Novel Approaches to Reducing Tobacco Related Harm

Duke University

Status: Completed

Conditions: Cigarette Smoking; Tobacco Smoking Behavior; Smoking

Treatments: Other: Electronic cigarettes 2; Other: Electronic cigarettes 1; Other: Usual brand cigarettes; Other: Lower nicotine content cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02600273

Pro00067757

5P30AI064518 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 4 patient groups

Usual brand cigarettes

Active Comparator group

Description:

During one session, participants will smoke their usual brand cigarettes

Treatment:

Other: Usual brand cigarettes

Lower nicotine content cigarettes

Experimental group

Description:

During one session, participants will smoke SPECTRUM Research Cigarettes

Treatment:

Other: Lower nicotine content cigarettes

Electronic cigarettes 1

Experimental group

Description:

During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid

Treatment:

Other: Electronic cigarettes 1

Electronic cigarettes 2

Experimental group

Description:

During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid

Treatment:

Other: Electronic cigarettes 2