SmokingNCT02600273
Novel Approaches to Reducing Tobacco Related Harm
A study testing Usual brand cigarettes, Lower nicotine content cigarettes and Electronic cigarettes 1 in people with Smoking and Tobacco Smoking Behavior, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco Smoking Behavior, Cigarette Smoking
- What is being tested?
- Usual brand cigarettes, Lower nicotine content cigarettes and Electronic cigarettes 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- HIV-infected adults age 18 and older currently receiving HIV care
- Self-report smoking ≥10 cigarettes/day of a brand delivering >0.5mg nicotine for >2yrs
- Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine >100ng/ml (as measured with NicAlert)
Who cannot join
- Impaired mental status as assessed by observation
- Acute intoxication as measured by breath alcohol level (BAL) > 0
- Current use of nicotine replacement or other pharmacotherapy for smoking cessation
- Previous use of e-cigarettes
- Use of other tobacco products (e.g., chew tobacco, cigars) on > 10 of the past 30 days
- Unstable HIV or associated comorbidities, as determined by a licensed medical professional.
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- Pregnancy (Females testing positive for pregnancy and any participants wishing to quit immediately will be referred to community smoking cessation treatment and will be excluded from the study)
- Blood pressure at or above 160/100 or below 90/50
- Heart rate at or above 105 bpm or below 45 bpm
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27707
About this study
Official title: Novel Approaches to Reducing Tobacco Related Harm Among HIV-Infected Smokers
The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV.
Read the detailed description
Participants will sample 4 alternative nicotine/tobacco products and provide initial reactions to the products.
- Conditions
- Smoking, Tobacco Smoking Behavior, Cigarette Smoking
- Being tested
- Usual brand cigarettes, Lower nicotine content cigarettes, Electronic cigarettes 1, Electronic cigarettes 2
- Medical subject headings
- Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual brand cigarettesOther
Usual brand cigarettes
Lower nicotine content cigarettesOther
SPECTRUM research cigarettes
Electronic cigarettes 1Other
Electronic cigarette with 0 g/mL e-liquid
Electronic cigarettes 2Other
Electronic cigarette with 18 g/mL e-liquid
| Study group | Role | What they receive |
|---|---|---|
| Usual brand cigarettes | Active comparator | During one session, participants will smoke their usual brand cigarettes Receives: Other: Usual brand cigarettes |
| Lower nicotine content cigarettes | Experimental | During one session, participants will smoke SPECTRUM Research Cigarettes Receives: Other: Lower nicotine content cigarettes |
| Electronic cigarettes 1 | Experimental | During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid Receives: Other: Electronic cigarettes 1 |
| Electronic cigarettes 2 | Experimental | During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid Receives: Other: Electronic cigarettes 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective effects, as measured by survey
Satisfaction, acceptability, withdrawal, craving
Measured: within 2 minutes after sampling product(s)
Risk perceptions, as measured by survey
Risk perceptions of products
Measured: Before and within 2 minutes after sampling product(s)
Interest and confidence in quitting, as measured by survey
Interest and confidence in using and purchasing the tested products in the future
Measured: within 2 minutes after sampling product(s)
Secondary outcomes (1)
Reinforcing properties of product(s), as measured by survey
Behavioral economics measures (commodity purchase task \& cross-price elasticity)
Measured: within 2 minutes after sampling product(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startJan 2017
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- F. Joseph McClernon, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600273
- Sponsor's protocol ID
- Pro00067757
- Other IDs
- 5P30AI064518
- Status last verified
- Sep 2020
- First submitted
- 5 Nov 2015
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches to Reducing Tobacco Related Harm Among HIV-Infected Smokers
- ClinicalTrials.gov ID
- NCT02600273
- Acronym / sponsor ID
- Pro00067757
- Conditions
- Smoking, Tobacco Smoking Behavior, Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 9 Nov 2015 (estimated)
- 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.
The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV.
Detailed description
Participants will sample 4 alternative nicotine/tobacco products and provide initial reactions to the products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual brand cigarettes | Active comparator | Other: Usual brand cigarettesDuring one session, participants will smoke their usual brand cigarettes |
| Lower nicotine content cigarettes | Experimental | Other: Lower nicotine content cigarettesDuring one session, participants will smoke SPECTRUM Research Cigarettes |
| Electronic cigarettes 1 | Experimental | Other: Electronic cigarettes 1During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid |
| Electronic cigarettes 2 | Experimental | Other: Electronic cigarettes 2During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected adults age 18 and older currently receiving HIV care
- Self-report smoking ≥10 cigarettes/day of a brand delivering >0.5mg nicotine for >2yrs
- Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine >100ng/ml (as measured with NicAlert)
Key exclusion criteria (9 listed)
- Impaired mental status as assessed by observation
- Acute intoxication as measured by breath alcohol level (BAL) > 0
- Current use of nicotine replacement or other pharmacotherapy for smoking cessation
- Previous use of e-cigarettes
- Use of other tobacco products (e.g., chew tobacco, cigars) on > 10 of the past 30 days
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 |
|---|---|---|
| Usual brand cigarettesUsual brand cigarettes | Other | Usual brand cigarettes |
| Lower nicotine content cigarettesSPECTRUM research cigarettes | Other | Lower nicotine content cigarettes |
| Electronic cigarettes 1Electronic cigarette with 0 g/mL e-liquid | Other | Electronic cigarettes 1 |
| Electronic cigarettes 2Electronic cigarette with 18 g/mL e-liquid | Other | Electronic cigarettes 2 |
Primary outcome
Subjective effects, as measured by survey
Time frame: within 2 minutes after sampling product(s)
Satisfaction, acceptability, withdrawal, craving
Risk perceptions, as measured by survey
Time frame: Before and within 2 minutes after sampling product(s)
Risk perceptions of products
Interest and confidence in quitting, as measured by survey
Time frame: within 2 minutes after sampling product(s)
Interest and confidence in using and purchasing the tested products in the future
1 secondary outcome
Reinforcing properties of product(s), as measured by survey
Time frame: within 2 minutes after sampling product(s)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
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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. This study is not recruiting at the moment.
F. Joseph McClernon, PhD principal investigator
Duke 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 Usual brand cigarettes, Lower nicotine content cigarettes and Electronic cigarettes 1 in people with Smoking and Tobacco Smoking Behavior, run by Duke 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 3 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: finished, as of the sponsor's last update on 30 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective effects, as measured by survey (time frame: within 2 minutes after sampling product(s)). The study lists 3 primary outcomes in all. 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 30 Sep 2020.