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Trial record 1 of 1 for:    Novel Approaches to Reducing Tobacco Related Harm
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Novel Approaches to Reducing Tobacco Related Harm

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ClinicalTrials.gov Identifier: NCT02600273
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Smoking Tobacco Smoking Behavior Cigarette Smoking Other: Usual brand cigarettes Other: Lower nicotine content cigarettes Other: Electronic cigarettes 1 Other: Electronic cigarettes 2 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Novel Approaches to Reducing Tobacco Related Harm Among HIV-Infected Smokers
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600273


Locations
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United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27707
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: F. Joseph McClernon, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02600273    
Other Study ID Numbers: Pro00067757
5P30AI064518 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: November 2019
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action