Smoking Cessation in Caregivers of Pediatric Patients With Respiratory Illness



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:19 - 99
Updated:8/9/2018
Start Date:July 20, 2018
End Date:May 1, 2021
Contact:Nipam Shah
Email:nshah@peds.uab.edu
Phone:205-638-7431

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The Acceptability and Feasibility of Self-administered Aversive Therapy for Smoking Cessation in Caregivers of Pediatric Patients With Respiratory Illness

The purpose of this research study is to test a new way to help people quit smoking. The PI
will test acceptability and feasibility of a new device called Pavlok wearable wrist band to
help caregivers of pediatric patients with respiratory illness quit smoking. Participants
will be caregiver of a child with respiratory illness and referred for Nicotine replacement
therapy. Participants will be randomized into intervention and control groups.

The intervention group will continue to wear the wristband and the wristband will deliver a
slight electric stimulus every time it is pressed.

The placebo group will wear continue to press the button on the wristband but it will not
give a slight electric stimulus when pressed. Both groups will receive the device for 3
months only.

Both groups will be evaluated after 1 week and assessed for their participation and
commitment to the study. Those included will be randomized to two groups described above and
will continue the study for 3 months. There will be follow up surveys at various time points
(1 week, 2 week, 3 week, 2 months, 3 month) with the final survey at 3 months. A short follow
up survey will be done at 6 months.

Inclusion Criteria:

- Current smoker (defined by the CDC as an "adult who has smoked 100 cigarettes in his
or her lifetime and who currently smokes cigarettes ". This will be determined based
on participant baseline survey.

- Interested in quitting (contemplation stage and beyond, as defined by serious
consideration of quitting smoking in the next 6 months

- Self-reported caregiver of a patient with respiratory illness

- Subject has been referred to the smoking cessation pharmacy clinic.

- Subject is equal to or greater than19 years old

- Must have a smart phone with blue tooth capabilities

- Willing to receive aversive therapy if assigned to this group.

Exclusion Criteria:

- Anyone already taking varenicline, nicotine replacement (including nicotine patch or
gum, but not including smokeless tobacco), bupropion or any other form of prescription
cessation therapy prior to the enrollment/recruitment.

- Anyone with a diagnosed arrhythmia or with a pacemaker or with a phobia or history of
psychosis.

- Non-English speaking caregivers
We found this trial at
1
site
Birmingham, Alabama 35294
Principal Investigator: Laura Rochford, MD
Phone: 205-638-7431
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mi
from
Birmingham, AL
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