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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06066996
Other study ID # IRB00407275
Secondary ID R01DA057925
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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