Cigarette Smoking, Smoking, Tobacco Smoking Behavior
Conditions
Brief summary
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.
Interventions
OTHERUsual brand cigarettes
Usual brand cigarettes
OTHERLower nicotine content cigarettes
SPECTRUM research cigarettes
OTHERElectronic cigarettes 1
Electronic cigarette with 0 g/mL e-liquid
OTHERElectronic cigarettes 2
Electronic cigarette with 18 g/mL e-liquid
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV-infected adults age 18 and older currently receiving HIV care 2. Self-report smoking ≥10 cigarettes/day of a brand delivering \>0.5mg nicotine for \>2yrs 3. Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine \>100ng/ml (as measured with NicAlert)
Exclusion criteria
1. Impaired mental status as assessed by observation 2. Acute intoxication as measured by breath alcohol level (BAL) \> 0 3. Current use of nicotine replacement or other pharmacotherapy for smoking cessation 4. Previous use of e-cigarettes 5. Use of other tobacco products (e.g., chew tobacco, cigars) on \> 10 of the past 30 days 6. Unstable HIV or associated comorbidities, as determined by a licensed medical professional. 7. 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) 8. Blood pressure at or above 160/100 or below 90/50 9. Heart rate at or above 105 bpm or below 45 bpm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective effects, as measured by survey | within 2 minutes after sampling product(s) | Satisfaction, acceptability, withdrawal, craving |
| Risk perceptions, as measured by survey | Before and within 2 minutes after sampling product(s) | Risk perceptions of products |
| Interest and confidence in quitting, as measured by survey | within 2 minutes after sampling product(s) | Interest and confidence in using and purchasing the tested products in the future |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reinforcing properties of product(s), as measured by survey | within 2 minutes after sampling product(s) | Behavioral economics measures (commodity purchase task & cross-price elasticity) |
Countries
United States
Outcome results
None listed