CBASP + Smoking Cessation for Depressed Smokers

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Nicotine replacement

Disqualifiers: Psychotic, Bipolar, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

91 Participants Needed

Trial Summary

What is the purpose of this trial?

Objectives: Primary Aim: To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to: 1. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence Secondary Aims: 1. To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and; 2. That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment. 3. To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and: 4. To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current antidepressants to participate in this trial.

What data supports the effectiveness of the treatment CBASP + Smoking Cessation for Depressed Smokers?

Research shows that combining cognitive-behavioral treatment for depression with smoking cessation strategies can be particularly beneficial for smokers with a history of major depressive disorder, especially those who are heavy smokers. Additionally, nicotine replacement therapies, like patches and gum, have been shown to double the chances of quitting smoking. ^{1 2 3 4 5}

Is the combination of CBASP and smoking cessation treatments like nicotine replacement therapy safe for humans?

Nicotine replacement therapies like patches, gum, and lozenges are generally considered safe and are not contraindicated for people with heart disease. Bupropion, often used in smoking cessation, is generally well tolerated, though there have been rare reports of liver issues. Varenicline, another smoking cessation drug, has raised concerns about psychiatric side effects, but its safety is still being studied. ^{6 7 8 9 10}

How does the CBASP + Smoking Cessation Treatment differ from other treatments for depressed smokers?

The CBASP + Smoking Cessation Treatment is unique because it combines a specialized therapy for depression (CBASP) with smoking cessation strategies, addressing both depression and nicotine dependence simultaneously, which is not typically done in standard treatments that often focus on one condition at a time. ^{3 10 11 12 13}

Research Team

Jan Blalock

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for smokers aged 16 or older who are also dealing with depression, including major depressive disorder (recurrent or single episode lasting over 2 years) or dysthymia. Participants must smoke at least 5 cigarettes daily, score ≥8 on the PHQ depression scale, be willing to quit within six weeks and attend all sessions. Exclusions include current psychotherapy, severe medical conditions, use of nicotine patches if contraindicated, pregnancy/lactation, high suicide risk, psychotic/bipolar disorders.

Inclusion Criteria

I have been diagnosed with a long-term or recurring major depressive disorder.

Exclusion Criteria

Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation

History of psychotic or bipolar disorder

Involvement in any smoking cessation activities

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive counseling sessions and nicotine patches to aid smoking cessation

5 weeks

6 visits (in-person)

Follow-up

Participants are monitored for abstinence, mood, and smoking behavior at 3 and 6 months post-treatment

6 months

2 visits (in-person)

Treatment Details

Interventions

• CBASP
• Nicotine Replacement Therapy
• Smoking Cessation Treatment

Trial Overview The study tests whether a combination of cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment improves quitting success and reduces depressive symptoms compared to Health Education combined with smoking cessation treatment. It will also explore how brain responses to emotional/smoking cues relate to quitting success.

Participant Groups

Group I: ST Experimental Treatment 2 Interventions

Smoking Cessation Treatment (ST)

Group II: CBASP + ST Experimental Treatment 3 Interventions

Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a study involving 179 cigarette smokers with a history of major depressive disorder, both standard smoking cessation treatment and a combined treatment for depression showed high abstinence rates after one year, with 24.7% for standard treatment and 32.5% for the combined treatment.

Smokers with recurrent major depressive disorder and those who smoked heavily (25 or more cigarettes a day) had significantly higher abstinence rates when receiving cognitive-behavioral treatment for depression alongside smoking cessation, indicating that this combined approach may be particularly beneficial for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for depression in smoking cessation. Brown, RA., Kahler, CW., Niaura, R., et al.[2019]

This case report highlights the first fatal instance of hepatotoxicity linked to bupropion, occurring in a 55-year-old man who developed severe liver injury after 6 months of treatment for smoking cessation.

The patient exhibited autoimmune features alongside liver injury, suggesting that bupropion can cause significant liver damage, and physicians should be cautious and consider it as a potential cause in patients with unexplained liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fatal case of bupropion (Zyban) hepatotoxicity with autoimmune features: Case report. Humayun, F., Shehab, TM., Tworek, JA., et al.[2018]

In a study of 222 smokers who did not significantly reduce their smoking with nicotine patches, the combination of varenicline and bupropion led to a higher abstinence rate (39.8%) compared to varenicline plus placebo (25.9%).

The combination treatment was particularly effective for male smokers and those with high nicotine dependence, suggesting it may be a better option for these groups when initial nicotine patch treatment fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Rose, JE., Behm, FM.[2022]

Varenicline is the most effective first-line pharmacotherapy for smoking cessation, showing a significant effect compared to placebo with an odds ratio of 2.27, followed by bupropion (1.69) and nicotine replacement therapy (1.60).

Despite some safety concerns, regulatory agencies deem bupropion and varenicline to have a favorable benefit/risk profile, but healthcare providers should monitor patients for potential neuropsychiatric symptoms, especially in those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. Aubin, HJ., Luquiens, A., Berlin, I.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for depression in smoking cessation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

New developments in smoking cessation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Development of depression during placebo-controlled trials of bupropion for smoking cessation: case reports. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Bupropion and Varenicline for Smokers With Baseline Depressive Symptoms. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The relationship between depression and smoking cessation outcomes in treatment-seeking substance abusers. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A fatal case of bupropion (Zyban) hepatotoxicity with autoimmune features: Case report. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events associated with varenicline: an intensive postmarketing prospective cohort study in New Zealand. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Medications in smoking cessation]. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Smoking cessation: nicotine replacement, gums and patches. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Effect of bupropion on depression symptoms in a smoking cessation clinical trial. [2013]