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Clinical trial

Financial Incentives for Smoking Cessation Among Disadvantaged Mothers With Young Children

ID
Name
5R01HD078332
Description
Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.
Trial arms
Trial start
2015-06-01
Estimated PCD
2019-12-01
Trial end
2020-10-01
Status
Completed
Treatment
Best Practices
Five As plus referral to a quit line
Arms:
Best practices, Best practices and financial incentives, Best practices, financial incentives, and NRT
Other names:
Usual Care
Financial Incentives
Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Arms:
Best practices and financial incentives, Best practices, financial incentives, and NRT
Other names:
Contingency Management
Nicotine Replacement Therapy
Nicotine patches and gum/lozenge provided together for dual therapy
Arms:
Best practices, financial incentives, and NRT
Other names:
NRT
Size
198
Primary endpoint
7-day Point Prevalence Smoking Abstinence Levels
Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms
Objective Measure of Child Secondhand Smoke Exposure (SHSe)
Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date
Eligibility criteria
Inclusion Criteria: * Expresses interest in quitting smoking * Express willingness to initiate NRT * Mother is ≥ 18 years of age * Self-reported smoking ≥ 10 cigarettes per day for ≥ 1 year, biochemically verified * Mother has a child \< 12 years of age * Child resides with mother full-time * Not currently using any other tobacco cessation medications (e.g. Chantix) or NRT, or willing to stop use prior to participation in the study * Lives in Chittenden County, Vermont or surrounding counties * Plans on remaining in the geographical area for the next 12 months * English-speaking * Willing to let child participate in the study Exclusion Criteria: * Failing to meet any of the above criteria * Has medical contraindications to NRT products * Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for moderate or severe alcohol or drug dependence other than nicotine in the prior 12 months (those on opioid substitution therapy are allowed) * Current/past psychotic disorder * Being suicidal * Currently pregnant or trying to become pregnant in the next 12 months * Incarceration * Refusal to participate in study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 198, 'type': 'ACTUAL'}}
Updated at
2023-07-28

1 organization

1 product

1 indication

Organization
University of Vermont
Product
Nicotine Replacement Therapy
Indication
Smoking