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Trial record 1 of 1 for:    Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
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Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

This study is currently recruiting participants.
Verified July 2017 by Jonathan Foulds, Milton S. Hershey Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01928758
First Posted: August 27, 2013
Last Update Posted: July 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jonathan Foulds, Milton S. Hershey Medical Center
  Purpose

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 mg to 0.3 mg over 6 months.

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 Intervention
Tobacco Dependence Drug: Reduced Nicotine Content Cigarettes Drug: Usual Nicotine Content Cigarettes

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jonathan Foulds, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Plasma Cotinine Concentration [ Time Frame: Measured during the last 8 weeks of randomization ]
    Plasma cotinine is a measure of daily nicotine exposure


Secondary Outcome Measures:
  • Ratings of psychiatric and nicotine withdrawal symptoms [ Time Frame: Measured in the last 8 weeks of the study ]

    Quick Inventory of Depressive Symptomatology

    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



Other Outcome Measures:
  • 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


Estimated Enrollment: 280
Study Start Date: September 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced Nicotine Content Cigarettes
The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.5, 8.6, 4.0, 1.8, 0.9 and 0.3 mg per cigarette) cigarettes, with each nicotine level smoked for 4 weeks, except the lowest level which continues for 8 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 matching the nicotine content of the participant's preferred brand of cigarettes (around 11.5mg)
Drug: Usual Nicotine Content Cigarettes
Usual Nicotine Content Cigarettes
Other Name: Nicotine

Detailed Description:

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.

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 mg to 0.3 mg over 6 months. All subjects will participate in leadin 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 MGH 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 on a monthly basis, 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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 COPD 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
  Contacts and Locations
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


Contacts
Contact: Susan Veldheer, MS 844-207-6392 contactP2@phs.psu.edu
Contact: Robinn Moyer 844-207-6392 contactP2@phs.psu.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02199
Contact: Gladys Pachas    617-643-1991    gpachas1@mgh.harvard.edu   
Contact: Christie Yunyao Wu    617-643-5926    ywu20@mgh.harvard.edu   
Principal Investigator: A. Eden Evins, MD, MPH         
United States, Pennsylvania
Penn State College of Medicine Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Jonathan Foulds, PhD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Jonathan A Foulds, PhD Penn State College of Medicine
Principal Investigator: A. Eden Evins, MD, MPH Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan Foulds, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01928758     History of Changes
Other Study ID Numbers: 43804UG-P2
P50DA036107-01 ( U.S. NIH Grant/Contract )
First Submitted: August 21, 2013
First Posted: August 27, 2013
Last Update Posted: July 6, 2017
Last Verified: July 2017
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:
Anxiety Disorders
Tobacco Use Disorder
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