Nicotine DependencePhase 4NCT02378714
Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
A Phase 4 study testing Varenicline, BASC and Standard treatment in people with Nicotine Dependence and Major Depressive Disorder, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence, Major Depressive Disorder
- What is being tested?
- Varenicline, BASC and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2015to 13 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?"
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence, Major Depressive Disorder
- Being tested
- Varenicline, BASC, Standard treatment
- Keywords
- Smoking Cessation, Major Depressive Disorder, Nicotine Dependence, Varenicline, Behavioral Activation Therapy, Cigarette Smoking
- Medical subject headings
- Tobacco Use Disorder, Depressive Disorder, Major, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
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.
BASCBehavioural
Also called Behavioral activation for smoking cessation
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 treatmentBehavioural
Also called Standard Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + placebo varenicline | Placebo comparator | Standard behavioral smoking cessation treatment plus placebo varenicline Receives: Behavioral: Standard treatment |
| BASC + placebo varenicline | Experimental | Behavioral activation for smoking cessation plus placebo varenicline Receives: Behavioral: BASC |
| Standard treatment + active varenicline | Active comparator | Standard behavioral smoking cessation treatment plus active varenicline Receives: Drug: Varenicline; Behavioral: Standard treatment |
| BASC + active varenicline | Experimental | Behavioral activation for smoking cessation plus active varenicline Receives: Drug: Varenicline; Behavioral: BASC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 27 weeks (24-weeks post-target quit date)
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.
Measured: Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)
Secondary outcomes (4)
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.
Measured: 14 weeks (11-weeks post-target quit date)
Prolonged Abstinence
<7 consecutive days of self-reported smoking after a 2-week grace period
Measured: 27 weeks (24 weeks post target quit date)
Continuous Abstinence
No smoking between target quit date (week 3) and week 27
Measured: 27 weeks (24 weeks post target quit date)
Time to 7-day Relapse
Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)
Measured: 27 weeks (24 weeks post target quit date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start24 Jul 2015
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Brian Hitsman, Northwestern University
- Investigators
- Brian Hitsman, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378714
- Sponsor's protocol ID
- STU00100303
- Other IDs
- 1R01CA184211-01A1
- Status last verified
- May 2021
- First submitted
- 27 Feb 2015
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 24042367Blalock 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.
PubMed 18298238Ebbert 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.
PubMed 21049087Gierisch 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.
PubMed 22038468Hitsman 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.
PubMed 19527557Hitsman 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.
PubMed 23072580Philip 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.
PubMed 19323966MacPherson 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.
PubMed 20099950Gollan JK, Liverant G, Jao NC, Lord KA, Whitton AE, Hogarth L, Fox E, Bauer AM, Quinn MH, Pizzagalli DA, Leone FT, Papandonatos GD, Schnoll RA, Hitsman B. Depression Severity Moderates Reward Learning Among Smokers With Current or Past Major Depressive Disorder in a Smoking Cessation Randomized Clinical Trial. Nicotine Tob Res. 2024 Apr 22;26(5):639-644. doi: 10.1093/ntr/ntad221.
PubMed 37943674Schnoll R, Wileyto EP, Bauer AM, Fox EN, Blumenthal D, Hosie Quinn M, Leone F, Huffman MD, Khan SS, Gollan JK, Papandonatos GD, Hitsman B. Seeing Through the Blind: Belief About Treatment Randomization and Smoking Cessation Outcome Among People With Current or Past Major Depressive Disorder Who Smoke in a Placebo-Controlled Trial of Varenicline. Nicotine Tob Res. 2024 Apr 22;26(5):597-603. doi: 10.1093/ntr/ntad218.
PubMed 37934573Carroll AJ, Huffman MD, Wileyto EP, Khan SS, Fox E, Smith JD, Bauer AM, Leone FT, Schnoll RA, Hitsman B. Change in cardiovascular health among adults with current or past major depressive disorder enrolled in intensive smoking cessation treatment. J Affect Disord. 2023 Jul 15;333:527-534. doi: 10.1016/j.jad.2023.04.089. Epub 2023 Apr 28.
PubMed 37119868Hitsman B, Papandonatos GD, Gollan JK, Huffman MD, Niaura R, Mohr DC, Veluz-Wilkins AK, Lubitz SF, Hole A, Leone FT, Khan SS, Fox EN, Bauer AM, Wileyto EP, Bastian J, Schnoll RA. Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: A 2 x 2 factorial, randomized, placebo-controlled trial. Addiction. 2023 Sep;118(9):1710-1725. doi: 10.1111/add.16209. Epub 2023 May 3.
