Tailored Tobacco Quitline for Rural Veterans
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Purpose
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:
- Study the feasibility of an individually-tailored telephone intervention for rural smokers.
- Examine the impact of the intervention on tobacco use outcomes.
- Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.
| Condition | Intervention | Phase |
|---|---|---|
|
Cigarette Smoking |
Drug: Nicotine replacement therapy - transdermal nicotine patch Behavioral: Tailored behavioral intervention Behavioral: Tobacco quitline referral Drug: Nicotine replacement therapy - nicotine gum Drug: Nicotine replacement therapy - nicotine lozenge Drug: Bupropion SR 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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity |
- Treatment satisfaction [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
- Tobacco use [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence) and any use of tobacco following an initial two-week grace period following the planned quit date (prolonged abstinence).
- Alcohol use [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module. 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.
- Depressive symptoms [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]Depressive symptoms will be assessed among participants who receive the depression treatment using the Patient Health Questionnaire 9 (PHQ-9).
- Body weight [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]Change in body weight following smoking cessation will be assessed via self-report and chart review among those receiving the weight management treatment module.
- Enrollment rate [ Time Frame: 6 months after study initiation ] [ Designated as safety issue: No ]The number of participants enrolled each month will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.
- Retention [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]The proportion of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.
- Treatment attendance [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tailored Intervention Group
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
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Behavioral: Tailored behavioral intervention
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
Drug: Nicotine replacement therapy - nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Nicotine replacement therapy - nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Bupropion SR
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Other Name: Zyban
Drug: Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Other Name: Chantix
Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Behavioral: Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Other Names:
Behavioral: Behavioral activation for the treatment of depression
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Other Name: Depression
Behavioral: Behavioral management of post-cessation weight gain
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.
Other Name: Weight management
|
|
Active Comparator: Enhanced Standard of Care Group
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
|
Drug: Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Behavioral: Tobacco quitline referral
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.
Drug: Nicotine replacement therapy - nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Nicotine replacement therapy - nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Bupropion SR
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Other Name: Zyban
Drug: Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Other Name: Chantix
Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
|
Detailed Description:
Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.
Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.
In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Being a veteran
- 18 + 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
Exclusion Criteria:
- 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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01592695 History of Changes |
| Other Study ID Numbers: | N32-FY12Q1-S1-P00005 |
| Study First Received: | April 11, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Nicotine dependence Smoking cessation Telehealth |
Alcohol use Depression Body weight |
Additional relevant MeSH terms:
|
Smoking Habits Ethanol Nicotine polacrilex Bupropion Nicotine Varenicline Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Ganglionic Stimulants |
Autonomic Agents Peripheral Nervous System Agents Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013