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Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

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ClinicalTrials.gov Identifier: NCT02378714
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brian Hitsman, Northwestern University

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 4, 2015
Last Update Posted Date May 15, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Point-prevalence abstinence [ Time Frame: 27 weeks (24 weeks post target quit date) ]
Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for >7 days prior to week 27 (24 weeks post target quit date) and have an expired carbon monoxide reading of ≤8 parts per million at week 27.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02378714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Prolonged abstinence [ Time Frame: 27 weeks (24 weeks post target quit date) ]
    <7 consecutive days of self-reported smoking after a 2-week grace period
  • Continuous abstinence [ Time Frame: 27 weeks (24 weeks post target quit date) ]
    No smoking between target quit date (week 3) and week 27
  • Time to 7-day relapse [ Time Frame: 27 weeks (24 weeks post target quit date) ]
    Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)
  • Medication adverse events [ Time Frame: 13 weeks (end of 12 weeks of study drug) ]
    Proportion of participants who experience moderate to severe adverse events in the varenicline arm versus the placebo arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Official Title  ICMJE Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Brief Summary Persons who struggle with depression smoke at high rates and experience low quit rates in treatment. The best way to improve cessation treatment for this underserved population remains unknown. The proposed trial tests whether the combination of varenicline and behavioral mood management treatment enhances long-term abstinence for depressed smokers and, if so, whether this treatment achieves its effects through addressing the unique psychological factors that appear to maintain tobacco dependence for these smokers.
Detailed Description Upwards of 43% of persons with major depressive disorder (MDD) are daily smokers who are more likely to smoke heavily, show greater tobacco dependence, suffer more severe withdrawal, and experience lower quit rates than smokers without MDD. Little is known about treatment strategies that might optimize smoking cessation for smokers with MDD because almost all randomized clinical trials have excluded these smokers. This project answers many prominent but largely unanswered calls over the last decade to address tobacco dependence in persons with mental health disorders, especially major depressive disorder (MDD). Using a double-blind, placebo-controlled, randomized design, the investigators will evaluate the efficacy of behavioral activation for smoking cessation (BASC) plus varenicline for treating tobacco dependence in smokers with current or lifetime MDD. Three hundred and thirty daily (≥1 cigarettes/day) smokers will be randomized to receive 12 weeks of one of four treatments: 1) Standard behavioral cessation treatment (ST) + placebo; 2) Behavioral activation integrated with ST (BASC) + placebo; 3) ST + varenicline; or 4) BASC + varenicline. Both BASC and ST will be administered in eight 45 minute sessions, occurring weekly for the first four weeks and biweekly for the final eight weeks. Randomization will be stratified on clinical site (Northwestern, University of Pennsylvania), gender, and severity of depressive symptoms (minimal/mild vs. moderate/severe). The primary outcomes will be carbon monoxide (CO) verified 7-day point prevalence abstinence at 24-weeks post-quit. Additional aims include assessing adverse event rates between varenicline and placebo arms, and testing for mediation of treatment effects by anhedonia, cognitive function (attention and memory), cigarette reward value, and craving and withdrawal. This randomized controlled trial will be the first adequately powered trial of BASC in this population; the first trial to evaluate varenicline among a community sample of smokers with MDD; and the first trial to assess the main and combined effects of these two treatments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nicotine Dependence
  • Major Depressive Disorder
Intervention  ICMJE
  • Drug: Varenicline
    Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
    Other Name: Chantix
  • Behavioral: BASC

    The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.

    Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.

    Other Name: Behavioral activation for smoking cessation
  • Behavioral: Standard treatment
    Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
    Other Name: Standard Therapy
Study Arms  ICMJE
  • Placebo Comparator: Standard treatment + placebo varenicline
    Standard behavioral smoking cessation treatment plus placebo varenicline
    Intervention: Behavioral: Standard treatment
  • Experimental: BASC + placebo varenicline
    Behavioral activation for smoking cessation plus placebo varenicline
    Intervention: Behavioral: BASC
  • Active Comparator: Standard treatment + active varenicline
    Standard behavioral smoking cessation treatment plus active varenicline
    Interventions:
    • Drug: Varenicline
    • Behavioral: Standard treatment
  • Experimental: BASC + active varenicline
    Behavioral activation for smoking cessation plus active varenicline
    Interventions:
    • Drug: Varenicline
    • Behavioral: BASC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
330
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
576
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
  2. meet criteria for current or lifetime MDD without psychotic features
  3. have or are willing to acquire a personal email address and access to a camera phone or other method for submission of therapy practice assignments
  4. speak, read, and write fluently in English
  5. able to provide written informed consent
  6. intend to reside in the geographic area for >8 months
  7. women of childbearing potential must agree to use a medically acceptable method of birth control or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.

Exclusion criteria:

  1. current enrollment or plan to enroll in another smoking cessation program in the next 8 months
  2. regular (daily) use of e-cigarettes, chewing tobacco, snuff, snus, or other tobacco products
  3. current use or plan to use nicotine replacement therapy or other smoking cessation medication within the next 8 months
  4. medications indicated for bipolar or psychotic disorder if prescribed for bipolar or psychotic disorder
  5. pregnant or planning to become pregnant within the next 8 months, or breast feeding
  6. history of seizures or current seizure disorder without medication
  7. history of severe (stage IV or V) chronic kidney disease including current or prior end stage renal disease on either hemodialysis or peritoneal dialysis or prior renal transplant
  8. any prior solid organ transplant or prior hematopoietic stem cell transplant
  9. alcohol consumption exceeding 28 drinks per week
  10. cirrhosis or end-stage liver disease
  11. systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg after two readings or symptomatic uncontrolled stage II hypertension
  12. unstable cardiovascular disease within 3 months prior to baseline or other cardiovascular disease requiring hospitalization
  13. prior hospitalization for heart failure
  14. previous allergic reaction to varenicline
  15. high suicide risk based on the Columbia Suicide Severity Rating Scale
  16. lifetime bipolar or psychotic disorder as determined by either self-report or clinical interview
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Celine M Reyes, M.A. 6309474734 celine.reyes@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02378714
Other Study ID Numbers  ICMJE STU00100303
1R01CA184211-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian Hitsman, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Brian Hitsman, Ph.D. Northwestern University
PRS Account Northwestern University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP