Clinical trial NCT05154669: Integrating Financial Coaching and Smoking Cessation Coaching
Official title: Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Smoking
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-13
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study conduct a two-arm, parallel-group randomized controlled trial. The study will recruit and randomize 900 smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling.

Detailed description: The study is a two-arm, parallel-group RCT. The study will recruit and randomize 900 low-income smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling. Both groups will receive 8 weeks of nicotine replacement therapy. The study will survey participants at baseline, 6 months, and 12 months to assess outcomes and mechanisms, and biochemically verify self-reported abstinence at 12 months (our primary outcome). The study will assess and compare the costs and cost-per-quit in the two treatment arms.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years,
* smokes ≥5 cigarettes per day,
* interested in receiving smoking and financial counseling,
* self-reported income below 200% of the current federal poverty level,
* New York City resident,
* speaks English or Spanish language (the interventions and measures have not been validated in other languages),
* able to provide informed consent, and
* does not have a representative who manages his/her funds.

Exclusion Criteria

* people who know a current past study participant (to avoid intervention contamination)
* People who have a medical contraindication to using nicotine replacement therapy:
* allergy to nicotine patch
* pregnancy or intention to become pregnant over the next 12 months
* breastfeeding
* heart attack in the past 2 months
* underlying arrhythmia
* ongoing or worsening angina.

Primary outcomes:
measure: Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine)
timeFrame: 12 months
measure: Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration)
timeFrame: 12 months
Secondary outcomes:
measure: Change in quit attempts
timeFrame: 6 and 12 months
measure: Change in self-reported abstinence from cigarettes
timeFrame: 6 and 12 months
measure: Change in self-reported use of electronic nicotine delivery systems use
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Erin Rogers, DrPH
role: PRINCIPAL_INVESTIGATOR
References: