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Durham, North Carolina 27705


Purpose:

This study is designed to test an adaptive pharmacotherapy algorithm within the Duke Smoking Cessation Program (DSCP). The investigators hypothesize that patients treated in the DSCP with Algorithm-based pharmacotherapy vs. Varenicline will show significantly higher 12-week post-quit 30-day continuous abstinence.


Study summary:

This research study is a cross-randomized, placebo-controlled trial to evaluate an algorithm-based pharmacotherapy approach to treating tobacco use ('Algorithm') and the efficacy of a high intensity behavioral treatment in comparison to the standard of care. The Algorithm is designed to assist clinicians in identifying the appropriate pharmacotherapy and behavioral interventions to treat tobacco use and to provide additional medications to individuals who do not decrease tobacco use following two weeks of pre-quit pharmacotherapy ('Non-Responders'). The population group is recruited from patients being seen at the Duke Smoking Cessation Program. Outcomes of abstinence variables will be analyzed using general regression models using an ANOVA-based design; randomization status to both pharmacotherapy and behavioral groups will be denoted using a proxy variable to test primary study effects. An alpha criterion of 0.05 (two-tailed) will be used in all comparisons. Risk for the study is low as all pharmacotherapies being evaluated are FDA-approved for tobacco use treatment.


Criteria:

Participants being screened are being treated at the Translational Smoking Cessation Program (TSCP). Practically speaking, however, the TSCP will only be treating patients who have self-reported as smokers, who are 18 years of age or older, and who would like to quit smoking. Inclusion Criteria: 1. Patient being treated at DSCP for tobacco use 2. Age 18 years or older 3. Actively smoking 5 or more cigarettes per day for at least one year 4. Fluency in spoken and written English 5. Willing to set a quit date within 6 weeks 6. Access to a telephone 7. Willingness to attend 7 weeks (24 hours) of group therapy on specific offered dates. 8. Willingness to take Varenicline, Bupropion and Nicotine Patch. Exclusion Criteria: 1. CO test under 7 ppm 2. 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10) 3. 6 or above on Drug Abuse Screening Test (DAST-10) 4. 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale 5. Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff) 6. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion) 7. Intolerable side effects related to, refusal to take, or medical contraindication to the use of Varenicline, nicotine patch, or Bupropion. 8. Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, anxiety. This is determined by clinical assessment. 9. Disruptive behavior toward staff. Because subjects are requested to engage in group behavioral treatment, this criterion is for the protection of other participants within group treatment. 10. Report of pregnancy, attempting to get pregnant, or actively breast feeding. 11. Positive urine pregnancy test (only given to females with child bearing potential)


NCT ID:

NCT02501265


Primary Contact:

Principal Investigator
James M Davis, M.D.
Duke University

Jillian Dirkes, MSW
Phone: 919-668-3842
Email: jillian.dirkes@duke.edu


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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