The Influence of Electronic (ECIG) Heater Resistance on ECIG Acute Effects

NCT03496116 | Completed

• 1 other identifier: HM20012671
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the individual and combined influence of electronic cigarette (ECIG) heating element resistance and liquid nicotine concentration on ECIG acute effects. Thirty-two experienced ECIG users will complete four independent laboratory sessions that will differ by heater resistance (0.5 ohm or 1.5 ohm) and liquid nicotine concentration (3 or 8 mg/ml). Other factors such as voltage, liquid solvent ratio, and liquid flavor will be held constant. Plasma nicotine concentration, subjective effects, and puffing behavior will be recorded for each condition.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Cmax: Plasma nicotine concentration (ng/ml)

  Six blood samples are collected at each of the 4 visits. During each session, blood samples are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.

Secondary Outcomes (9)

• Withdrawal suppression: Hughes-Hatsukami Withdrawal Scale

  Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.

• Withdrawal suppression: Direct effects of nicotine scale

  Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.

• Withdrawal suppression: Tiffany Drobes Questionnaire of Smoking Urges

  Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.

• Withdrawal suppression: Direct effects of ECIG use scale

  Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.

• Other subjective effects: General Labeled Magnitude Scale

  Collected six times at each of the 4 visits. During each session, questions are collected 90,100,160,185,205,225 minutes into the session which lasts approximately 4 hours.

Study Arms (4)

ECIG Session: 0.5 Ohms, 3 mg

EXPERIMENTAL

Heating coil resistance 0.5 Ohms Liquid nicotine concentration 3 mg

Other: ECIG Session

ECIG Session 0.5 Ohms, 8 mg

EXPERIMENTAL

Heating coil resistance 0.5 Ohms Liquid nicotine concentration 8 mg

Other: ECIG Session

ECIG Session 1.5 Ohms, 3 mg

EXPERIMENTAL

Heating coil resistance 1.5 Ohms Liquid nicotine concentration 3 mg

Other: ECIG Session

ECIG Session 1.5 Ohms, 8 mg

EXPERIMENTAL

Heating coil resistance 1.5 Ohms Liquid nicotine concentration 8 mg

Other: ECIG Session

Interventions

ECIG Session OTHER

Participants will complete four sessions using an e-cigarette, including a 10-puff product use bout followed by a 60-minute ad lib bout over an approximately 4-hour period. The study conditions for each session (i.e., heater resistance and nicotine combinations) will be Latin-square ordered.

ECIG Session 0.5 Ohms, 8 mg; ECIG Session 1.5 Ohms, 3 mg; ECIG Session 1.5 Ohms, 8 mg; ECIG Session: 0.5 Ohms, 3 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to provide informed consent, attend the lab and abstain from nicotine/tobacco as required, and use designated products according to study protocol
• Experienced ECIG users (use ≥1 ml of ECIG solution daily, use ECIG solution with a nicotine concentration ≥3 mg/ml, and have used their ECIG for ≥3 months)
• Urine cotinine test result ≥ 3

You may not qualify if:

• History of organ-related diseases or current psychiatric condition
• Regular use of prescription medication other than vitamins or birth control
• Past month use of cocaine, opioids, benzodiazepines, or methamphetamine
• Using marijuana greater than 10 days in the past 30 and/or alcohol greater than 25 days in the past 30 days
• Pregnant or breastfeeding women
• Weight less than 110 pounds
• Daily use of \>5 cigarettes or use of other tobacco products (i.e., hookah, cigars) \>3 times a week

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Thomas E Eissenberg, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 12, 2018
• Study Start: May 21, 2018
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: May 9, 2019

Record last verified: 2019-05

Locations

US (1)