PubMed 37069490
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
- ClinicalTrials.gov ID
- NCT02378714
- Acronym / sponsor ID
- STU00100303
- Conditions
- Nicotine Dependence, Major Depressive Disorder
- Keywords
- Smoking Cessation, Major Depressive Disorder, Nicotine Dependence, Varenicline, Behavioral Activation Therapy, Cigarette Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2015 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + placebo varenicline | Placebo comparator | Behavioral: Standard treatmentStandard behavioral smoking cessation treatment plus placebo varenicline |
| BASC + placebo varenicline | Experimental | Behavioral: BASCBehavioral activation for smoking cessation plus placebo varenicline |
| Standard treatment + active varenicline | Active comparator | Drug: Varenicline, Behavioral: Standard treatmentStandard behavioral smoking cessation treatment plus active varenicline |
| BASC + active varenicline | Experimental | Drug: Varenicline, Behavioral: BASCBehavioral activation for smoking cessation plus active varenicline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChantixParticipants 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. | Drug | BASC + active varenicline, Standard treatment + active varenicline |
| BASCAlso: Behavioral activation for smoking cessationThe 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. | Behavioural | BASC + active varenicline, BASC + placebo varenicline |
| Standard treatmentAlso: Standard TherapyStandard 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. | Behavioural | Standard treatment + active varenicline, Standard treatment + placebo varenicline |
Primary outcome
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.
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.
4 secondary outcomes
Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)
Time frame: 14 weeks (11-weeks post-target quit date)
Prolonged Abstinence
Time frame: 27 weeks (24 weeks post target quit date)
Continuous Abstinence
Time frame: 27 weeks (24 weeks post target quit date)
Time to 7-day Relapse
Time frame: 27 weeks (24 weeks post target quit date)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24042367Anthenelli 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.
- Background: PubMed 18298238Blalock 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.
- Background: PubMed 21049087Ebbert 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.
- Background: PubMed 22038468Gierisch 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.
- Background: PubMed 19527557Hitsman 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.
- Background: PubMed 23072580Hitsman 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.
- Background: PubMed 19323966Philip 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.
- Background: PubMed 20099950MacPherson 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.
- Derived from this study: PubMed 37943674Gollan JK, Liverant G, Jao NC, Lord KA, Whitton AE, Hogarth L, Fox E, Bauer AM, Quinn MH, Pizzagalli DA, Leone FT, Papandonatos GD, Schnoll RA, Hitsman B. Depression Severity Moderates Reward Learning Among Smokers With Current or Past Major Depressive Disorder in a Smoking Cessation Randomized Clinical Trial. Nicotine Tob Res. 2024 Apr 22;26(5):639-644. doi: 10.1093/ntr/ntad221.
- Derived from this study: PubMed 37934573Schnoll R, Wileyto EP, Bauer AM, Fox EN, Blumenthal D, Hosie Quinn M, Leone F, Huffman MD, Khan SS, Gollan JK, Papandonatos GD, Hitsman B. Seeing Through the Blind: Belief About Treatment Randomization and Smoking Cessation Outcome Among People With Current or Past Major Depressive Disorder Who Smoke in a Placebo-Controlled Trial of Varenicline. Nicotine Tob Res. 2024 Apr 22;26(5):597-603. doi: 10.1093/ntr/ntad218.
- Derived from this study: PubMed 37119868Carroll AJ, Huffman MD, Wileyto EP, Khan SS, Fox E, Smith JD, Bauer AM, Leone FT, Schnoll RA, Hitsman B. Change in cardiovascular health among adults with current or past major depressive disorder enrolled in intensive smoking cessation treatment. J Affect Disord. 2023 Jul 15;333:527-534. doi: 10.1016/j.jad.2023.04.089. Epub 2023 Apr 28.
- Derived from this study: PubMed 37069490Hitsman B, Papandonatos GD, Gollan JK, Huffman MD, Niaura R, Mohr DC, Veluz-Wilkins AK, Lubitz SF, Hole A, Leone FT, Khan SS, Fox EN, Bauer AM, Wileyto EP, Bastian J, Schnoll RA. Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: A 2 x 2 factorial, randomized, placebo-controlled trial. Addiction. 2023 Sep;118(9):1710-1725. doi: 10.1111/add.16209. Epub 2023 May 3.
- FDA Product Information for VareniclineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Hitsman, Ph.D. principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline, BASC and Standard treatment in people with Nicotine Dependence and Major Depressive Disorder, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioverified Point-prevalence Abstinence at 27 Weeks (time frame: 27 weeks (24-weeks post-target quit date)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02378714, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.