NCT02600273

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

November 5, 2015

Last Update Submit

September 28, 2020

Conditions

SmokingTobacco Smoking BehaviorCigarette Smoking

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

    within 2 minutes after sampling product(s)

Study Arms (4)

Usual brand cigarettes

ACTIVE COMPARATOR

During one session, participants will smoke their usual brand cigarettes

Other: Usual brand cigarettes

Lower nicotine content cigarettes

EXPERIMENTAL

During one session, participants will smoke SPECTRUM Research Cigarettes

Other: Lower nicotine content cigarettes

Electronic cigarettes 1

EXPERIMENTAL

During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid

Other: Electronic cigarettes 1

Electronic cigarettes 2

EXPERIMENTAL

During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid

Other: Electronic cigarettes 2

Interventions

Usual brand cigarettesOTHER

Usual brand cigarettes

Usual brand cigarettes
Lower nicotine content cigarettesOTHER

SPECTRUM research cigarettes

Lower nicotine content cigarettes
Electronic cigarettes 1OTHER

Electronic cigarette with 0 g/mL e-liquid

Electronic cigarettes 1
Electronic cigarettes 2OTHER

Electronic cigarette with 18 g/mL e-liquid

Electronic cigarettes 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

SmokingCigarette Smoking

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingTobacco Use

Study Officials

  • F. Joseph McClernon, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 9, 2015

Study Start

January 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

US(1)