Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

Tobacco Dependence Clinical Trial

Official title:

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928758
• Other study ID #: STUDY911
• Secondary ID: P50DA036107
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 23, 2018

Study information

• Verified date: June 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: March 23, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Reduced Nicotine Content Cigarettes
Research cigarettes will have gradually reduced nicotine content
• Usual Nicotine Content Cigarettes
Usual Nicotine Content Cigarettes

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Allen SI, Foulds J, Pachas GN, Veldheer S, Cather C, Azzouz N, Hrabovsky S, Hameed A, Yingst J, Hammett E, Modesto J, Krebs NM, Zhu J, Liao J, Muscat JE, Richie J, Evins AE. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol. BMC Public Health. 2017 Jan 19;17(1):100. doi: 10.1186/s12889-016-3946-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intention to Quit Smoking	Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking	At end of 18-week randomized trial phase
Other	Abstinence From Smoking	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.	Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).
Primary	Plasma Cotinine Concentration	Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.	Measured at the end of the last 3 weeks of randomization trial phase
Secondary	Quick Inventory of Depressive Symptomatology	A 16-item scale on depression symptoms. The scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.	Measured at the end of the last 3 weeks of randomization trial phase
Secondary	Perceived Stress Scale	10-item questionnaire measuring the degree to which life situations are appraised stressful. Scale range is 0-40. Higher scores indicate more stress.	Measured at the end of the last 3 weeks of randomization trial phase
Secondary	Minnesota Nicotine Withdrawal Scale	This 8-item scale measures nicotine withdrawal symptoms and the scale range is from 0-32. Higher scores indicate higher severity.	Measured at the end of the last 3 weeks of randomization trial phase