Tobacco DependenceNCT06687577
DBT for Smoking Cessation in High Risk Veterans
A study testing DBT-C and Treatment as usual in people with Tobacco Dependence and Suicidal, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, Suicidal
- What is being tested?
- DBT-C and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran receiving VA healthcare
- multiple indicators of elevated suicide risk in 6 month period
Who cannot join
- cognitive impairment
- unable to attend virtual intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Medical Research Foundation
San Diego, California, 92161
About this study
Official title: Dialectical Behavior Therapy for Smoking Cessation in High Risk Veterans
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.
Read the detailed description
Individuals with behavioral health problems are a significant tobacco-related health disparity group in that they are more likely to use tobacco and evidence disproportionate consequences from their use. Cigarette smoking or usage of other nicotine products is strongly associated with symptoms of emotional distress, while cessation is associated with significant reductions in symptoms of anxiety and depression and improved mental health functioning. Individuals with who have difficulty managing negative emotions (emotional dysregulation) may be especially vulnerable to tobacco dependence and have particular difficulties with smoking cessation. Because cessation studies commonly exclude smokers exhibiting emotional dysregulation (such as recent suicidality and/or acute emotional instability), little extant evidence is available to inform optimal treatment approaches for these smokers.
Dialectical behavior therapy skills group (DBT-SG) is an evidence-based approach to addressing dysregulation of emotion, teaching skills to help manage emotions more effectively. Preliminary empirical work suggests DBT may also be an effective approach to addressing smoking cessation. Difficulty managing negative emotions is a common reason for smoking cessation failure, suggesting that group DBT may be an effective intervention for cessation. Investigators propose to conduct a pilot treatment study with veterans at risk for suicide as an initial step to developing and evaluating the utility of DBT for smoking cessation in subgroups with high levels of emotion dysregulation.
The primary aims of the proposed study are to 1) adapt a 12-week, manualized DBT-based group intervention for smoking cessation (DBT-C); 2) conduct a randomized trial testing whether DBT-C has better smoking cessation outcomes than standard smoking cessation treatment (SCCT); 3) evaluate whether DBT-C participants have greater improvements on measures of emotion regulation, mood and suicidality than those in the SSCT conditions; and 4) examine intervention acceptability and feasibility.
- Conditions
- Tobacco Dependence, Suicidal
- Being tested
- DBT-C, Treatment as usual
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-CBehavioural
Tobacco cessation treatment adapted for high risk population.
Treatment as usualBehavioural
Also called TAU
Standard behavioral tobacco cessation treatment.
| Study group | Role | What they receive |
|---|---|---|
| DBT | Experimental | Standard behavioral cessation intervention adapted to incorporate DBT skills for emotion regulation. Receives: Behavioral: DBT-C |
| TAU | Active comparator | Standard behavioral cessation intervention. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who stop using tobacco
Reduction in use or abstinence
Measured: 6 months
Secondary outcomes (3)
Average change per participant in quality of sleep
Change in sleep quality/quantity will be evaluated using the Insomnia Severity Index (ISI), a brief, valid measure of sleep quality. The ISI will be administered at baseline, end of treatment, and end of follow-up.
Morin et al. (2011). The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 34(5), 601-8.
Measured: 6 months
Average improvement in physical pain per participant
Participants will self-report frequency of pain on scale from 0 (rarely/never) to 7 (always/almost always). They will self-report pain intensity on a similar scale from 0 (no/mild pain) to 7 (severe pain). These measures are completed at baseline, end of treatment, and end of follow-up.
Measured: 6 months
Average improvement in negative mood per participant
Change in negative mood will be evaluated via the Positive and Negative Affect Schedule (PANAS), administered at each assessment point. The PANAS asks respondents to indicate the extent to which a series of 10 positive and 10 negative affect terms have applied to them over the past 2 weeks.
Watson et al (1988). Development and validation of brief measures of positive and negative affect: The PANAS scales. J Pers Soc Psychol, 54(6), 1063.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 May 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to DBT or to treatment as usual (TAU)
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of California
- Responsible party
- Sponsor
- Investigators
- Neal M. Doran, Principal investigator, Veterans Medical Research Foundation / VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687577
- Sponsor's protocol ID
- 101760002
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data may be made available upon request from the PI if approved by the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Smoking Cessation in High Risk Veterans
- ClinicalTrials.gov ID
- NCT06687577
- Acronym / sponsor ID
- 101760002
- Conditions
- Tobacco Dependence, Suicidal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- University of California
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with behavioral health problems are a significant tobacco-related health disparity group in that they are more likely to use tobacco and evidence disproportionate consequences from their use. Cigarette smoking or usage of other nicotine products is strongly associated with symptoms of emotional distress, while cessation is associated with significant reductions in symptoms of anxiety and depression and improved mental health functioning. Individuals with who have difficulty managing negative emotions (emotional dysregulation) may be especially vulnerable to tobacco dependence and have particular difficulties with smoking cessation. Because cessation studies commonly exclude smokers exhibiting emotional dysregulation (such as recent suicidality and/or acute emotional instability), little extant evidence is available to inform optimal treatment approaches for these smokers.
Dialectical behavior therapy skills group (DBT-SG) is an evidence-based approach to addressing dysregulation of emotion, teaching skills to help manage emotions more effectively. Preliminary empirical work suggests DBT may also be an effective approach to addressing smoking cessation. Difficulty managing negative emotions is a common reason for smoking cessation failure, suggesting that group DBT may be an effective intervention for cessation. Investigators propose to conduct a pilot treatment study with veterans at risk for suicide as an initial step to developing and evaluating the utility of DBT for smoking cessation in subgroups with high levels of emotion dysregulation.
The primary aims of the proposed study are to 1) adapt a 12-week, manualized DBT-based group intervention for smoking cessation (DBT-C); 2) conduct a randomized trial testing whether DBT-C has better smoking cessation outcomes than standard smoking cessation treatment (SCCT); 3) evaluate whether DBT-C participants have greater improvements on measures of emotion regulation, mood and suicidality than those in the SSCT conditions; and 4) examine intervention acceptability and feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to DBT or to treatment as usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| DBT | Experimental | Behavioral: DBT-CStandard behavioral cessation intervention adapted to incorporate DBT skills for emotion regulation. |
| TAU | Active comparator | Behavioral: Treatment as usualStandard behavioral cessation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veteran receiving VA healthcare
- multiple indicators of elevated suicide risk in 6 month period
Key exclusion criteria (2 listed)
- cognitive impairment
- unable to attend virtual intervention
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 |
|---|---|---|
| DBT-CTobacco cessation treatment adapted for high risk population. | Behavioural | DBT |
| Treatment as usualAlso: TAUStandard behavioral tobacco cessation treatment. | Behavioural | TAU |
Primary outcome
Proportion of participants who stop using tobacco
Time frame: 6 months
Reduction in use or abstinence
3 secondary outcomes
Average change per participant in quality of sleep
Time frame: 6 months
Average improvement in physical pain per participant
Time frame: 6 months
Average improvement in negative mood per participant
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No. Anonymized data may be made available upon request from the PI if approved 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.
Neal M. Doran principal investigator
Veterans Medical Research Foundation / VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-C and Treatment as usual in people with Tobacco Dependence and Suicidal, run by Veterans Medical Research Foundation at 1 site 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 2 inclusion and 2 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants who stop using tobacco (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.