Back to results

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

Primary Purpose

Nicotine Dependence, Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Varenicline

BASC

Standard treatment

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking Cessation, Major Depressive Disorder, Nicotine Dependence, Varenicline, Behavioral Activation Therapy, Cigarette Smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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?"

Exclusion criteria:

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

Sites / Locations

Northwestern University
University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Active Comparator

Experimental

Arm Label

Standard treatment + placebo varenicline

BASC + placebo varenicline

Standard treatment + active varenicline

BASC + active varenicline

Arm Description

Standard behavioral smoking cessation treatment plus placebo varenicline

Behavioral activation for smoking cessation plus placebo varenicline

Standard behavioral smoking cessation treatment plus active varenicline

Behavioral activation for smoking cessation plus active varenicline

Outcomes

Primary Outcome Measures

Bioverified Point-prevalence Abstinence at 27 Weeks

Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for >7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27.

Adverse Event and Serious Adverse Event Rates

Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019). Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., & Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569.

Secondary Outcome Measures

Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)

Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for >7 days prior to week 14 (11-weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 14.

Prolonged Abstinence

<7 consecutive days of self-reported smoking after a 2-week grace period

Continuous Abstinence

No smoking between target quit date (week 3) and week 27

Time to 7-day Relapse

Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)

Full Information

NCT ID

NCT02378714

First Posted

February 27, 2015

Last Updated

July 27, 2021

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02378714

Brief Title

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

Official Title

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 24, 2015 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence, Major Depressive Disorder

Keywords

Smoking Cessation, Major Depressive Disorder, Nicotine Dependence, Varenicline, Behavioral Activation Therapy, Cigarette Smoking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard treatment + placebo varenicline

Arm Type

Placebo Comparator

Arm Description

Standard behavioral smoking cessation treatment plus placebo varenicline

Arm Title

BASC + placebo varenicline

Arm Type

Experimental

Arm Description

Behavioral activation for smoking cessation plus placebo varenicline

Arm Title

Standard treatment + active varenicline

Arm Type

Active Comparator

Arm Description

Standard behavioral smoking cessation treatment plus active varenicline

Arm Title

BASC + active varenicline

Arm Type

Experimental

Arm Description

Behavioral activation for smoking cessation plus active varenicline

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Chantix

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.

Intervention Type

Behavioral

Intervention Name(s)

BASC

Other Intervention Name(s)

Behavioral activation for smoking cessation

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard treatment

Other Intervention Name(s)

Standard Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Bioverified Point-prevalence Abstinence at 27 Weeks

Description

Time Frame

27 weeks (24-weeks post-target quit date)

Title

Adverse Event and Serious Adverse Event Rates

Description

Time Frame

Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)

Secondary Outcome Measure Information:

Title

Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)

Description

Time Frame

14 weeks (11-weeks post-target quit date)

Title

Prolonged Abstinence

Description

<7 consecutive days of self-reported smoking after a 2-week grace period

Time Frame

27 weeks (24 weeks post target quit date)

Title

Continuous Abstinence

Description

No smoking between target quit date (week 3) and week 27

Time Frame

27 weeks (24 weeks post target quit date)

Title

Time to 7-day Relapse

Description

Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)

Time Frame

27 weeks (24 weeks post target quit date)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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?" Exclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Hitsman, Ph.D.

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24042367

Citation

Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005. Erratum In: Ann Intern Med. 2013 Oct 15;159(8):576.

Results Reference

background

PubMed Identifier

18298238

Citation

Blalock JA, Robinson JD, Wetter DW, Schreindorfer LS, Cinciripini PM. Nicotine withdrawal in smokers with current depressive disorders undergoing intensive smoking cessation treatment. Psychol Addict Behav. 2008 Mar;22(1):122-8. doi: 10.1037/0893-164X.22.1.122.

Results Reference

background

PubMed Identifier

21049087

Citation

Ebbert JO, Wyatt KD, Hays JT, Klee EW, Hurt RD. Varenicline for smoking cessation: efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010 Oct 5;4:355-62. doi: 10.2147/ppa.s10620.

Results Reference

background

PubMed Identifier

22038468

Citation

Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26.

Results Reference

background

PubMed Identifier

19527557

Citation

Hitsman B, Moss TG, Montoya ID, George TP. Treatment of tobacco dependence in mental health and addictive disorders. Can J Psychiatry. 2009 Jun;54(6):368-78. doi: 10.1177/070674370905400604.

Results Reference

background

PubMed Identifier

23072580

Citation

Hitsman B, Papandonatos GD, McChargue DE, DeMott A, Herrera MJ, Spring B, Borrelli B, Niaura R. Past major depression and smoking cessation outcome: a systematic review and meta-analysis update. Addiction. 2013 Feb;108(2):294-306. doi: 10.1111/add.12009.

Results Reference

background

PubMed Identifier

19323966

Citation

Philip NS, Carpenter LL, Tyrka AR, Whiteley LB, Price LH. Varenicline augmentation in depressed smokers: an 8-week, open-label study. J Clin Psychiatry. 2009 Jul;70(7):1026-31. doi: 10.4088/jcp.08m04441. Epub 2009 Mar 24.

Results Reference

background

PubMed Identifier

20099950

Citation

MacPherson L, Tull MT, Matusiewicz AK, Rodman S, Strong DR, Kahler CW, Hopko DR, Zvolensky MJ, Brown RA, Lejuez CW. Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms. J Consult Clin Psychol. 2010 Feb;78(1):55-61. doi: 10.1037/a0017939.

Results Reference

background

Links:

URL

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf

Description

FDA Product Information for Varenicline

Learn more about this trial

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

We'll reach out to this number within 24 hrs