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Nicotine DependencePhase 3NCT01892813

Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

A Phase 3 study testing Nicotine replacement therapy - Transdermal nicotine patch, Nicotine replacement therapy - Nicotine gum and Nicotine replacement therapy - Nicotine lozenge in people with Nicotine Dependence and Tobacco Use, run by Mark Vander Weg at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances… Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Nicotine Dependence, Tobacco Use
What is being tested?
Nicotine replacement therapy - Transdermal nicotine patch, Nicotine replacement therapy - Nicotine gum and Nicotine replacement therapy - Nicotine lozenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
1 siteUnited States
Study dates
Jul 2013to Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

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 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veteran status
  • 18 + years of age
  • Smoke cigarettes on at least a daily basis
  • Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
  • Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
  • Be willing to make an attempt to quit smoking in the next 30 days
Show all 9Show fewer
  • Be capable of providing informed consent
  • Have access to a telephone (land line or cell phone)
  • Have a stable residence

Who cannot join

  • Planning to move within the next 12 months
  • Presence of a terminal illness
  • Pregnancy
  • Unstable psychiatric disorder (e.g., acute psychosis)
  • Currently pregnant
  • Incarcerated
  • Institutionalized

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Iowa City VA Healthcare System

    Iowa City, Iowa, 52246

Other trials in United States

About this study

Official title: Tailored Tobacco Intervention

The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.

Being tested
Nicotine replacement therapy - Transdermal nicotine patch, Nicotine replacement therapy - Nicotine gum, Nicotine replacement therapy - Nicotine lozenge, Bupropion, Varenicline
Keywords
Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight
Medical subject headings
Tobacco Use Disorder, Tobacco Use, Smoking Cessation, Alcohol Drinking, Depression, Body Weight

What participants receive

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

  • Nicotine replacement therapy - Transdermal nicotine patchDrug

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • Nicotine replacement therapy - Nicotine gumDrug

    Also called Nicotine polacrilix

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • Nicotine replacement therapy - Nicotine lozengeDrug

    Also called Nicotine polacrilix

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • BupropionDrug

    Also called Zyban

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • VareniclineDrug

    Also called Chantix

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • Combination pharmacotherapy - Transdermal nicotine patch + nicotine gumDrug

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozengeDrug

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • Combination pharmacotherapy - Transdermal nicotine patch + bupropionDrug

    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

  • Tobacco quitline referralBehavioural

    Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.

  • Tailored behavioral interventionBehavioural

    Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.

  • Alcohol use risk reductionBehavioural

    Also called Harm reduction

    Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.

  • Behavioral activation for depressive symptomsBehavioural

    Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.

  • Behavioral management of postcessation weight gainBehavioural

    Also called Weight management

    Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.

Study groups in NCT01892813
Study groupRoleWhat they receive
Tailored interventionExperimentalParticipants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
Receives: Drug: Nicotine replacement therapy - Transdermal nicotine patch; Drug: Nicotine replacement therapy - Nicotine gum; Drug: Nicotine replacement therapy - Nicotine lozenge; Drug: Bupropion; Drug: Varenicline; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge; Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion; Behavioral: Tailored behavioral intervention; Behavioral: Alcohol use risk reduction; Behavioral: Behavioral activation for depressive symptoms; Behavioral: Behavioral management of postcessation weight gain
Enhanced standard of careActive comparatorParticipants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
Receives: Drug: Nicotine replacement therapy - Transdermal nicotine patch; Drug: Nicotine replacement therapy - Nicotine gum; Drug: Nicotine replacement therapy - Nicotine lozenge; Drug: Bupropion; Drug: Varenicline; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge; Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion; Behavioral: Tobacco quitline referral

What is being measured

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

  1. Tobacco use

    At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.

    Measured: Six-month follow-up

Secondary outcomes (5)

  1. Alcohol use

    Alcohol use during the previous seven days will be assessed at the six month follow-up. Based on this information, several metrics of alcohol consumption will be obtained including: 1) average number of drinking days per week, 2) average number of drinks per drinking day, 3) number of drinks per week 4) number of heavy drinking days, and 5) maximum drinks consumed on a single occasion.

    Measured: Six-month follow-up

  2. Depressive symptoms

    Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).

    Measured: Six-month follow-up

  3. Body weight

    Change in body weight will be assessed via self-report and chart review at the six-month follow-up.

    Measured: Six-month follow-up

  4. Physical Activity

    Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA).

    Measured: Six-month follow-up

  5. Dietary intake

    Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.

    Measured: Six-month follow-up

Timeline

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

  1. First posted4 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2018 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01892813
Sponsor's protocol ID
201305740
Status last verified
Jul 2017
First submitted
1 Jul 2013
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PubMed 37142273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine replacement therapy - Transdermal nicotine patch, Nicotine replacement therapy - Nicotine gum and Nicotine replacement therapy - Nicotine lozenge in people with Nicotine Dependence and Tobacco Use, run by Mark Vander Weg at 1 site 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Tobacco use (time frame: Six-month follow-up). 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 NCT01892813, which also lists 1 linked publication.

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 11 Jul 2017.

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