Aversive Therapy for Smoking Cessation

NCT03450148 | Completed

• 1 other identifier: F23234543
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

aversive therapy

Outcome Measures

Primary Outcomes (7)

• Participants acceptability: short customized survey

  Participants' acceptability/satisfaction will be assessed using a short customized survey. The survey will include 8 questions with options ranging from strongly agree to strongly disagree for five questions and ranging from satisfaction to dissatisfaction for the remainder 3 questions. Each question will be evaluated individually.

  T=0 to 3 months

• Evaluate the dropout among participants

  Number of participants dropped out from time of randomization. Dropout is defined as missing two follow up assessments.

  T=0 to 3 months

• Enrollment percentage of eligible participants

  PI will evaluate the percentage of participants that were enrolled after the 1 week run in period.

  Baseline to T=0

• Percentage of time wristband worn by participants

  PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours.

  T=0 to one week

• Percentage of time wristband worn by participants

  PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours.

  from one week to two weeks

• Percentage of time wristband worn by participants

  PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours.

  from two week to three weeks

• Participants satisfaction: short customized survey

  Participants' acceptability/satisfaction will be assessed using a short customized survey. The survey will be a Likert scale and will include 2 questions with options ranging from satisfied to dissatisfied (with 1 indicating satisfaction and 5 indicating dissatisfaction). One other question is a likert scale with options ranging from 1-3 with 1 indicating the device was very useful and 3 indicating the device was not at all useful. A higher score indicates a worse outcome (less satisfaction with the device). Each question will be evaluated individually.

  T=0 to 3 months

Secondary Outcomes (7)

• Percentage of participants that made a quit attempt

  From T=0 to one week

• Percentage of participants that made a quit attempt

  From T=1 week to 2 weeks

• Percentage of participants that made a quit attempt

  From T= 2 weeks to 3 weeks

• Average Degree of smoking reduction

  From baseline to 3 months

• Percentage of participants who had cessation of smoking.

  T=0 to T= 3 weeks

Study Arms (2)

Pavlok wristband with electric stimulus

EXPERIMENTAL

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

Other: Pavlok wristband with electric stimulus

Pavlok wristband without electric stimulus

PLACEBO COMPARATOR

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

Other: Pavlok wristband without electric stimulus

Interventions

Pavlok wristband with electric stimulus 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 with electric stimulus

Pavlok wristband without electric stimulus 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.

Pavlok wristband without electric stimulus

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Univeristy of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Laura Rochford, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 1, 2018
• Study Start: July 20, 2018
• Primary Completion: November 30, 2020
• Study Completion: May 1, 2021
• Last Updated: July 15, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)