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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans at high risk for suicide quit smoking. It tests two methods: the usual approach and a new one that includes Dialectical Behavior Therapy for Smoking Cessation (DBT-C), which aids in emotion management and has been effective in reducing suicide risk. The goal is to determine if combining DBT-C with smoking cessation support can enhance mood and lower suicide risk. Veterans receiving healthcare from the VA and exhibiting several signs of high suicide risk in the past six months may be suitable for this trial. As an unphased trial, it offers Veterans a unique opportunity to explore innovative treatments that could significantly enhance their well-being.

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 prior data suggests that Dialectical Behavior Therapy for Smoking Cessation is safe for individuals at high risk for suicide?

Research has shown that Dialectical Behavior Therapy (DBT) is generally safe for treating various mental health issues, including reducing the risk of suicide. Although specific research on using DBT for quitting smoking is not yet available, it is known to be safe for helping with emotional control and risky behaviors. For quitting smoking, DBT aims to help manage the negative feelings that often lead to smoking, suggesting it could be a helpful and safe method.

This trial examines the use of DBT to help veterans quit smoking, particularly those at high risk for suicide. It combines regular methods for quitting smoking with DBT skills. The safety of DBT in other areas suggests it might be safe here too. However, monitoring individual responses when trying something new remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dialectical Behavior Therapy for smoking addiction is unique because it incorporates DBT skills specifically aimed at emotion regulation. Most treatments for smoking addiction focus solely on behavioral cessation techniques, but this approach adds a layer by addressing the emotional triggers that often lead to smoking. Researchers are excited about DBT-C because it has the potential to offer more comprehensive support for individuals trying to quit, by not only helping them kick the habit but also equipping them with skills to manage their emotions and reduce the likelihood of relapse.

What evidence suggests that DBT-C might be an effective treatment for smoking addiction?

Research has shown that Dialectical Behavior Therapy (DBT) can help people quit smoking, particularly those experiencing negative emotions. In this trial, participants will join one of two groups: one receiving DBT-C, which integrates DBT skills for emotion regulation into a standard behavioral cessation intervention, and another receiving treatment as usual (TAU), a standard behavioral cessation intervention. Early studies suggest that DBT may assist in smoking cessation by addressing emotional triggers. Evidence indicates that combining therapies like DBT with standard methods can improve success rates. Therefore, DBT-C could be a promising option for smokers at high risk for suicide, offering support for both quitting smoking and managing emotional challenges. ^{1 2 4 6 7}

Who Is on the Research Team?

Neal M Doran, PhD

Principal Investigator

Veterans Medical Research Foundation / VA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-tobacco-dependence-4-2023-70e3e

Dialectical Behavior Therapy for Smoking Addiction A pilot study involving 49 smokers and their nonsmoking partners tested the effectiveness of Behavioral Couples Therapy (BCT) for smoking cessation, but found ...

2. trialx.com trialx.com/clinical-trials/listings/324166/dbt-for-smoking-cessation-in-high-risk-veterans/?&radius=50

DBT for Smoking Cessation in High Risk Veterans Preliminary empirical work suggests DBT may also be an effective approach to addressing smoking cessation. Difficulty managing negative emotions ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555596/

Interventions for Smoking Cessation and Treatments ... - NCBI Evidence indicates that the combined use of both behavioral interventions and pharmacotherapies produces the largest cessation effects (Fiore et al. 2008; Stead ...

4. medrxiv.org medrxiv.org/content/10.1101/2024.10.13.24315419v1.full.pdf

Dialectical Behavior Therapy Skills Training as a Brief ... We conclude from this review that DBT-ST holds promise as an adapted intervention for cigarette smoking by patients diagnosed with cancer.

5. tandfonline.com tandfonline.com/doi/abs/10.1080/15504263.2018.1548719

Field Test of a Dialectical Behavior Therapy Skills Training ... The objective of this study was to field test a DBT skills training–based intervention for tobacco dependence and opioid relapse prevention (DBT-Quit) among ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06687577

DBT for Smoking Cessation in High Risk Veterans Preliminary empirical work suggests DBT may also be an effective approach to addressing smoking cessation.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30646819/

Field Test of a Dialectical Behavior Therapy Skills Training ... The objective of this study was to field test a DBT skills training-based intervention for tobacco dependence and opioid relapse prevention (DBT-Quit) among ...