NCT02228824

Brief Summary

The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

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

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

August 27, 2014

Results QC Date

July 29, 2018

Last Update Submit

October 5, 2018

Conditions

Smoking

Keywords

SmokingNon-daily smokersEcological Momentary AssessmentBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in Cigarette Consumption

    Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data

    Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period

Secondary Outcomes (4)

  • Exposure Measure - Solanesol

    Post-randomization time points at study weeks 4, 8, 12

  • Exposure Measure - Smoking Topography

    Post-randomization study visits at study weeks 4, 8, 12

  • Exposure Measure - Cotinine (Logged)

    Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)

  • Exposure Measure - Cigarette Butt Weight

    Entire length of study, through completion, up to 12 weeks

Study Arms (2)

Very low nicotine content cigarettes

EXPERIMENTAL
Drug: Very low nicotine content cigarettes

Normal nicotine content cigarettes

ACTIVE COMPARATOR
Drug: Normal nicotine content cigarettes

Interventions

Very low nicotine content cigarettesDRUG

0.07 mg nicotine delivery

Very low nicotine content cigarettes
Normal nicotine content cigarettesDRUG

0.8 mg nicotine delivery

Normal nicotine content cigarettes

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older, and smoking cigarettes for at least 3 years
  • smoking, on average, 4-27 days per month
  • smoking at current rate for at least the previous 3 months
  • willingness to try novel cigarettes

You may not qualify if:

  • active plans to quit or actively seeking smoking cessation treatment in the next 3 months
  • severe psychiatric disorders that may interfere with study procedures
  • current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
  • exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
  • \[for female participants\] being pregnant or breastfeeding, or planning to become pregnant, by self-report
  • current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
  • occurrence of heart attack, stroke, or angina in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smoking Research Group, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Shiffman S, Kurland BF, Scholl SM, Mao JM. Nondaily Smokers' Changes in Cigarette Consumption With Very Low-Nicotine-Content Cigarettes: A Randomized Double-blind Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):995-1002. doi: 10.1001/jamapsychiatry.2018.1831.

    PMID: 29902305DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Saul Shiffman
Organization
University of Pittsburgh
shiffman@pinneyassociates.com
412-567-1761

Study Officials

  • Saul Shiffman, PhD

    University of Pittsburgh, Department of Psychology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

June 1, 2015

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

October 31, 2018

Results First Posted

October 31, 2018

Record last verified: 2018-10

Locations

US(1)