Back to resultsEvaluation of the Electronic Cigarette Withdrawal Syndrome
Primary Purpose
E-cigarette Use, Withdrawal
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transdermal Nicotine Patch
Placebo Nicotine Patch
Sponsored by
About this trial
This is an interventional basic science trial for E-cigarette Use
Eligibility Criteria
Inclusion criteria: 21-55 years old good general health as reviewed by study medical team vital signs in normal range as reviewed by study medical team negative urine test for illicit drug use (excluding THC) and negative breath alcohol test daily use of a nicotine-containing e-cigarette for at least 6 months no regular use of other tobacco products (e.g., smokeless products) for at least 6 months urine cotinine >100ng/mL (i.e., recommended cutoff for confirming current nicotine use) exhaled breath carbon monoxide (CO) <6ppm Penn State E-cigarette Dependence (PSED) score >=4, indicating mild dependence or greater have an interest in reducing e-cigarette use Exclusion criteria: psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month current use of over-the-counter (OTC) or prescription medications that may impact safety use cannabis >2 times per week history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff enrollment in another trial positive pregnancy test currently using a nicotine/tobacco cessation product seizure disorder or traumatic brain injury (TBI)
Sites / Locations
- Behavioral Pharmacology Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Transdermal Nicotine Patch
Transdermal Placebo Patch
No Patch
Arm Description
Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.
Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions.
Participants assigned to this condition will not receive a patch.
Outcomes
Primary Outcome Measures
Change in Hughes-Hatsukami Withdrawal Scale
The Hughes-Hatsukami Withdrawal Scale consists of 13 items presented individually on a 100mm visual analog scale. Higher scores reflect higher withdrawal (worse outcome) [range 0-32]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief
The Tiffany-Drobes QSU Brief consists of ten items, each presented on the screen as a phrase centered above seven boxes ranging from (strongly disagree) to (strongly agree). Higher scores reflect higher withdrawal (worse outcome) [range 0-70]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Positive and Negative Affect Schedule (PANAS)
The PANAS consists of 20 items presented individually on a five-point Likert scale. Higher scores reflect more positive affect and negative affect [range 0-50]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Conners' Continuous Performance Task (CPT)
On the CPT, participants respond to single letters appearing on their computer screen but are asked to refrain from responding to a specified letter(i.e., the letter X). Higher scores reflect more inattention. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Memory as assessed by the N-Back
On the n-back, participants decide whether each stimulus in a sequence matches the one that appeared "n" items ago. Higher scores reflect more accuracy. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Total sleep time
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Total time spent in Rapid eye movement (REM) sleep
Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
Wake after sleep onset (WASO)
Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.
Secondary Outcome Measures
Change in E-Cigarette Demand Intensity
E-cigarette use at unconstrained price measured using a commodity purchase task. Higher scores reflect more demand (worse outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in E-Cigarette Demand Elasticity
Sensitivity of e-cigarette use to price measured using a commodity purchase task. Higher scores reflect more price sensitivity (better outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Return to Use
Return to e-cigarette use at the one week follow-up.
Full Information
NCT ID
NCT06066996
First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT06066996
Brief Title
Evaluation of the Electronic Cigarette Withdrawal Syndrome
Official Title
Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.
Detailed Description
This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
E-cigarette Use, Withdrawal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transdermal Nicotine Patch
Arm Type
Experimental
Arm Description
Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.
Arm Title
Transdermal Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions.
Arm Title
No Patch
Arm Type
No Intervention
Arm Description
Participants assigned to this condition will not receive a patch.
Intervention Type
Drug
Intervention Name(s)
Transdermal Nicotine Patch
Intervention Description
Blinded Nicotine Patch
Intervention Type
Drug
Intervention Name(s)
Placebo Nicotine Patch
Intervention Description
Blinded Patch with No Nicotine
Primary Outcome Measure Information:
Title
Change in Hughes-Hatsukami Withdrawal Scale
Description
The Hughes-Hatsukami Withdrawal Scale consists of 13 items presented individually on a 100mm visual analog scale. Higher scores reflect higher withdrawal (worse outcome) [range 0-32]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief
Description
The Tiffany-Drobes QSU Brief consists of ten items, each presented on the screen as a phrase centered above seven boxes ranging from (strongly disagree) to (strongly agree). Higher scores reflect higher withdrawal (worse outcome) [range 0-70]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Change in Positive and Negative Affect Schedule (PANAS)
Description
The PANAS consists of 20 items presented individually on a five-point Likert scale. Higher scores reflect more positive affect and negative affect [range 0-50]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Change in Conners' Continuous Performance Task (CPT)
Description
On the CPT, participants respond to single letters appearing on their computer screen but are asked to refrain from responding to a specified letter(i.e., the letter X). Higher scores reflect more inattention. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Change in Memory as assessed by the N-Back
Description
On the n-back, participants decide whether each stimulus in a sequence matches the one that appeared "n" items ago. Higher scores reflect more accuracy. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Total sleep time
Description
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Time Frame
Nightly up to seven days
Title
Total time spent in Rapid eye movement (REM) sleep
Description
Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
Time Frame
Nightly up to seven days
Title
Wake after sleep onset (WASO)
Description
Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.
Time Frame
Nightly up to seven days
Secondary Outcome Measure Information:
Title
Change in E-Cigarette Demand Intensity
Description
E-cigarette use at unconstrained price measured using a commodity purchase task. Higher scores reflect more demand (worse outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Change in E-Cigarette Demand Elasticity
Description
Sensitivity of e-cigarette use to price measured using a commodity purchase task. Higher scores reflect more price sensitivity (better outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Time Frame
Baseline, every 4 hours up to 16 hours
Title
Return to Use
Description
Return to e-cigarette use at the one week follow-up.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
21-55 years old
good general health as reviewed by study medical team
vital signs in normal range as reviewed by study medical team
negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
daily use of a nicotine-containing e-cigarette for at least 6 months
no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
urine cotinine >100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
exhaled breath carbon monoxide (CO) <6ppm
Penn State E-cigarette Dependence (PSED) score >=4, indicating mild dependence or greater
have an interest in reducing e-cigarette use
Exclusion criteria:
psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
current use of over-the-counter (OTC) or prescription medications that may impact safety
use cannabis >2 times per week
history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff
enrollment in another trial
positive pregnancy test
currently using a nicotine/tobacco cessation product
seizure disorder or traumatic brain injury (TBI)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Strickland, Ph.D.
Phone
4105501975
Email
jstric14@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Strickland, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Strickland, Ph.D.
Phone
410-550-1975
Email
jstric14@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Electronic Cigarette Withdrawal Syndrome
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