Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

Completed · Not applicable

Conditions studied: Tobacco Dependence

In brief

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.

Key facts

Study ID

NCT01928758

Run by

Milton S. Hershey Medical Center

People needed

245

Starts

2015-09-01

Expected to finish

2018-03-23

Last updated by the study team

2019-06-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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