Evaluation of the Electronic Cigarette Withdrawal Syndrome

E-cigarette Use Clinical Trial

Official title:

Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066996
• Other study ID #: IRB00407275
• Secondary ID: R01DA057925
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 28, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: Justin Strickland, Ph.D.
• Phone: 4105501975
• Email: jstric14[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• E-cigarette Use
• Substance Withdrawal Syndrome
• Withdrawal

Intervention

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

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, every 4 hours up to 16 hours
Primary	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.	Baseline, every 4 hours up to 16 hours
Primary	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.	Baseline, every 4 hours up to 16 hours
Primary	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.	Baseline, every 4 hours up to 16 hours
Primary	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.	Baseline, every 4 hours up to 16 hours
Primary	Total sleep time	Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.	Nightly up to seven days
Primary	Total time spent in Rapid eye movement (REM) sleep	Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.	Nightly up to seven days
Primary	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.	Nightly up to seven days
Secondary	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.	Baseline, every 4 hours up to 16 hours
Secondary	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.	Baseline, every 4 hours up to 16 hours
Secondary	Return to Use	Return to e-cigarette use at the one week follow-up.	Day 14