Novel Approaches to Reducing Tobacco Related Harm

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600273
• Other study ID #: Pro00067757
• Secondary ID: 5P30AI064518
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: September 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Smoking
• Tobacco Smoking Behavior

Intervention

Other:
• Usual brand cigarettes
Usual brand cigarettes
• Lower nicotine content cigarettes
SPECTRUM research cigarettes
• Electronic cigarettes 1
Electronic cigarette with 0 g/mL e-liquid
• Electronic cigarettes 2
Electronic cigarette with 18 g/mL e-liquid

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective effects, as measured by survey	Satisfaction, acceptability, withdrawal, craving	within 2 minutes after sampling product(s)
Primary	Risk perceptions, as measured by survey	Risk perceptions of products	Before and within 2 minutes after sampling product(s)
Primary	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	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)