Novel Approaches to Reducing Tobacco Related Harm

Study Overview
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Brief Summary
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The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV.

Detailed Description
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Participants will sample 4 alternative nicotine/tobacco products and provide initial reactions to the products.

Official Title
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Novel Approaches to Reducing Tobacco Related Harm Among HIV-Infected Smokers

Conditions
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Smoking, Tobacco Smoking Behavior, Cigarette Smoking

Intervention / Treatment
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* Other: Usual brand cigarettes
* Other: Lower nicotine content cigarettes
* Other: Electronic cigarettes 1
* Other: Electronic cigarettes 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual brand cigarettes<br>During one session, participants will smoke their usual brand cigarettes | Other: Usual brand cigarettes<br>* Usual brand cigarettes<br>|
| Experimental: Lower nicotine content cigarettes<br>During one session, participants will smoke SPECTRUM Research Cigarettes | Other: Lower nicotine content cigarettes<br>* SPECTRUM research cigarettes<br>|
| Experimental: Electronic cigarettes 1<br>During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid | Other: Electronic cigarettes 1<br>* Electronic cigarette with 0 g/mL e-liquid<br>|
| Experimental: Electronic cigarettes 2<br>During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid | Other: Electronic cigarettes 2<br>* Electronic cigarette with 18 g/mL e-liquid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective effects, as measured by survey | Satisfaction, acceptability, withdrawal, craving | within 2 minutes after sampling product(s) | 
| Risk perceptions, as measured by survey | Risk perceptions of products | 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 | within 2 minutes after sampling product(s) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinforcing properties of product(s), as measured by survey | Behavioral economics measures (commodity purchase task & cross-price elasticity) | within 2 minutes after sampling product(s) |