Novel Approaches to Reducing Tobacco Related Harm

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

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

Study Overview

• Status: Completed
• Conditions: Smoking; Cigarette Smoking; Tobacco Smoking Behavior
• Intervention / Treatment: Other: Usual brand cigarettes; Other: Lower nicotine content cigarettes; Other: Electronic cigarettes 1; Other: Electronic cigarettes 2

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: F. Joseph McClernon, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro00067757; 5P30AI064518 (U.S. NIH Grant/Contract)