Aversive Therapy for Smoking Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2021-05-01

Brief Summary

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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. Participants will be smokers who are highly motivated to quit. Participants will be randomized into intervention and control groups.

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Detailed Description

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The participants will be evaluated after 1 week and assessed for their ongoing participation and commitment to the study. Those still interested and eligible will be randomized to two groups described below and will continue the study for 3 more weeks. There will be follow up surveys at various time points while wearing the wristband (1 week, 2 week, 3 weeks) and a final survey at T=3 months.

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 wear the device for a total of 4 weeks.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pavlok wristband with electric stimulus

Participants in intervention group will wear wristband and will get a slight electric stimulus when they press the device

Group Type EXPERIMENTAL

Pavlok wristband with electric stimulus

Intervention Type OTHER

it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Device has maximum voltage of 0-500 volts, delivers a electric stimulus for a maximum of 1 sec and average duration of 0.2 secs

Pavlok wristband without electric stimulus

Participants in control group will wear wristband and will not get a slight electric stimulus when they press the device

Group Type PLACEBO_COMPARATOR

Pavlok wristband without electric stimulus

Intervention Type OTHER

it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Participants will not receive any electric stimulus since this feature will be turned off.

Interventions

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Pavlok wristband with electric stimulus

it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Device has maximum voltage of 0-500 volts, delivers a electric stimulus for a maximum of 1 sec and average duration of 0.2 secs

Intervention Type OTHER

Pavlok wristband without electric stimulus

it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Participants will not receive any electric stimulus since this feature will be turned off.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Current smoker (defined by the Center for Disease Control 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 30 days
* Subject is equal to or greater than 19 years old
* Considers themselves "tech savvy" (based on self reported 5 point likert scale)
* Must have a smart phone with blue tooth capabilities
* Willing to receive aversive therapy if assigned to this group.

Exclusion Criteria

* Anyone with a diagnosed arrhythmia or with a pacemaker or with a phobia or history of psychosis.
* Non-English speaking caregivers
* Lives outside of contiguous United States

Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No