NCT01681875

Brief Summary

Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
839

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

9 active sites

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 30, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 30, 2012

Last Update Submit

August 13, 2018

Conditions

Tobacco Dependence

Keywords

Biomarkers of exposureCompensatory smokingNicotine dependenceReduced nicotine cigarettesTobacco withdrawal

Outcome Measures

Primary Outcomes (1)

  • Number of cigarettes smoked per day

    End of 6 week intervention

Study Arms (7)

0.8 mg nicotine with 9 mg tar

EXPERIMENTAL

very low nicotine content cigarettes SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)

Other: very low nicotine content cigarettes

0.26 mg nicotine with 9 mg tar

EXPERIMENTAL

very low nicotine content cigarettes SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar

Other: very low nicotine content cigarettes

0.12 mg nicotine with 9 mg tar

EXPERIMENTAL

very low nicotine content cigarettes SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar

Other: very low nicotine content cigarettes

0.07 mg nicotine with 9 mg tar

EXPERIMENTAL

very low nicotine content cigarettes SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar

Other: very low nicotine content cigarettes

0.03 mg nicotine with 9 mg tar

EXPERIMENTAL

very low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar

Other: very low nicotine content cigarettes

0.04 mg nicotine with 13 mg tar

EXPERIMENTAL

very low nicotine content cigarettes SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar

Other: very low nicotine content cigarettes

Usual brand

OTHER

very low nicotine content cigarettes Usual brand cigarettes (control condition)

Other: very low nicotine content cigarettes

Interventions

very low nicotine content cigarettesOTHER
0.03 mg nicotine with 9 mg tar0.04 mg nicotine with 13 mg tar0.07 mg nicotine with 9 mg tar0.12 mg nicotine with 9 mg tar0.26 mg nicotine with 9 mg tar0.8 mg nicotine with 9 mg tarUsual brand

Eligibility Criteria

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

You may qualify if:

  • Age 18+
  • Smoke an average of at least five cigarettes per day for at least 1 year
  • Breath CO levels \> 8 ppm (if ≤ 8 ppm, then NicAlert Strip \> 2)

You may not qualify if:

  • Intention to quit smoking in the next 30 days
  • Currently seeking treatment for smoking cessation
  • Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
  • A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
  • Using other tobacco products more than 9 days in the past 30 days
  • Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site)
  • Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
  • Schizophrenia and schizoaffective disorder
  • Psychiatric medication changes in the past 3 months
  • Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
  • Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
  • Participants failing the toxicology screen will be allowed to re-screen once.
  • Blood alcohol level \> 0.01
  • a. Participants failing the blood alcohol screen will be allowed to re-screen once.
  • Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male))
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33617, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of Minnesota Medical School Duluth

Duluth, Minnesota, 55812, United States

Location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55414, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (9)

  • Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug Alcohol Depend. 2009 Sep 1;104(1-2):23-33. doi: 10.1016/j.drugalcdep.2009.01.021. Epub 2009 May 15.

    PMID: 19446968BACKGROUND

  • Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.

    PMID: 20078491BACKGROUND

  • Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.

    PMID: 22354905BACKGROUND

  • Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction. 2007 Feb;102(2):324-34. doi: 10.1111/j.1360-0443.2006.01670.x.

    PMID: 17222288BACKGROUND

  • Denlinger-Apte RL, Tidey JW, Koopmeiners JS, Hatsukami DK, Smith TT, Pacek LR, McClernon FJ, Donny EC. Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes. Tob Control. 2019 May;28(3):352-355. doi: 10.1136/tobaccocontrol-2018-054622. Epub 2018 Nov 1.

    PMID: 30385649DERIVED

  • Dermody SS, McClernon FJ, Benowitz N, Luo X, Tidey JW, Smith TT, Vandrey R, Hatsukami D, Donny EC. Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence. Exp Clin Psychopharmacol. 2018 Jun;26(3):223-232. doi: 10.1037/pha0000179. Epub 2018 Mar 5.

    PMID: 29504780DERIVED

  • Rupprecht LE, Koopmeiners JS, Dermody SS, Oliver JA, al'Absi M, Benowitz NL, Denlinger-Apte R, Drobes DJ, Hatsukami D, McClernon FJ, Pacek LR, Smith TT, Sved AF, Tidey J, Vandrey R, Donny EC. Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes. Tob Control. 2017 Mar;26(e1):e43-e48. doi: 10.1136/tobaccocontrol-2016-053301. Epub 2016 Nov 17.

    PMID: 27856940DERIVED

  • Dermody SS, Tidey JW, Denlinger RL, Pacek LR, al'Absi M, Drobes DJ, Hatsukami DK, Vandrey R, Donny EC. The Impact of Smoking Very Low Nicotine Content Cigarettes on Alcohol Use. Alcohol Clin Exp Res. 2016 Mar;40(3):606-15. doi: 10.1111/acer.12980. Epub 2016 Feb 25.

    PMID: 26916879DERIVED

  • Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, Vandrey RG, al'Absi M, Carmella SG, Cinciripini PM, Dermody SS, Drobes DJ, Hecht SS, Jensen J, Lane T, Le CT, McClernon FJ, Montoya ID, Murphy SE, Robinson JD, Stitzer ML, Strasser AA, Tindle H, Hatsukami DK. Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J Med. 2015 Oct;373(14):1340-9. doi: 10.1056/NEJMsa1502403.

    PMID: 26422724DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Eric C Donny, PhD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 10, 2012

Study Start

June 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(9)