Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

Not Applicable

Completed

Conditions: Tobacco Dependence

Interventions: Drug: Reduced Nicotine Content Cigarettes
Drug: Usual Nicotine Content Cigarettes

Registration Number: NCT01928758

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 245

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced Nicotine Content Cigarettes	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
Usual Nicotine Content Cigarettes	Usual Nicotine Content Cigarettes	Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)

Primary Outcome Measures

Name	Time	Method
Plasma Cotinine Concentration	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

Name	Time	Method
Perceived Stress Scale	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.
Quick Inventory of Depressive Symptomatology	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.
Minnesota Nicotine Withdrawal Scale	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.

Trial Locations

Locations (2): Massachusetts General Hospital
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Boston, Massachusetts, United States
Penn State College of Medicine
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Hershey, Pennsylvania, United States