Evaluation of the Electronic Cigarette Withdrawal Syndrome

Johns Hopkins University

Status and phase: Enrolling; Early Phase 1

Conditions: Withdrawal; E-cigarette Use

Treatments: Drug: Placebo Nicotine Patch; Drug: Transdermal Nicotine Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06066996

R01DA057925 (U.S. NIH Grant/Contract)

IRB00407275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Transdermal Nicotine Patch

Experimental group

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.

Treatment:

Drug: Transdermal Nicotine Patch

Transdermal Placebo Patch

Placebo Comparator group

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.

Treatment:

Drug: Placebo Nicotine Patch

No Patch

No Intervention group

Description:

Participants assigned to this condition will not receive a patch.