Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-03-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

NCT03612960

Tobacco Dependence

COMPLETED NA

Treating Smokers With Mental Illness

NCT03822416

Smoking Cessation Cigarette Smoking Schizophrenia +5 more

COMPLETED PHASE2

Low Nicotine Cigarettes Plus Electronic Cigarettes

NCT04058717

Tobacco Dependence

COMPLETED NA

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

NCT01522963

Tobacco Use Disorder

COMPLETED NA

Manipulating Tobacco Constituents in Female Menthol Smokers

NCT02048852

Nicotine Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Reduced Nicotine Content Cigarettes

Intervention Type DRUG

Research cigarettes will have gradually reduced nicotine content

Usual Nicotine Content Cigarettes

Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)

Group Type PLACEBO_COMPARATOR

Usual Nicotine Content Cigarettes

Intervention Type DRUG

Usual Nicotine Content Cigarettes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reduced Nicotine Content Cigarettes

Research cigarettes will have gradually reduced nicotine content

Intervention Type DRUG

Usual Nicotine Content Cigarettes

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nicotine Nicotine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes