Recruiting

CBI

Sponsor:

VA Office of Research and Development

Code:

NCT06442514

Conditions

Smoking

Pain

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PASS2

Treatment as Usual

Study Details

Brief summary:

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use nightly surveys to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Conditions

Smoking

Pain

Smoking Cessation

Study ID

NCT06442514

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • being an enrolled Veteran at VACHS
  • current tobacco use
  • willingness to make a quit attempt
  • significant chronic pain defined as >/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days

Exclusion Criteria:

  • active diagnosis of dementia or psychosis in medical record
  • severely impaired hearing or speech
  • lack of telephone access
  • enrollment in concurrent research study that might affect main outcomes of this study
  • terminal illness
  • non-English speaking
  • pregnancy
  • provider advising against exercise
  • planned surgeries
  • clinically significant depressive symptoms (>10 PHQ-9)

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PASS2

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly surveys. Veterans in PASS2 will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).

other: Treatment as Usual

Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service

Interventions

PASS2

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly surveys to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.

Treatment as Usual

Referral to the local smoking cessation VA clinic.

Primary outcome measure

  • Cigarette Smoking Abstinence Rates [ Time Frame: 10-month follow-up ]

Central Contacts and Locations

Central contacts

Lori A Bastian, MD MPH

(203) 932-5711Lori.Bastian@va.gov

Mary Driscoll, PhD

(203) 932-5744Mary.Driscoll3@va.gov

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Lori A Bastian, MD MPH

(203) 932-5711Lori.Bastian@va.gov

Principal Investigator:

Lori Anne Bastian, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.