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Smoking Cessation for Depressed Smokers

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2028v34
  2. 4 versions Re-verified since Oct 21, 2024, no change to tracked fieldsv30-v33
  3. Primary and study completion dates: Jun 30, 2024 to Jun 30, 2026 Start date: Jun 2007 to Jun 28, 2007v29 Show 1 more changeShow less
    • Start date: Jun 2007 to Jun 28, 2007
  4. Primary and study completion dates: Dec 30, 2023 to Jun 30, 2024 Enrollment target: estimated 202 to confirmed 91v28 Show 1 more changeShow less
    • Enrollment target: estimated 202 to confirmed 91
  5. Primary and study completion dates: Jun 30, 2023 to Dec 30, 2023v27
Show 25 earlier versionsHide 25 earlier versions
  1. Primary and study completion dates: Jun 2023 to Jun 30, 2023v26
  2. Re-verified, no change to tracked fieldsv25
  3. Primary and study completion dates: Jun 2022 to Jun 2023v24
  4. Re-verified, no change to tracked fieldsv23
  5. Primary completion date: Jun 2019 to Jun 2022 Completion date: Jun 2020 to Jun 2022v22 Show 1 more changeShow less
    • Completion date: Jun 2020 to Jun 2022
  6. Completion date: Jun 2019 to Jun 2020v21
  7. 2 versions Re-verified since May 3, 2018, no change to tracked fieldsv19-v20
  8. Primary completion date: Dec 2017 to Jun 2019 Completion date: Jun 2019 · Interventions: CBASP (Behavioral), Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral) to CBASP (Behavioral), Nicotine Replacement Therapy (Drug), Smoking Cessation Treatment (Behavioral)v18 Show 2 more changesShow less
    • Completion date: Jun 2019
    • Interventions: CBASP (Behavioral), Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral) to CBASP (Behavioral), Nicotine Replacement Therapy (Drug), Smoking Cessation Treatment (Behavioral)
  9. Primary completion date: Dec 2016 to Dec 2017v17
  10. Primary completion date: Dec 2015 to Dec 2016 Study site revisedv16 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv15
  12. Primary completion date: Dec 2014 to Dec 2015v14
  13. Trial status: Recruiting to Active, Not Recruiting Site details revisedv13 Show 1 more changeShow less
    • Site details revised
  14. Re-verified, no change to tracked fieldsv12
  15. Primary completion date: Dec 2012 to Dec 2014v11
  16. Primary completion date: Dec 2011 to Dec 2012v10
  17. Enrollment target: 117 to 202 Primary completion date: Dec 2010 to Dec 2011 · Study description expanded, about 312 wordsv9 Show 2 more changesShow less
    • Primary completion date: Dec 2010 to Dec 2011
    • Study description expanded, about 312 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study site revisedv8 See this version in full on ClinicalTrials.gov ↗
  19. Enrollment target: 91 to 117 Study description shortened, about 1,528 words · Eligibility criteria expanded, about 1 wordv7 Show 2 more changesShow less
    • Study description shortened, about 1,528 words
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  20. Primary completion date: Dec 2009 to Dec 2010 Primary endpoint revised · Eligibility criteria expanded, about 24 words · Secondary endpoints shortened, about 26 wordsv6 Show 3 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints shortened, about 26 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study description expanded, about 116 wordsv5 See this version in full on ClinicalTrials.gov ↗
  22. Primary completion date: Dec 2008 to Dec 2009 Interventions: Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral), Smoking Cessation Treatment + CBASP (Behavioral) to CBASP (Behavioral), Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral) · Secondary endpoints: details revised at 1 of 1 entryv4 Show 2 more changesShow less
    • Interventions: Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral), Smoking Cessation Treatment + CBASP (Behavioral) to CBASP (Behavioral), Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral)
    • Secondary endpoints: details revised at 1 of 1 entry
  23. Primary endpoints: 2 to 1 Primary completion date: Dec 2008 · Completion date: Dec 2008 to not stated · Eligibility criteria expanded, about 17 words · 2 morev3 Show 5 more changesShow less
    • Primary completion date: Dec 2008
    • Completion date: Dec 2008 to not stated
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoint revised
    • Study description expanded, about 192 words

    See this version in full on ClinicalTrials.gov ↗

  24. Completion date: Dec 2008 Interventions: Nicotine Patch (Device), Smoking Cessation (Behavioral) to Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral), Smoking Cessation Treatment + CBASP (Behavioral) · Eligibility criteria revised · Study description shortened, about 64 words · 1 morev2 Show 4 more changesShow less
    • Interventions: Nicotine Patch (Device), Smoking Cessation (Behavioral) to Nicotine Replacement Therapy (Behavioral), Smoking Cessation Treatment (Behavioral), Smoking Cessation Treatment + CBASP (Behavioral)
    • Eligibility criteria revised
    • Study description shortened, about 64 words
    • Study arms: 0 to 2

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Objectives: Primary Aim: To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to: 1\. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence Secondary Aims: 1. To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and; 2. That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment. 3. To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and: 4. To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.
Trial Details
NCT Number NCT00494728
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Institute of Mental Health (NIMH)
Conditions Smoking, Depression
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov