Evaluation of the Electronic Cigarette Withdrawal Syndrome

• ClinicalTrials.gov Identifier: NCT06066996
• Recruitment Status: Recruiting
• First Posted: October 4, 2023
• Last Update Posted: December 6, 2023
• Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: September 28, 2023
• First Posted Date: October 4, 2023
• Last Update Posted Date: December 6, 2023
• Actual Study Start Date: November 28, 2023
• Estimated Primary Completion Date: August 31, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2023)

• Change in Hughes-Hatsukami Withdrawal Scale [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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 [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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) [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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) [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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 [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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 [ Time Frame: Nightly up to seven days ]
  Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
• Total time spent in Rapid eye movement (REM) sleep [ Time Frame: Nightly up to seven days ]
  Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
• Wake after sleep onset (WASO) [ Time Frame: Nightly up to seven days ]
  Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 28, 2023)

• Change in E-Cigarette Demand Intensity [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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 [ Time Frame: Baseline, every 4 hours up to 16 hours ]
  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 [ Time Frame: Day 14 ]
  Return to e-cigarette use at the one week follow-up.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Electronic Cigarette Withdrawal Syndrome
• Official Title: Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention
• 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.
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• E-cigarette Use
• Withdrawal

Intervention

• Drug: Transdermal Nicotine Patch
  Blinded Nicotine Patch
• Drug: Placebo Nicotine Patch
  Blinded Patch with No Nicotine

Study Arms

• Experimental: Transdermal Nicotine Patch
  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.
  Intervention: Drug: Transdermal Nicotine Patch
• Placebo Comparator: Transdermal Placebo Patch
  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.
  Intervention: Drug: Placebo Nicotine Patch
• No Intervention: No Patch
  Participants assigned to this condition will not receive a patch.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 28, 2023): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2028
• Estimated Primary Completion Date: August 31, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. 21-55 years old
2. good general health as reviewed by study medical team
3. vital signs in normal range as reviewed by study medical team
4. negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
5. daily use of a nicotine-containing e-cigarette for at least 6 months
6. no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
7. urine cotinine >100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
8. exhaled breath carbon monoxide (CO) <6ppm
9. Penn State E-cigarette Dependence (PSED) score >=4, indicating mild dependence or greater
10. have an interest in reducing e-cigarette use

Exclusion criteria:

1. psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
2. current use of over-the-counter (OTC) or prescription medications that may impact safety
3. use cannabis >2 times per week
4. history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
5. 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
6. enrollment in another trial
7. positive pregnancy test
8. currently using a nicotine/tobacco cessation product
9. seizure disorder or traumatic brain injury (TBI)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Justin Strickland, Ph.D.; 4105501975; jstric14@jhmi.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06066996
• Other Study ID Numbers: IRB00407275; R01DA057925 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Same as current
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Justin Strickland, Ph.D.; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: November 2023