Dialectical Behavior Therapy for Smoking Addiction

Overseen By Neal M. Doran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Veterans Medical Research Foundation

Disqualifiers: Cognitive impairment, Unable to attend virtual

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment DBT-C for smoking addiction?

While there is no direct evidence for DBT-C, studies show that cognitive-behavioral therapy (CBT), which shares similarities with DBT, can help reduce smoking in the short term. Additionally, CBT has been effective in treating other conditions like depression, which can be related to smoking behavior. ^{1 2 3 4 5}

Is Dialectical Behavior Therapy for Smoking Addiction safe for humans?

There is no specific safety data available for Dialectical Behavior Therapy (DBT) for Smoking Addiction, but DBT is generally considered safe for treating various mental health conditions. It is important to consult with healthcare professionals to understand any potential risks or side effects. ^{6 7 8 9 10}

How is Dialectical Behavior Therapy for Smoking Cessation different from other treatments for smoking addiction?

Dialectical Behavior Therapy for Smoking Cessation (DBT-C) is unique because it combines strategies from cognitive-behavioral therapy with mindfulness and emotional regulation techniques, which are not typically included in standard smoking cessation programs. This approach may be particularly beneficial for individuals who struggle with managing emotions and stress, which are common triggers for smoking. ^{1 5 11 12 13}

What is the purpose of this trial?

Individuals prone to suicidality are typically excluded from tobacco cessation interventions even though they are disproportionately likely to smoke, and even though smoking cessation has been linked to improved mood and reduced risk of suicide. This trial enrolls Veteran smokers at high risk for suicide, and assigns them to receive either cessation treatment as usual, or a novel treatment that incorporates standard behavioral cessation treatment with Dialectical Behavior Therapy (DBT), an evidence-based treatment for suicide risk.

Research Team

Neal M Doran, PhD

Principal Investigator

Veterans Medical Research Foundation / VA

Eligibility Criteria

This trial is for Veteran smokers at high risk of suicide. Participants should be current smokers with a history or risk of depression and suicidality, who are typically excluded from other cessation programs.

Inclusion Criteria

Veteran receiving VA healthcare

Multiple indicators of elevated suicide risk in a 6-month period

Exclusion Criteria

Cognitive impairment

I cannot participate in online treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week, manualized DBT-based group intervention for smoking cessation or standard smoking cessation treatment

12 weeks

Weekly group sessions

Follow-up

Participants are monitored for smoking cessation outcomes, emotion regulation, mood, and suicidality

6 months

Assessments at end of treatment and end of follow-up

Treatment Details

Interventions

• DBT-C

Trial Overview The study compares standard smoking cessation treatment to a new approach combining this standard treatment with Dialectical Behavior Therapy (DBT), which helps manage emotions and reduce suicidal behaviors.

Participant Groups

Group I: DBT Experimental Treatment 1 Intervention

Standard behavioral cessation intervention adapted to incorporate DBT skills for emotion regulation.

Group II: TAU Active Control 1 Intervention

Standard behavioral cessation intervention.

DBT-C is already approved in United States for the following indications:

Approved in United States as DBT-C for:

• Smoking cessation in high-risk veterans
• Suicide prevention

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Recruited

5,100+

University of California

Collaborator

Trials

46

Recruited

208,000+

Findings from Research

The cognitive behavioral therapy (CBT) program called Smoke_less significantly helped smokers reduce their smoking by at least 50% compared to a waiting group, both at 1 week and 6 months after the intervention, indicating its short-term efficacy.

While Smoke_less was more effective than brief counseling in the short term, it did not show significant long-term benefits in terms of smoking reduction or abstinence rates, suggesting the need for further research to enhance its effectiveness for sustained smoking reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. Rüther, T., Kiss, A., Eberhardt, K., et al.[2019]

Extended cognitive behavior therapy (CBT) significantly improved smoking abstinence rates at the 20-week follow-up, with 45% of participants achieving abstinence compared to 29% in the control group, indicating its effectiveness in promoting longer-term cessation.

While the difference in abstinence rates at 52 weeks was not significant (31% vs. 27%), the study suggests that CBT may help smokers maintain non-smoking status, especially for those with a history of depression who responded better to less intensive support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended cognitive behavior therapy for cigarette smoking cessation. Killen, JD., Fortmann, SP., Schatzberg, AF., et al.[2022]

A pilot study involving 49 smokers and their nonsmoking partners tested the effectiveness of Behavioral Couples Therapy (BCT) for smoking cessation, but found no significant differences in cessation rates compared to standard smoking treatment (ST) over 6 months.

