Novel Approaches to Reducing Tobacco Related Harm

Not Applicable

Completed

• Conditions: Tobacco Smoking Behavior; Smoking; Cigarette Smoking
• Interventions: Other: Usual brand cigarettes; Other: Electronic cigarettes 2; Other: Lower nicotine content cigarettes; Other: Electronic cigarettes 1

• Registration Number: NCT02600273
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-09
• Study Start: 2017-01
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual brand cigarettes	Usual brand cigarettes	During one session, participants will smoke their usual brand cigarettes
Electronic cigarettes 2	Electronic cigarettes 2	During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid
Lower nicotine content cigarettes	Lower nicotine content cigarettes	During one session, participants will smoke SPECTRUM Research Cigarettes
Electronic cigarettes 1	Electronic cigarettes 1	During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States