NCT01928758

Brief Summary

The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain either a) nicotine content similar to their preferred usual brand of cigarettes, or b) nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine content in the Reduced Nicotine Content group without significant increases in tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the Reduced Nicotine Content group as compared with the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 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 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

August 21, 2013

Results QC Date

January 11, 2019

Last Update Submit

June 19, 2019

Conditions

Tobacco Dependence

Keywords

SmokingNicotine

Outcome Measures

Primary Outcomes (1)

  • Plasma Cotinine Concentration

    Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.

    Measured at the end of the last 3 weeks of randomization trial phase

Secondary Outcomes (3)

  • Quick Inventory of Depressive Symptomatology

    Measured at the end of the last 3 weeks of randomization trial phase

  • Perceived Stress Scale

    Measured at the end of the last 3 weeks of randomization trial phase

  • Minnesota Nicotine Withdrawal Scale

    Measured at the end of the last 3 weeks of randomization trial phase

Other Outcomes (2)

  • Intention to Quit Smoking

    At end of 18-week randomized trial phase

  • Abstinence From Smoking

    Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).

Study Arms (2)

Reduced Nicotine Content Cigarettes

EXPERIMENTAL

The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks

Drug: Reduced Nicotine Content Cigarettes

Usual Nicotine Content Cigarettes

PLACEBO COMPARATOR

Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)

Drug: Usual Nicotine Content Cigarettes

Interventions

Reduced Nicotine Content CigarettesDRUG

Research cigarettes will have gradually reduced nicotine content

Also known as: Nicotine
Reduced Nicotine Content Cigarettes
Usual Nicotine Content CigarettesDRUG

Usual Nicotine Content Cigarettes

Also known as: Nicotine
Usual Nicotine Content Cigarettes

Eligibility Criteria

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

You may qualify if:

  • Smoke \>4 cigarettes/day for at least a year
  • No quit attempt in prior month
  • Not planning to quit smoking within next 6 months
  • Plan to live in local area for next 8 months
  • Meet diagnostic criteria for a current or lifetime Anxiety Disorder or Mood Disorder as determined by the Mini-international Neuropsychiatric Interview
  • Read and write in English
  • Women not pregnant or nursing and taking steps to avoid pregnancy
  • Able to understand and consent to study procedures

You may not qualify if:

  • Unstable or significant medical condition such as Chronic Obstructive Pulmonary Disease or kidney failure
  • Use of non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior month
  • Currently reducing or planning to reduce cigarette consumption in next month
  • Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the past 6 months
  • Current suicide risk on clinical assessment
  • Aged \<18 or \>65
  • History of difficulty providing blood samples (fainting, poor venous access)
  • Unwilling to remain on one flavor of cigarette (regular or menthol) for the duration of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02199, United States

Location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • Allen SI, Foulds J, Pachas GN, Veldheer S, Cather C, Azzouz N, Hrabovsky S, Hameed A, Yingst J, Hammett E, Modesto J, Krebs NM, Zhu J, Liao J, Muscat JE, Richie J, Evins AE. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol. BMC Public Health. 2017 Jan 19;17(1):100. doi: 10.1186/s12889-016-3946-4.

    PMID: 28103841BACKGROUND

  • Foulds J, Veldheer S, Pachas G, Hrabovsky S, Hameed A, Allen SI, Cather C, Azzouz N, Yingst J, Hammett E, Modesto J, Krebs NM, Lester C, Trushin N, Reinhart L, Wasserman E, Zhu J, Liao J, Muscat JE, Richie JP Jr, Evins AE. The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trial. PLoS One. 2022 Nov 2;17(11):e0275522. doi: 10.1371/journal.pone.0275522. eCollection 2022.

    PMID: 36322562DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Limitations and Caveats

The sample size was not reached due to a shortage of study cigarette inventory.

Results Point of Contact

Title
Jonathan Foulds
Organization
Penn State College of Medicine
jfoulds@psu.edu
717-531-3504

Study Officials

  • Jonathan A Foulds, PhD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

  • A. Eden Evins, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 27, 2013

Study Start

September 1, 2015

Primary Completion

January 11, 2018

Study Completion

March 23, 2018

Last Updated

June 28, 2019

Results First Posted

February 8, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)