Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Condition: Nicotine Dependence; Major Depressive Disorder
MeSH terms: Tobacco Use Disorder; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Varenicline; BASC; Standard treatment
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Major Depressive Disorder; Nicotine Dependence; Varenicline; Behavioral Activation Therapy; Cigarette Smoking

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.
    

Eligibility 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.

          8. The candidate had to answer "yes" to the question: "Are you interested in quitting
             smoking?"

        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