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OpenTrials
Completed

NCT Number: NCT02600273

Novel Approaches to Reducing Tobacco Related Harm

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

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Key information

Conditions

Smoking Behavior Cigarette Smoking Tobacco Smoking Tobacco Smoking Behavior Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University School of Medicine

Durham, North Carolina, 27707, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual brand cigarettes

Other

Usual brand cigarettes

Lower nicotine content cigarettes

Other

SPECTRUM research cigarettes

Electronic cigarettes 1

Other

Electronic cigarette with 0 g/mL e-liquid

Electronic cigarettes 2

Other

Electronic cigarette with 18 g/mL e-liquid

Primary outcomes

  1. Subjective effects, as measured by survey

    Time frame: within 2 minutes after sampling product(s)

    Satisfaction, acceptability, withdrawal, craving

  2. Risk perceptions, as measured by survey

    Time frame: Before and within 2 minutes after sampling product(s)

    Risk perceptions of products

  3. 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

Secondary outcomes

  1. Reinforcing properties of product(s), as measured by survey

    Time frame: within 2 minutes after sampling product(s)

    Behavioral economics measures (commodity purchase task & cross-price elasticity)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2015
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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