Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
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| ClinicalTrials.gov Identifier: NCT01928758 |
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Recruitment Status :
Completed
First Posted : August 27, 2013
Results First Posted : February 8, 2019
Last Update Posted : June 28, 2019
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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 |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Reduced Nicotine Content Cigarettes
Research cigarettes will have gradually reduced nicotine content
Other Name: Nicotine |
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Placebo Comparator: Usual Nicotine Content Cigarettes
Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)
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Drug: Usual Nicotine Content Cigarettes
Usual Nicotine Content Cigarettes
Other Name: Nicotine |
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02199 | |
| United States, Pennsylvania | |
| Penn State College of Medicine | |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: | Jonathan A Foulds, PhD | Penn State College of Medicine | |
| Principal Investigator: | A. Eden Evins, MD, MPH | Massachusetts General Hospital |
Documents provided by Jonathan Foulds, Milton S. Hershey Medical Center:
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 |
| 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 |
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Smoking Nicotine |
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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 |