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Smokeless TobaccoNCT02994082

Treating Smokeless Tobacco Use in Rural Veterans

A study testing Tailored behavioral intervention, Behavioral activation for elevated depressive symptoms and Post-cessation weight gain management in people with Smokeless Tobacco and Nicotine Dependence, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues… Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Smokeless Tobacco, Nicotine Dependence
What is being tested?
Tailored behavioral intervention, Behavioral activation for elevated depressive symptoms and Post-cessation weight gain management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteUnited States
Study dates
Dec 2016to May 2020
Phase
Interventional
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

  • Use smokeless tobacco on a daily basis
  • Be willing to make a quit attempt in the next 30 days
  • Reside in a rural location
  • Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
  • Able to provide informed consent
  • Telephone access
  • Stable residence

Who cannot join

  • Planning to move in the next 12 months
  • Terminal illness
  • Unstable psychiatric disorder
  • 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

This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to:

  1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
  2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.
Being tested
Tailored behavioral intervention, Behavioral activation for elevated depressive symptoms, Post-cessation weight gain management, Alcohol use risk reduction, Nicotine replacement therapy - transdermal nicotine patch
Keywords
Rural health, Veterans, Smokeless tobacco cessation
Medical subject headings
Tobacco Use, Tobacco Use Disorder, Tobacco Use Cessation

What participants receive

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

  • Tailored behavioral interventionBehavioural

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

  • Behavioral activation for elevated depressive symptomsBehavioural

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

  • Post-cessation weight gain managementBehavioural

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

  • Alcohol use risk reductionBehavioural

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

  • Nicotine replacement therapy - transdermal nicotine patchDrug

    Also called Nicotine patch

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

  • Nicotine replacement therapy - nicotine lozengeDrug

    Also called Nicotine lozenge

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

  • Nicotine replacement therapy - nicotine gumDrug

    Also called Nicotine gum

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

  • Bupropion sustained releaseDrug

    Also called Zyban

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

  • VareniclineDrug

    Also called Chantix

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

  • Combination nicotine replacement therapyDrug

    Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.

  • Combination nicotine replacement therapy + bupropionDrug

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

    Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.

  • Tobacco quit lineBehavioural

    Referral to the Department of Veterans Affairs tobacco telephone quit line.

  • Educational materialsBehavioural

    Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,

Study groups in NCT02994082
Study groupRoleWhat they receive
Tailored InterventionExperimentalThe tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.
Receives: Behavioral: Tailored behavioral intervention; Behavioral: Behavioral activation for elevated depressive symptoms; Behavioral: Post-cessation weight gain management; Behavioral: Alcohol use risk reduction; Drug: Nicotine replacement therapy - transdermal nicotine patch; Drug: Nicotine replacement therapy - nicotine lozenge; Drug: Nicotine replacement therapy - nicotine gum; Drug: Bupropion sustained release; Drug: Varenicline; Drug: Combination nicotine replacement therapy; Drug: Combination nicotine replacement therapy + bupropion
Facilitated tobacco quit line referralActive comparatorParticipants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.
Receives: Behavioral: Tobacco quit line; Behavioral: Educational materials

What is being measured

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

  1. Treatment satisfaction

    Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.

    Measured: Three month follow-up

Secondary outcomes (7)

  1. Tobacco use

    At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.

    Measured: Three-and six-month follow-up

  2. Alcohol use

    Alcohol use during the previous seven days.

    Measured: Three- and six-month follow-up

  3. Depressive symptoms

    Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)

    Measured: Three- and six-month follow-up

  4. Body weight

    Body weight will be assessed via self-report.

    Measured: Three- and six-month follow-up

  5. Enrollment rate

    The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.

    Measured: Six months after study initiation

  6. Retention

    The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.

    Measured: Six months after study initiation

  7. Treatment attendance

    The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.

    Measured: Three-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 posted15 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionSep 2019 (estimated)
  4. Study completionMay 2020 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994082
Sponsor's protocol ID
201611737
Status last verified
Jul 2019
First submitted
8 Dec 2016
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tailored behavioral intervention, Behavioral activation for elevated depressive symptoms and Post-cessation weight gain management in people with Smokeless Tobacco and Nicotine Dependence, 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 7 inclusion and 5 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 24 Jul 2019. 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.

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?

Treatment satisfaction (time frame: Three 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 NCT02994082.

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 24 Jul 2019.

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