Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

Completed · Phase 4 · Has a placebo group

Conditions studied: Nicotine Dependence, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02378714

Run by

Northwestern University

People needed

300

Starts

2015-07-24

Expected to finish

2020-03-13

Last updated by the study team

2021-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
• meet criteria for current or lifetime MDD without psychotic features
• 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
• speak, read, and write fluently in English
• able to provide written informed consent
• intend to reside in the geographic area for >8 months
• 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.
• The candidate had to answer "yes" to the question: "Are you interested in quitting smoking?"

You may not qualify if…

• current enrollment or plan to enroll in another smoking cessation program in the next 8 months
• regular (daily) use of e-cigarettes, chewing tobacco, snuff, snus, or other tobacco products
• current use or plan to use nicotine replacement therapy or other smoking cessation medication within the next 8 months
• medications indicated for bipolar or psychotic disorder if prescribed for bipolar or psychotic disorder
• pregnant or planning to become pregnant within the next 8 months, or breast feeding
• history of seizures or current seizure disorder without medication
• 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
• any prior solid organ transplant or prior hematopoietic stem cell transplant
• alcohol consumption exceeding 28 drinks per week
• cirrhosis or end-stage liver disease
• systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg after two readings or symptomatic uncontrolled stage II hypertension
• unstable cardiovascular disease within 3 months prior to baseline or other cardiovascular disease requiring hospitalization
• prior hospitalization for heart failure
• previous allergic reaction to varenicline
• high suicide risk based on the Columbia Suicide Severity Rating Scale
• lifetime bipolar or psychotic disorder as determined by either self-report or clinical interview

Where it is running

• Northwestern University — Chicago, Illinois, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.