Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)

NCT02873754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-07-13

Study results available
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Summary

This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and increase physical activity among low-income persons. The intervention is called Smoking Treatment and Exercise Program for Underserved Populations (STEP UP).

Conditions

  • Smoking

Interventions

BEHAVIORAL

Cognitive Behavioral Counseling

Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.

BEHAVIORAL

Mobile Contingency Management

Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest increased physical activity.

DRUG

Bupropion

All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.

DRUG

Transdermal nicotine patch

Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant

DRUG

Nicotine polacrilex

Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed

DRUG

Nicotine lozenge

Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed

Sponsors & Collaborators

Principal Investigators

  • Paul Dennis, PhD · Study Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02873754 on ClinicalTrials.gov