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Completed

NCT Number: NCT03450148

Aversive Therapy for Smoking Cessation

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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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Participants acceptability: short customized survey

    Time frame: T=0 to 3 months

    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.

  2. Evaluate the dropout among participants

    Time frame: T=0 to 3 months

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

  3. Enrollment percentage of eligible participants

    Time frame: Baseline to T=0

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

  4. Percentage of time wristband worn by participants

    Time frame: T=0 to one week

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

  5. Percentage of time wristband worn by participants

    Time frame: from one week to two weeks

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

  6. Percentage of time wristband worn by participants

    Time frame: from two week to three weeks

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

  7. Participants satisfaction: short customized survey

    Time frame: T=0 to 3 months

    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.

Secondary outcomes

  1. Percentage of participants that made a quit attempt

    Time frame: From T=0 to one week

    PI will evaluate the percentage of participants that made a quit attempt as defined by absence of smoking for more than 24 hours in the previous seven days. This will be assessed through the follow up survey given at various intervals.

  2. Percentage of participants that made a quit attempt

    Time frame: From T=1 week to 2 weeks

    PI will evaluate the percentage of participants that made a quit attempt as defined by absence of smoking for more than 24 hours in the previous seven days. This will be assessed through the follow up survey given at various intervals.

  3. Percentage of participants that made a quit attempt

    Time frame: From T= 2 weeks to 3 weeks

    PI will evaluate the percentage of participants that made a quit attempt as defined by absence of smoking for more than 24 hours in the previous seven days. This will be assessed through the follow up survey given at various intervals.

  4. Average Degree of smoking reduction

    Time frame: From baseline to 3 months

    PI will evaluate the average percentage of smoking reduction. This will be quantified by the average number of cigarettes smoked at baseline compared to the average number of cigarettes smoked at 3 months. This will be assessed via the "Follow survey".

  5. Percentage of participants who had cessation of smoking.

    Time frame: T=0 to T= 3 weeks

    P will evaluate the percentage of participants who had cessation of smoking, as defined by the absence of smoking in the previous 30 days. This will be evaluated by the "Three month Questionnaire"

  6. Before and after smoking self-efficacy score

    Time frame: Baseline to 3 months

    The PI will evaluate the self-efficacy of the participant as evaluated by the "Baseline Smoking self-efficacy scale Short form". There are 9 questions which will assess the confidence of the participant to not smoke.The investigators will use Likert scale for each question which assesses the participants confidence to "not smoke" in various circumstances. The answers range from 1 to 5 with 1 indicating "not at all confident" and 5 indicating "extremely confident". The overall score for each participant will be calculated by sum of scores from all items. This score for individual subscales will be calculated by sum item scores so that the total score will range from 9 to 45, with a lower score indicating a worse outcome i.e. less confidence to not smoke).

  7. Stage of change

    Time frame: From baseline until 3 months

    The investigators will use Likert scale for each question to evaluate the motivation to change. A score of 1 indicates that the participant has no intention to quit smoking and the score of 5 indicates that the participant is highly motivated. Evaluate the initial stage of change of the participant as judged by "Screening Questionnaire, Stage of Change". There is only 1 question.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Acceptability and Feasibility of Self Administered Aversive Therapy for Smoking Cessation

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 1, 2018
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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