HIVProjectSRECNCT03862924
Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV
A study testing Standardized Research Electronic Cigarette in people with HIV, run by Brown University at 1 site in United States.
Trial summary
Cigarette smoking is more prevalent (50-70%) in persons living with HIV in the U.S. when compared with the general population and is linked to increased rates of heart disease, lung diseases and infections, and lung cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Standardized Research Electronic Cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- substance use disorder other than nicotine dependence
- past-month suicidal ideation or past-year suicide attempt
- pregnant or nursing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University School of Public Health
Providence, Rhode Island, 02912
Garrett Stang, MA, 401-863-6011, garrett_stang@brown.edu
About this study
Official title: Health Effects of the Standardized Research E-Cigarette for Harm Reduction in Smokers With HIV
Cigarette smoking is more prevalent (50-70%) in persons living with HIV in the U.S. when compared with the general population and is linked to increased rates of heart disease, lung diseases and infections, and lung cancers. Because of their high levels of nicotine dependence, low quit rates, and familiarity with harm reduction, HIV-positive smokers may view the use of alternative nicotine delivery products, such as electronic cigarettes (ECs), as an attractive option for reducing and eventually stopping combustible cigarette use. However, little is known about the health effects of electronic cigarette use in HIV-positive smokers. Some studies have shown that electronic cigarette use was associated with increased confidence to quit smoking in the general population. The primary objectives of this project are to examine whether HIV-positive smokers, who are unwilling or unable to quit smoking, will substitute an electronic cigarette for regular cigarettes, and to examine whether there are any changes in heart and lung health in HIV-positive smokers who switch from regular cigarettes to electronic cigarettes.
Read the 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.
- Conditions
- HIV
- Being tested
- Standardized Research Electronic Cigarette
- Keywords
- HIV, smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Research Electronic CigaretteDevice
Also called SREC
Participants will receive SREC weekly and eill be encouraged to replace their usual combustible cigarette with the SREC whenever they would normally smoke.
| Study group | Role | What they receive |
|---|---|---|
| Active condition | Experimental | 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. Receives: Device: Standardized Research Electronic Cigarette |
| Standard Condition | No intervention | Participants in this condition will be asked to continue to smoke their usual brand of cigarettes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in combustible cigarette use from baseline to 6 weeks
Daily use of combustible cigarettes will be measured using the Timeline Followback method
Measured: 6 weeks
Secondary outcomes (4)
Change in Expired carbon monoxide (CO) level from baseline to 6 weeks
A carbon monoxide (CO) level of less than five (<5) will indicate a complete switch to the electronic cigarette
Measured: 6 weeks
Change in serum biomarker levels from baseline to 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.
Measured: 6 weeks
Change in tobacco toxicant levels from baseline to 6 weeks
Total Nicotine equivalents is a measure of the by products of nicotine metabolism, including cotinine. NNAL is a tobacco specific nitrosamine.
Measured: 6 weeks
Change in Forced expiratory volume in 1 sec (FEV1) from baseline to 6 weeks
FEV1 is a measure of pulmonary function
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Mar 2022
- Primary completion30 Apr 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once the baseline interview is complete, the study coordinator, who is not involved in conducting assessments, will randomize eligible participants to either of two study conditions. A computerized urn randomization will be used to ensure the groups are balanced on gender and Fagerström Test of Cigarette Dependence (FTCD) score, (0-5 low; 6-10 high). Participants will be randomized to an active condition (in which they will be provided with the ECs) or the standard condition (in which they will continue to smoke their usual brand). All participants will receive a daily diary and will be asked to record daily how many CCs they smoke, how many EC cartridges they use, or any use of other tobacco products (i.e. cigars, cigarillos).
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia A Cioe, Brown University
- Investigators
- PATRICIA A CIOE, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862924
- Sponsor's protocol ID
- 1U01DA045514
- Acronym
- ProjectSREC
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of the Standardized Research E-Cigarette for Harm Reduction in Smokers With HIV
- ClinicalTrials.gov ID
- NCT03862924
- Acronym / sponsor ID
- ProjectSREC / 1U01DA045514
- Conditions
- HIV
- Keywords
- HIV, smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cigarette smoking is more prevalent (50-70%) in persons living with HIV in the U.S. when compared with the general population and is linked to increased rates of heart disease, lung diseases and infections, and lung cancers. Because of their high levels of nicotine dependence, low quit rates, and familiarity with harm reduction, HIV-positive smokers may view the use of alternative nicotine delivery products, such as electronic cigarettes (ECs), as an attractive option for reducing and eventually stopping combustible cigarette use. However, little is known about the health effects of electronic cigarette use in HIV-positive smokers. Some studies have shown that electronic cigarette use was associated with increased confidence to quit smoking in the general population. The primary objectives of this project are to examine whether HIV-positive smokers, who are unwilling or unable to quit smoking, will substitute an electronic cigarette for regular cigarettes, and to examine whether there are any changes in heart and lung health in HIV-positive smokers who switch from regular cigarettes to electronic cigarettes.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once the baseline interview is complete, the study coordinator, who is not involved in conducting assessments, will randomize eligible participants to either of two study conditions. A computerized urn randomization will be used to ensure the groups are balanced on gender and Fagerström Test of Cigarette Dependence (FTCD) score, (0-5 low; 6-10 high). Participants will be randomized to an active condition (in which they will be provided with the ECs) or the standard condition (in which they will continue to smoke their usual brand). All participants will receive a daily diary and will be asked to record daily how many CCs they smoke, how many EC cartridges they use, or any use of other tobacco products (i.e. cigars, cigarillos).
| Arm | Type | Receives |
|---|---|---|
| Active condition | Experimental | Device: Standardized Research Electronic CigaretteParticipants 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. |
| Standard Condition | No intervention | –Participants in this condition will be asked to continue to smoke their usual brand of cigarettes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Research Electronic CigaretteAlso: SRECParticipants will receive SREC weekly and eill be encouraged to replace their usual combustible cigarette with the SREC whenever they would normally smoke. | Device | Active condition |
Primary outcome
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
4 secondary outcomes
Change in Expired carbon monoxide (CO) level from baseline to 6 weeks
Time frame: 6 weeks
Change in serum biomarker levels from baseline to 6 weeks
Time frame: 6 weeks
Change in tobacco toxicant levels from baseline to 6 weeks
Time frame: 6 weeks
Change in Forced expiratory volume in 1 sec (FEV1) from baseline to 6 weeks
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PATRICIA A CIOE, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Research Electronic Cigarette in people with HIV, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PATRICIA A CIOE, PhD (401-863-6638, patricia_cioe@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in combustible cigarette use from baseline to 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.