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Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT01928758
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : February 8, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jonathan Foulds, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE August 21, 2013
First Posted Date  ICMJE August 27, 2013
Results First Submitted Date  ICMJE January 11, 2019
Results First Posted Date  ICMJE February 8, 2019
Last Update Posted Date June 28, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
Plasma Cotinine Concentration [ Time Frame: Measured at the end of the last 3 weeks of randomization trial phase ]
Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Plasma Cotinine Concentration [ Time Frame: Measured during the last 8 weeks of randomization ]
Plasma cotinine is a measure of daily nicotine exposure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • Quick Inventory of Depressive Symptomatology [ Time Frame: Measured at the end of the last 3 weeks of randomization trial phase ]
    A 16-item scale on depression symptoms. The scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.
  • Perceived Stress Scale [ Time Frame: Measured at the end of the last 3 weeks of randomization trial phase ]
    10-item questionnaire measuring the degree to which life situations are appraised stressful. Scale range is 0-40. Higher scores indicate more stress.
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Measured at the end of the last 3 weeks of randomization trial phase ]
    This 8-item scale measures nicotine withdrawal symptoms and the scale range is from 0-32. Higher scores indicate higher severity.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Ratings of psychiatric and nicotine withdrawal symptoms [ Time Frame: Measured in the last 8 weeks of the study ]
The Hospital Anxiety and Depression Scale will be completed at regular intervals throughout the study and will be the primary measure of depression and anxiety symptoms The Profile of Moods Scale (POMS) is a widely used measure of mood states Perceived Stress Questionnaire is a 14-item form measuring the degree to which life situations are appraised as stressful The Minnesota Nicotine Withdrawal Scale measures nicotine withdrawal symptoms
Current Other Pre-specified Outcome Measures
 (submitted: January 11, 2019)
  • Intention to Quit Smoking [ Time Frame: At end of 18-week randomized trial phase ]
    Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking
  • Abstinence From Smoking [ Time Frame: Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase). ]
    Smokers assigned to reduced nicotine content cigarettes will be more likely to successfully abstain from smoking at the end of the trial, based on all randomized participants, defined as no cigarette use in past 7 days, verified by exhaled carbon monoxide <10ppm.
Original Other Pre-specified Outcome Measures
 (submitted: August 21, 2013)
Intention to Quit Smoking [ Time Frame: Last 8 weeks of the study ]
Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking
 
Descriptive Information
Brief Title  ICMJE Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Official Title  ICMJE Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
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.

Detailed Description

The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders.

To do so, we will randomly assign 200 adult smokers with a unipolar mood and/or anxiety disorder within the past year to smoke research cigarettes that will contain either a) Usual Nicotine Content (UNC): nicotine content similar to their preferred usual brand of cigarettes, or b) Reduced Nicotine Content (RNC): nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. All subjects will participate in baseline periods prior to double-blind randomization to assess normal smoking behavior and then to establish ability to tolerate research cigarettes prior to randomization.

A total of 280 participants will be enrolled in the study at two sites with the aim of randomizing 200 who complete the baseline phase. 100 participants will be enrolled in the randomized phase at Penn State Hershey and 100 at the Massachusetts General Hospital site. Participants will be started on the study protocol during Baseline I and Baseline II but will be removed from the study if they are not able to comply with the protocol. We expect that approximately 40 participants at each site drop out from the study prior to randomization (due to inability to comply with study protocol).

It is our hypothesis that nicotine intake, as measured by plasma cotinine concentration, will decline as a function of cigarette nicotine content in the RNC group. Further, it is our hypothesis that by gradually reducing the nicotine content of the cigarettes in a step-wise fashion, there will not be significant increases in biomarkers of tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the experimental group (RNC) as compared with the UNC control group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE
  • Drug: Reduced Nicotine Content Cigarettes
    Research cigarettes will have gradually reduced nicotine content
    Other Name: Nicotine
  • Drug: Usual Nicotine Content Cigarettes
    Usual Nicotine Content Cigarettes
    Other Name: Nicotine
Study Arms  ICMJE
  • Experimental: Reduced Nicotine Content Cigarettes
    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
    Intervention: Drug: Reduced Nicotine Content Cigarettes
  • Placebo Comparator: Usual Nicotine Content Cigarettes
    Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)
    Intervention: Drug: Usual Nicotine Content Cigarettes
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2019)
245
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2013)
200
Actual Study Completion Date  ICMJE March 23, 2018
Actual Primary Completion Date January 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01928758
Other Study ID Numbers  ICMJE STUDY911
P50DA036107 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Foulds, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Jonathan A Foulds, PhD Penn State College of Medicine
Principal Investigator: A. Eden Evins, MD, MPH Massachusetts General Hospital
PRS Account Milton S. Hershey Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP