Clinical trial NCT03450148: Aversive Therapy for Smoking Cessation
Official title: Acceptability and Feasibility of Self Administered Aversive Therapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: aversive therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participants acceptability: short customized survey
timeFrame: T=0 to 3 months
measure: Evaluate the dropout among participants
timeFrame: T=0 to 3 months
measure: Enrollment percentage of eligible participants
timeFrame: Baseline to T=0
measure: Percentage of time wristband worn by participants
timeFrame: T=0 to one week
measure: Percentage of time wristband worn by participants
timeFrame: from one week to two weeks
measure: Percentage of time wristband worn by participants
timeFrame: from two week to three weeks
measure: Participants satisfaction: short customized survey
timeFrame: T=0 to 3 months
Secondary outcomes:
measure: Percentage of participants that made a quit attempt
timeFrame: From T=0 to one week
measure: Percentage of participants that made a quit attempt
timeFrame: From T=1 week to 2 weeks
measure: Percentage of participants that made a quit attempt
timeFrame: From T= 2 weeks to 3 weeks
measure: Average Degree of smoking reduction
timeFrame: From baseline to 3 months
measure: Percentage of participants who had cessation of smoking.
timeFrame: T=0 to T= 3 weeks
measure: Before and after smoking self-efficacy score
timeFrame: Baseline to 3 months
measure: Stage of change
timeFrame: From baseline until 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univeristy of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Rochford, MD
role: PRINCIPAL_INVESTIGATOR
References: