Evaluation of the Electronic Cigarette Withdrawal Syndrome
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transdermal Nicotine Patch
DrugBlinded Nicotine Patch
Placebo Nicotine Patch
DrugBlinded Patch with No Nicotine
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Transdermal Nicotine PatchExperimental treatment 1 intervention
Group B: Transdermal Placebo PatchPlacebo comparator 1 intervention
Group C: No PatchNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, every 4 hours up to 16 hours2
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.
Time frame
Baseline, every 4 hours up to 16 hours3
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.
Time frame
Baseline, every 4 hours up to 16 hours4
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.
Time frame
Baseline, every 4 hours up to 16 hoursSecondary outcomes
1
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.
Time frame
Baseline, every 4 hours up to 16 hours2
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.
Time frame
Baseline, every 4 hours up to 16 hours3
Return to Use
Return to e-cigarette use at the one week follow-up.
Time frame
Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov