NCT03589599

Brief Summary

This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure. Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant exposure among waterpipe users. Findings from this study will help informing flavor-based product regulation by the FDA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 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

Study Start

First participant enrolled

March 21, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

June 11, 2018

Last Update Submit

July 30, 2020

Conditions

Waterpipe Smoking

Outcome Measures

Primary Outcomes (1)

  • Plasma nicotine

    Change in plasma nicotine level

    During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period

Secondary Outcomes (7)

  • Puff topography

    During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)

  • Minnesota Nicotine Withdrawal Scale

    During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.

  • Tiffany-Drobes Questionnaire of Smoking Urges

    During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.

  • Carbon monoxide levels

    During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period

  • Harm perception

    During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.

  • +2 more secondary outcomes

Other Outcomes (2)

  • Heart rate

    During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr

  • Blood pressure

    During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session

Study Arms (2)

Flavored tobacco

EXPERIMENTAL

All participants will be completing a lab visit where they smoke flavored waterpipe tobacco ad lib for up to 45 min.

Other: Flavored tobacco

Non-flavored tobacco

EXPERIMENTAL

All participants will be completing a lab visit where they smoke non-flavored waterpipe tobacco ad lib for up to 45 min.

Other: Non-flavored tobacco

Interventions

Flavored tobaccoOTHER

Effects of flavored tobacco

Flavored tobacco
Non-flavored tobaccoOTHER

Effects of non-flavored tobacco

Non-flavored tobacco

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy individuals (determined by physical examination).
  • Age of 18-30 years.
  • Is willing to provide informed consent.
  • Is willing to attend the lab as required by the study protocol.
  • WP smokers who smoke flavored WP tobacco.
  • Have abstained from WP for 12 hours prior to each session

You may not qualify if:

  • Report smoking cigarettes regularly (\> 5 cigarettes/month in the past year).
  • Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
  • Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
  • Individuals with self-reported history of chronic disease or psychiatric conditions.
  • Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Water Pipe Smoking

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Department of Epidemiology

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 18, 2018

Study Start

March 21, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

US(1)