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Tobacco DependenceNCT01928758

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

A study testing Reduced Nicotine Content Cigarettes and Usual Nicotine Content Cigarettes in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco Dependence
What is being tested?
Reduced Nicotine Content Cigarettes and Usual Nicotine Content Cigarettes
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
245 participants
Where
2 sitesUnited States
Study dates
Sep 2015to 23 Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02199

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Read the 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.

Being tested
Reduced Nicotine Content Cigarettes, Usual Nicotine Content Cigarettes
Keywords
Smoking, Nicotine
Medical subject headings
Tobacco Use Disorder, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduced Nicotine Content CigarettesDrug

    Also called Nicotine

    Research cigarettes will have gradually reduced nicotine content

  • Usual Nicotine Content CigarettesDrug

    Also called Nicotine

    Usual Nicotine Content Cigarettes

Study groups in NCT01928758
Study groupRoleWhat they receive
Reduced Nicotine Content CigarettesExperimentalThe 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
Receives: Drug: Reduced Nicotine Content Cigarettes
Usual Nicotine Content CigarettesPlacebo comparatorResearch cigarettes with a usual nicotine content (around 11.6mg per cigarette)
Receives: Drug: Usual Nicotine Content Cigarettes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Cotinine Concentration

    Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.

    Measured: Measured at the end of the last 3 weeks of randomization trial phase

Secondary outcomes (3)

  1. 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: Measured at the end of the last 3 weeks of randomization trial phase

  2. 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: Measured at the end of the last 3 weeks of randomization trial phase

  3. 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: Measured at the end of the last 3 weeks of randomization trial phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2013 (estimated)
  2. Study startSep 2015
  3. Primary completion11 Jan 2018
  4. Study completion23 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01928758
Sponsor's protocol ID
STUDY911
Other IDs
P50DA036107
Status last verified
Jun 2019
First submitted
21 Aug 2013
Last updated
28 Jun 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28103841

  • Foulds J, Veldheer S, Pachas G, Hrabovsky S, Hameed A, Allen SI, Cather C, Azzouz N, Yingst J, Hammett E, Modesto J, Krebs NM, Lester C, Trushin N, Reinhart L, Wasserman E, Zhu J, Liao J, Muscat JE, Richie JP Jr, Evins AE. The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trial. PLoS One. 2022 Nov 2;17(11):e0275522. doi: 10.1371/journal.pone.0275522. eCollection 2022.

    PubMed 36322562

Questions about this trial

What is this clinical trial studying?

A study testing Reduced Nicotine Content Cigarettes and Usual Nicotine Content Cigarettes in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Cotinine Concentration (time frame: Measured at the end of the last 3 weeks of randomization trial phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01928758, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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