DBT for Smoking Cessation in High Risk Veterans

NCT06687577 | Completed DMC

• 1 other identifier: 101760002
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Suicidal; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who stop using tobacco

  Reduction in use or abstinence

  6 months

Secondary Outcomes (3)

• Average change per participant in quality of sleep

  6 months

• Average improvement in physical pain per participant

  6 months

• Average improvement in negative mood per participant

  6 months

Study Arms (2)

DBT

EXPERIMENTAL

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

Behavioral: DBT-C

TAU

ACTIVE COMPARATOR

Standard behavioral cessation intervention.

Behavioral: Treatment as usual

Interventions

DBT-C BEHAVIORAL

Tobacco cessation treatment adapted for high risk population.

DBT

Treatment as usual BEHAVIORAL

Standard behavioral tobacco cessation treatment.

Also known as: TAU

TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran receiving VA healthcare
• multiple indicators of elevated suicide risk in 6 month period

You may not qualify if:

• cognitive impairment
• unable to attend virtual intervention

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• University of California: collaborator

Study Sites (1)

Veterans Medical Research Foundation

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Neal M. Doran

  Veterans Medical Research Foundation / VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to DBT or to treatment as usual (TAU)

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: November 13, 2024
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)