Incentives to Promote Smoking Cessation in Low SES Women

NCT03173274 | Terminated

• 1 other identifier: 5-24001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the feasibility of a mobile-phone based contingency management (CM) intervention for smoking in low-SES women. The CM intervention will be combined with a Brief Motivational Interviewing (BMI) counseling component. This study will examine the following research aims: Primary Aim: To compare the effects of a Brief Motivational Intervention (BMI) + mobile phone-based CM on tobacco use when compared to BMI with a non-contingent control condition in a small feasibility trial. Hypothesis: The investigators expect women in the BMI + CM condition to have more smoke free days than women in the BMI + NC condition. Secondary Aim: To examine alcohol use as a moderator of cessation outcomes.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Percent of negative CO samples

  The amount of negative, decreased CO samples submitted by participants

  End of two-week intervention

Study Arms (2)

Contingency Management (CM)

EXPERIMENTAL

Those in the CM condition will continue to provide CO values twice-daily, and will receive escalating reinforcement values for CO values indicating continuous smoking abstinence (CO \< 6 ppm).

Behavioral: Brief Motivational Intervention; Behavioral: Contingency Management

Non-Contingent Reinforcement

ACTIVE COMPARATOR

Participants in the NC condition will also provide CO levels twice-daily. However, their reinforcement will not be contingent upon their CO level but will be yoked to someone in the CM condition so that average reinforcer values are equivalent across the 2 conditions.

Behavioral: Brief Motivational Intervention; Behavioral: Non-Contingent Reinforcement

Interventions

Brief Motivational Intervention BEHAVIORAL

Participants in both groups will be given an BMI intervention in which they will be counseled to quit smoking.

Contingency Management (CM); Non-Contingent Reinforcement

Contingency Management BEHAVIORAL

Contingent Reinforcement for negative breath CO samples

Contingency Management (CM)

Non-Contingent Reinforcement BEHAVIORAL

Participants will receive reinforcement for submitting samples ona yoked schedule unrelated to CO sample value \[CM control\]

Non-Contingent Reinforcement

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Smoke an average of at least ten cigarettes per day for at least 1 year
• Breath CO levels \> 8 ppm
• \>12 years of education
• Reliable and consistent access to a smart phone with video messaging capabilities

You may not qualify if:

• Intention to quit smoking in the next 30 days
• Currently seeking treatment for smoking cessation.
• Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
• No reliable access to a video-messaging smart phone
• Pregnancy

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 1, 2017
• Study Start: February 8, 2018
• Primary Completion: March 3, 2018
• Study Completion: March 3, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)