Evaluation of the Electronic Cigarette Withdrawal Syndrome

NCT ID: NCT06066996

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2028-06-30

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.

Conditions

E-cigarette Use; Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transdermal Nicotine Patch

Intervention Type: DRUG

Blinded Nicotine Patch

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.

Group Type: PLACEBO_COMPARATOR

Placebo Nicotine Patch

Intervention Type: DRUG

Blinded Patch with No Nicotine

No Patch

Participants assigned to this condition will not receive a patch.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transdermal Nicotine Patch

Blinded Nicotine Patch

Intervention Type: DRUG

Placebo Nicotine Patch

Blinded Patch with No Nicotine

Intervention Type: DRUG

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin Strickland, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Justin Strickland, Ph.D.

Role: CONTACT

jstric14@jhmi.edu

4105501975

Facility Contacts

Justin Strickland, Ph.D.

Role: primary

jstric14@jhmi.edu

410-550-1975

Other Identifiers

R01DA057925

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00407275

Identifier Type: -

Identifier Source: org_study_id