Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes

NCT02301325 | Completed DMC

• 2 other identifiers: U54 DA031659-P1S21U54DA031659-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and without transdermal nicotine on 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, cue reactivity, cardiovascular function, perceived risk and cue reactivity. The investigators will also consider differences between conditions in compliance with product use and the ability to abstain from smoking when provided a financial incentive for abstinence.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Cigarettes Smoked Per Day

  Six Weeks

Study Arms (4)

0.03 mg Nicotine Cigarette

OTHER

Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes

Behavioral: Smoking research cigarettes with or without NRT

0.03 mg Nicotine Cigarette and NRT

OTHER

Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes and use nicotine replacement patches.

Behavioral: Smoking research cigarettes with or without NRT

0.80 mg Nicotine Cigarette

OTHER

Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes.

Behavioral: Smoking research cigarettes with or without NRT

0.80 mg Nicotine Cigarette and NRT

OTHER

Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes and use nicotine replacement patches.

Behavioral: Smoking research cigarettes with or without NRT

Interventions

Smoking research cigarettes with or without NRT BEHAVIORAL

0.03 mg Nicotine Cigarette; 0.03 mg Nicotine Cigarette and NRT; 0.80 mg Nicotine Cigarette; 0.80 mg Nicotine Cigarette and NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days.
• Breath CO levels \> or = 10 ppm (if \< 10 ppm, then NicAlert Strip = 6)
• Fulfills need for participants in the required strata (menthol status)

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)
• Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
• 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)
• Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional)
• Schizophrenia and schizoaffective disorder
• Positive toxicology screen for any of the following drugs: marijuana, cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
• Participants with valid prescriptions for any toxicology results will not be excluded.
• Breath alcohol level \> 0.01
• Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male))
• Pregnant, trying to become pregnant or breastfeeding
• Smoking 'roll your own cigarettes' exclusively

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Smith TT, Koopmeiners JS, Tessier KM, Davis EM, Conklin CA, Denlinger-Apte RL, Lane T, Murphy SE, Tidey JW, Hatsukami DK, Donny EC. Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine. Am J Prev Med. 2019 Oct;57(4):515-524. doi: 10.1016/j.amepre.2019.05.010.

  PMID: 31542129 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Eric Donny, Ph.D.

  Professor, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)