Aversive Therapy for Smoking Cessation

The University of Alabama at Birmingham

Status: Completed

Conditions: Smoking Cessation

Treatments: Other: Pavlok wristband without electric stimulus; Other: Pavlok wristband with electric stimulus

Study type: Interventional

Funder types: Other

Identifiers

NCT03450148

F23234543

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups, including a placebo group

Pavlok wristband with electric stimulus

Experimental group

Description:

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

Treatment:

Other: Pavlok wristband with electric stimulus

Pavlok wristband without electric stimulus

Placebo Comparator group

Description:

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

Treatment:

Other: Pavlok wristband without electric stimulus