CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Nicotine replacement therapy - transdermal nicotine patch +12 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01592695
NCT01592695Phase 2Completed

Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity

Iowa City Veterans Affairs Medical Center·interventional·Posted May 7, 2012·Updated Aug 2, 2019

In Brief

A Phase 2 clinical trial evaluating Nicotine replacement therapy - transdermal nicotine patch, Tailored behavioral intervention, and 11 other interventions for Cigarette Smoking. Completed, enrolled 63 participants across 1 site.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2012
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.2 years ago

Interventions

Nicotine replacement therapy - transdermal nicotine patchdrug

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

Tailored behavioral interventionbehavioral

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

Tobacco quit line referralbehavioral

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.

Nicotine replacement therapy - nicotine gumdrug

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

Nicotine replacement therapy - nicotine lozengedrug

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

Bupropion Sustained Releasedrug

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

Vareniclinedrug

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

Alcohol use risk reductionbehavioral

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

Behavioral activation for the treatment of depressionbehavioral

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

Behavioral management of post-cessation weight gainbehavioral

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.