Both BCT and ST resulted in similar biochemically verified cessation rates (around 40-55%), indicating that BCT may not be an effective intervention for smoking cessation in couples where one partner smokes and the other does not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral couples therapy for smoking cessation: A pilot randomized clinical trial. LaChance, H., Cioe, PA., Tooley, E., et al.[2023]

In a study of 524 smokers, bupropion significantly reduced negative affect and urges to smoke on quit day, suggesting it helps manage emotional challenges during smoking cessation.

Despite not affecting pre-cessation emotional changes, bupropion's ability to lower negative feelings on quit day was linked to a reduced risk of smoking relapse, highlighting its efficacy in supporting individuals trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of bupropion and cognitive-behavioral treatment for depression on positive affect, negative affect, and urges to smoke during cessation treatment. Strong, DR., Kahler, CW., Leventhal, AM., et al.[2022]

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]

Nicotine replacement therapy (NRT) and bupropion are both safe and effective options for helping smokers quit, with benefits seen in both short and long-term cessation rates.

All patients willing to quit smoking, except those with minimal dependence, should be offered NRT or bupropion, especially when combined with counseling, although NRT is not recommended during pregnancy or for patients with certain heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacotherapy of smoking cessation. Peters, MJ., Morgan, LC.[2020]

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]

Despite the availability of effective smoking cessation treatments like nicotine replacement therapy, varenicline, and bupropion, many smokers do not utilize these options, highlighting the need for new therapies.

The review suggests exploring novel strategies such as repetitive transcranial magnetic stimulation (rTMS) and combination therapies, as well as understanding the neurobiology of nicotine addiction, to enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the implications of the biobehavioral basis of nicotine addiction and its impact on the efficacy of treatment. Bozinoff, N., Le Foll, B.[2019]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

Varenicline, a partial agonist for nicotinic receptors, has been shown to be more effective than nicotine replacement therapies and bupropion for smoking cessation, based on Phase III trials.

While varenicline has an excellent safety profile with mild side effects like nausea, new warnings have been added regarding potential risks of agitation, depression, and suicidality, although a direct causal link has not been confirmed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine dependence and smoking cessation. Tan, L., Tang, Q., Hao, W.[2015]

Cognitive behavior therapy (CBT) for smoking cessation shows a nonsignificant trend towards better abstinence rates compared to a health education control group, indicating potential effectiveness.

Despite the trend in favor of CBT, the study found that it did not improve smokers' coping skills for negative emotions, suggesting that further research is needed to understand how CBT works in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive behavior therapy on smokers' compensatory coping skills. Thorndike, FP., Friedman-Wheeler, DG., Haaga, DA.[2018]

Combining bupropion with nicotine therapy (NT) is more effective for helping smokers quit than using either treatment alone, although the initial quit rate remains below 50%.

Higher doses of nicotine therapy can enhance effectiveness, but there is still much to learn about optimal dosing, treatment duration, and strategies for preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving tobacco cessation: current status, current problems, future possibilities. Vaszar, LT., Sarinas, PS., Lillington, GA.[2017]

The Actify! mobile health app, designed for depressed smokers, showed good acceptability with participants logging in an average of 16.6 times and 63% reporting overall satisfaction, indicating its potential as a widely accessible intervention.

Participants experienced a significant reduction in depressive symptoms and a 31% rate of carbon monoxide-verified smoking abstinence at 6 weeks, suggesting that the app may effectively support both mental health and smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial. Heffner, JL., Watson, NL., Serfozo, E., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Extended cognitive behavior therapy for cigarette smoking cessation. [2022]

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

Behavioral couples therapy for smoking cessation: A pilot randomized clinical trial. [2023]

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

Impact of bupropion and cognitive-behavioral treatment for depression on positive affect, negative affect, and urges to smoke during cessation treatment. [2022]

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

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

6. Australia pubmed.ncbi.nlm.nih.gov

The pharmacotherapy of smoking cessation. [2020]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Understanding the implications of the biobehavioral basis of nicotine addiction and its impact on the efficacy of treatment. [2019]

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

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018]

10. China pubmed.ncbi.nlm.nih.gov

Nicotine dependence and smoking cessation. [2015]

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

Effect of cognitive behavior therapy on smokers' compensatory coping skills. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Achieving tobacco cessation: current status, current problems, future possibilities. [2017]

13. Canada pubmed.ncbi.nlm.nih.gov

A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial. [2020]