- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378714
Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard treatment + placebo varenicline
Standard behavioral smoking cessation treatment plus placebo varenicline
|
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 Names:
|
Experimental: BASC + placebo varenicline
Behavioral activation for smoking cessation plus placebo varenicline
|
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 Names:
|
Active Comparator: Standard treatment + active varenicline
Standard behavioral smoking cessation treatment plus active varenicline
|
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 Names:
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 Names:
|
Experimental: BASC + active varenicline
Behavioral activation for smoking cessation plus active varenicline
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioverified Point-prevalence Abstinence at 27 Weeks
Time Frame: 27 weeks (24-weeks post-target quit date)
|
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.
|
27 weeks (24-weeks post-target quit date)
|
Adverse Event and Serious Adverse Event Rates
Time Frame: Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)
|
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. |
Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)
Time Frame: 14 weeks (11-weeks post-target quit date)
|
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.
|
14 weeks (11-weeks post-target quit date)
|
Prolonged Abstinence
Time Frame: 27 weeks (24 weeks post target quit date)
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<7 consecutive days of self-reported smoking after a 2-week grace period
|
27 weeks (24 weeks post target quit date)
|
Continuous Abstinence
Time Frame: 27 weeks (24 weeks post target quit date)
|
No smoking between target quit date (week 3) and week 27
|
27 weeks (24 weeks post target quit date)
|
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)
|
27 weeks (24 weeks post target quit date)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian Hitsman, Ph.D., Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Tobacco Use Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Nicotinic Agonists
- Cholinergic Agonists
- Varenicline
Other Study ID Numbers
- STU00100303
- 1R01CA184211-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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