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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 : September 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brian Hitsman, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Major Depressive Disorder Drug: Varenicline Behavioral: BASC Behavioral: Standard treatment Phase 4

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 recent (past two years) MDD. Five hundred and seventy-six 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Study Start Date : June 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard treatment + placebo varenicline
Standard behavioral smoking cessation treatment plus placebo varenicline
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

Experimental: BASC + placebo varenicline
Behavioral activation for smoking cessation plus placebo varenicline
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

Active Comparator: Standard treatment + active varenicline
Standard behavioral smoking cessation treatment plus active varenicline
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: 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

Experimental: BASC + active varenicline
Behavioral activation for smoking cessation plus active varenicline
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Continuous abstinence [ Time Frame: 27 weeks (24 weeks post target quit date) ]
    No smoking between target quit date (week 3) and week 27

  3. 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)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378714


Contacts
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Contact: Anna Veluz Wilkins, M.A. 312 503-3098 a-veluz-wilkins@northwestern.edu
Contact: Celine Reyes, M.S. 312 503-3035 celine.reyes@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Amanda R Mathew, Ph.D.    312-503-3040    amanda.mathew@northwestern.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Su Fen Lubitz    215-746-4040    lubitz@mail.med.upenn.edu   
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brian Hitsman, Ph.D. Northwestern University

Additional Information:
Publications:

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Responsible Party: Brian Hitsman, Associate Professor of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02378714     History of Changes
Other Study ID Numbers: STU00100303
1R01CA184211-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Brian Hitsman, Northwestern University:
Smoking Cessation
Major Depressive Disorder
Nicotine Dependence
Varenicline
Behavioral Activation Therapy
Cigarette Smoking

Additional relevant MeSH terms:
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Varenicline
Depressive Disorder
Depression
Depressive Disorder, Major
Tobacco Use Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs