Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Previous Study | Return to List | Next Study

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: Reduced Nicotine Content Cigarettes Drug: Usual Nicotine Content Cigarettes Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Study Start Date : September 2015
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : March 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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
Drug: Reduced Nicotine Content Cigarettes
Research cigarettes will have gradually reduced nicotine content
Other Name: Nicotine

Placebo Comparator: Usual Nicotine Content Cigarettes
Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)
Drug: Usual Nicotine Content Cigarettes
Usual Nicotine Content Cigarettes
Other Name: Nicotine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928758


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02199
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Jonathan A Foulds, PhD Penn State College of Medicine
Principal Investigator: A. Eden Evins, MD, MPH Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Jonathan Foulds, Milton S. Hershey Medical Center:
Publications:
Layout table for additonal information
Responsible Party: Jonathan Foulds, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01928758    
Other Study ID Numbers: STUDY911
P50DA036107 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2013    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonathan Foulds, Milton S. Hershey Medical Center:
Smoking
Nicotine
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Anxiety Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action