Tailored Tobacco Quitline for Rural Veterans

NCT01592695 | Completed Phase 2 Results

• 1 other identifier: 201203712
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:

1. 1.Study the feasibility of an individually-tailored telephone intervention for rural smokers.
2. 2.Examine the impact of the intervention on tobacco use outcomes.
3. 3.Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Conditions

Cigarette Smoking

Keywords

Nicotine dependence; Smoking cessation; Telehealth; Alcohol use; Depression; Body weight

Outcome Measures

Primary Outcomes (1)

• Treatment Satisfaction

  Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.

  End of treatment (seven weeks after baseline)

Secondary Outcomes (7)

• Number of Participants Abstinent From Tobacco Use

  Six-month follow-up

• Alcohol Use

  Six-month follow-up

• Depressive Symptoms

  Six-month follow-up

• Body Weight

  Six-month follow-up

• Enrollment Rate

  6 months after study initiation

Study Arms (2)

Tailored Intervention Group

EXPERIMENTAL

Participants 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 associated with cigarette smoking.

Drug: Nicotine replacement therapy - transdermal nicotine patch; Behavioral: Tailored behavioral intervention; Drug: Nicotine replacement therapy - nicotine gum; Drug: Nicotine replacement therapy - nicotine lozenge; Drug: Bupropion Sustained Release; 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: Alcohol use risk reduction; Behavioral: Behavioral activation for the treatment of depression; Behavioral: Behavioral management of post-cessation weight gain

Enhanced Standard of Care Group

ACTIVE COMPARATOR

Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.

Drug: Nicotine replacement therapy - transdermal nicotine patch; Behavioral: Tobacco quit line referral; Drug: Nicotine replacement therapy - nicotine gum; Drug: Nicotine replacement therapy - nicotine lozenge; Drug: Bupropion Sustained Release; 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

Interventions

Nicotine replacement therapy - transdermal nicotine patch DRUG

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

Enhanced Standard of Care Group; Tailored Intervention Group

Tailored behavioral intervention BEHAVIORAL

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

Tailored Intervention Group

Tobacco quit line referral BEHAVIORAL

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

Enhanced Standard of Care Group

Nicotine replacement therapy - nicotine gum DRUG

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

Enhanced Standard of Care Group; Tailored Intervention Group

Nicotine replacement therapy - nicotine lozenge DRUG

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

Enhanced Standard of Care Group; Tailored Intervention Group

Bupropion Sustained Release DRUG

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

Also known as: Zyban

Enhanced Standard of Care Group; Tailored Intervention Group

Varenicline DRUG

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

Also known as: Chantix

Enhanced Standard of Care Group; Tailored Intervention Group

Combination pharmacotherapy - transdermal nicotine patch + nicotine gum DRUG

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

Enhanced Standard of Care Group; Tailored Intervention Group

Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge DRUG

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

Enhanced Standard of Care Group; Tailored Intervention Group

Combination pharmacotherapy - transdermal nicotine patch + bupropion DRUG

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

Enhanced Standard of Care Group; Tailored Intervention Group

Alcohol use risk reduction BEHAVIORAL

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

Also known as: Risky alcohol use, Harm reduction

Tailored Intervention Group

Behavioral activation for the treatment of depression BEHAVIORAL

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

Also known as: Depression

Tailored Intervention Group

Behavioral management of post-cessation weight gain BEHAVIORAL

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.

Also known as: Weight management

Tailored Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a veteran
• + years of age
• Smoke cigarettes on at least a daily basis
• Receive primary care from the Iowa City VAMC or Coralville Clinic
• Live in a non-metropolitan area (based on RUCA codes)
• Be willing to make a quit attempt in the next 30 days
• Be capable of providing informed consent
• Have access to a telephone (land line or cell phone)
• Have a stable residence

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa City Veterans Affairs Medical Center: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Iowa City VA Health Care System

Iowa City, Iowa, 52246, United States

Location

Related Publications (2)

• Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.

  PMID: 27535024 RESULT

• 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.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder; Smoking Cessation; Alcohol Drinking; Depression; Body Weight

Interventions

Bupropion; Varenicline; Nicotine Chewing Gum; Tobacco Use Cessation Devices; Ethanol

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Drinking Behavior; Behavioral Symptoms; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols

Results Point of Contact

• Title: Mark Vander Weg, PhD
• Organization: University of Iowa

mark-vanderweg@uiowa.edu

319-338-0581

Study Officials

• Mark VanderWeg, PhD

  VRHRC-CR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Specialist

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: May 7, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 2, 2019
• Results First Posted: July 19, 2017

Record last verified: 2019-07

Locations

US (1)