Smoking CessationNCT03450148
Aversive Therapy for Smoking Cessation
A study testing Pavlok wristband with electric stimulus and Pavlok wristband without electric stimulus in people with Smoking Cessation, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Pavlok wristband with electric stimulus and Pavlok wristband without electric stimulus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Acceptability and Feasibility of Self Administered 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.
Read the detailed 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.
- Conditions
- Smoking Cessation
- Being tested
- Pavlok wristband with electric stimulus, Pavlok wristband without electric stimulus
- Keywords
- aversive therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pavlok wristband with electric stimulusOther
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 stimulusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Pavlok wristband without electric stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T=0 to 3 months
Secondary outcomes (7)
Percentage of participants that made a quit attempt
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.
Measured: From T=0 to one week
Percentage of participants that made a quit attempt
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.
Measured: From T=1 week to 2 weeks
Percentage of participants that made a quit attempt
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.
Measured: From T= 2 weeks to 3 weeks
Average Degree of smoking reduction
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".
Measured: From baseline to 3 months
Percentage of participants who had cessation of smoking.
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"
Measured: T=0 to T= 3 weeks
Before and after smoking self-efficacy score
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).
Measured: Baseline to 3 months
Stage of change
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.
Measured: From baseline until 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start20 Jul 2018
- Primary completion30 Nov 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nipam Shah, MD, University of Alabama at Birmingham
- Investigators
- Laura Rochford, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450148
- Sponsor's protocol ID
- F23234543
- Status last verified
- Sep 2020
- First submitted
- 13 Feb 2018
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Self Administered Aversive Therapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03450148
- Acronym / sponsor ID
- F23234543
- Conditions
- Smoking Cessation
- Keywords
- aversive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pavlok wristband with electric stimulus | Experimental | Other: Pavlok wristband with electric stimulusParticipants in intervention group will wear wristband and will get a slight electric stimulus when they press the device |
| Pavlok wristband without electric stimulus | Placebo comparator | Other: Pavlok wristband without electric stimulusParticipants in control group will wear wristband and will not get a slight electric stimulus when they press the device |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pavlok wristband with electric stimulusit 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 | Other | Pavlok wristband with electric stimulus |
| Pavlok wristband without electric stimulusit 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. | Other | Pavlok wristband without electric stimulus |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Percentage of participants that made a quit attempt
Time frame: From T=0 to one week
Percentage of participants that made a quit attempt
Time frame: From T=1 week to 2 weeks
Percentage of participants that made a quit attempt
Time frame: From T= 2 weeks to 3 weeks
Average Degree of smoking reduction
Time frame: From baseline to 3 months
Percentage of participants who had cessation of smoking.
Time frame: T=0 to T= 3 weeks
Before and after smoking self-efficacy score
Time frame: Baseline to 3 months
Stage of change
Time frame: From baseline until 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Rochford, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pavlok wristband with electric stimulus and Pavlok wristband without electric stimulus in people with Smoking Cessation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants acceptability: short customized survey (time frame: T=0 to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.