Recruiting

Tobacco Treatment

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06582693

Conditions

Smoking

Smoking Cessation

Second Hand Tobacco Smoke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Refer2Quit

Study Details

Brief summary:

The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group. This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit.

Conditions

Smoking

Smoking Cessation

Second Hand Tobacco Smoke

Study ID

NCT06582693

Start date

Sep 6, 2024

Status verified date

Aug, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Adult Intervention Subject Inclusion Criteria

  • Males or females ages ≥18 years in age
  • Self-identify as a current combustible tobacco user
  • Have a valid cell phone number

Child Intervention Subject Inclusion Criteria

  • Must be a CHOP patient

Adult Intervention Subject Exclusion Criteria

  • <18 years in age.
  • Indicates no combustible tobacco smoking

Child Intervention Subject Exclusion Criteria

  • Not a CHOP patient

Adult Control Subject Inclusion Criteria

  • Males or females ages ≥18 years in age
  • Self-identify as a current combustible tobacco user
  • Have a valid cell phone number

Child Control Subject Inclusion Criteria

  • Must be a CHOP patient

Adult Control Subject Exclusion Criteria

  • <18 years in age.
  • Indicates no combustible tobacco smoking

Child Control Subject Exclusion Criteria

  • Not a CHOP patient

Study Design

Enrollment

3200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Adult intervention arm participants will receive motivational counseling provided by the study staff member enrolling them. The study team member will offer 4 evidence-based treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), emphasizing that the combination is often more effective than one treatment alone, and that they could start treatment even if they are not ready to quit.

no intervention: Control Arm

Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own

Interventions

Refer2Quit

The Refer2Quit intervention consists of automatic connection to the adult participant's choice of any or all of four evidence-based tobacco treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), as well as motivational counseling provided by the study team. Supportive and motivational text messaging is also included in the intervention to connect or reconnect adult participants to treatments as needed. Text messaging and support would also focus on supporting appropriate use of NRT and/or varenicline if indicated.

Primary outcome measure

  • The proportion of adult participants who engage in any evidence-based tobacco use treatments [ Time Frame: Baseline, 1 and 6 months ]
  • Combustible tobacco quit rate at 1 and 6 months [ Time Frame: 1 and 6 months ]

Central Contacts and Locations

Central contacts

Brian P Jenssen, MD, MSHP

267-559-1566jenssenb@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Brian P Jenssen, MD, MSHP

267-559-1566jenssenb@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Smoking
  • Smoking Cessation
  • Second Hand Tobacco Smoke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-08-06.