of inflammation.
|
6 weeks
|
Change in tobacco toxicant levels from baseline to 6 weeks
Time Frame: 6 weeks
|
Total Nicotine equivalents is a measure of the by products of nicotine metabolism, including cotinine.
NNAL is a tobacco specific nitrosamine.
|
6 weeks
|
Change in Forced expiratory volume in 1 sec (FEV1) from baseline to 6 weeks
Time Frame: 6 weeks
|
FEV1 is a measure of pulmonary function
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: PATRICIA A CIOE, PhD, Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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