Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

• Status: Completed
• Trial end date: 2020-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Varenicline

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