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

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ClinicalTrials.gov Identifier: NCT03496116
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Other: ECIG Session Not Applicable

Detailed Description:
Electronic cigarettes (ECIGs) are a popular and rapidly evolving class of products. ECIG users can manipulate several device features including liquid nicotine concentration (mg/ml) and heating element resistance (ohms). An emerging class of ECIG models includes "sub-Ohm" devices that employ low resistance heaters that are often used to achieve high device power. Some clinical laboratory data suggest that high power devices deliver nicotine to the user effectively, even when paired with a low liquid nicotine concentration. However, given that ECIG heater resistance and liquid nicotine concentration have not been manipulated in clinical laboratory studies, the influence of these factors on ECIG acute effects remain unclear. The purpose of this clinical laboratory study is to measure the influence of heater resistance and liquid nicotine concentration on ECIG acute effects. Participants will attend the lab for four experimental sessions where they use an ECIG. For each session, the participants will be randomly assigned (like the flip of a coin) to receive an ECIG with one of two different levels of heating coil resistance (which will determine overall device power) and one of two different liquid nicotine concentrations. The four sessions will begin at approximately the same time each day, will be separated by at least 48 hours, and will not occur more than two times per week. The primary hypotheses are that the low resistance heater paired with the 8 mg/ml liquid nicotine concentration, will result in greater nicotine delivery and subjective effect profiles, suggestive of higher abuse potential. Results from this study will further our understanding of the factors that influence the dependence potential of ECIGs and could inform future regulation of these devices.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Influence of Electronic Cigarette Heater Resistance on Nicotine Delivery, Heart Rate, Subjective Effects and Puff Topography
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: ECIG Session: 0.5 Ohms, 3 mg
Heating coil resistance 0.5 Ohms Liquid nicotine concentration 3 mg
Other: ECIG Session
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.

Experimental: ECIG Session 0.5 Ohms, 8 mg
Heating coil resistance 0.5 Ohms Liquid nicotine concentration 8 mg
Other: ECIG Session
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.

Experimental: ECIG Session 1.5 Ohms, 3 mg
Heating coil resistance 1.5 Ohms Liquid nicotine concentration 3 mg
Other: ECIG Session
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.

Experimental: ECIG Session 1.5 Ohms, 8 mg
Heating coil resistance 1.5 Ohms Liquid nicotine concentration 8 mg
Other: ECIG Session
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.




Primary Outcome Measures :
  1. Cmax: Plasma nicotine concentration (ng/ml) [ Time Frame: 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 Outcome Measures :
  1. Withdrawal suppression: Hughes-Hatsukami Withdrawal Scale [ Time Frame: 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. ]
    Contains 11 items. Administered on a computerized visual analogue scale that consists of a phrase centered on a horizontal line with "not at all" on the left and "extremely" on the right.. Responses range from 0-100.

  2. Withdrawal suppression: Direct effects of nicotine scale [ Time Frame: 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. ]
    Contains 9-items. Administered on a computerized visual analogue scale that consists of a phrase centered on a horizontal line with "not at all" on the left and "extremely" on the right.. Responses range from 0-100.

  3. Withdrawal suppression: Tiffany Drobes Questionnaire of Smoking Urges [ Time Frame: 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. ]
    Contains 10 items. Participants will be asked to rate each phrase on a 7-point scale ranging from 0 (Strongly disagree) to 7 (Strongly agree). The items from this scale will form two factors: Factor 1 (intention to smoke) and Factor 2 (anticipation of relief from abstinence symptoms).

  4. Withdrawal suppression: Direct effects of ECIG use scale [ Time Frame: 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. ]
    Contains 14-items. Administered on a computerized visual analogue scale that consists of a phrase centered on a horizontal line with "not at all" on the left and "extremely" on the right. Responses range from 0-100.

  5. Other subjective effects: General Labeled Magnitude Scale [ Time Frame: 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. ]
    Contains 4-items. This category-ratio scale contains seven semantic labels that increase in sensitivity including: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable sensation of any kind." Responses will be coded on a 0-100 scale.

  6. Other subjective effects: Labeled Hedonic Scale [ Time Frame: 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. ]
    Contains 4-items. This category-ratio scale contains ten semantic labels, intended to assess participant liking or disliking of sensations experienced in the general labeled magnitude scale.. Semantic labels include: "most liked sensation imaginable", "like extremely", "like very much", "like moderately", "like slightly", "dislike slightly", "dislike moderately", "dislike very much", "dislike extremely" and "most disliked sensation imaginable". Responses will be coded on a 0-100 scale.

  7. Puff Topography: puff duration [ Time Frame: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes. ]
    Puff duration is the measurement of the length of participant puffs in seconds during a 10-puff directed puffing bout (lasting 5-minutes) and during the 60-minute ad libitum bout where participants are instructed to puff as much or as little as they like on the ECIG.

  8. Puff Topography: puff volume [ Time Frame: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes. ]
    Puff volume is the measurement of the size of participant puffs in milliliters during a 10-puff directed puffing bout (lasting 5-minutes) and during the 60-minute ad libitum bout where participants are instructed to puff as much or as little as they like on the ECIG.

  9. Puff Topography: puff velocity [ Time Frame: Collected twice at each of the 4 visits. During each session, puff duration is measured at 95 and 225 minutes. ]
    Puff velocity is the measurement of the speed of participant puffs in milliliters per second during a 10-puff directed puffing bout (lasting 5-minutes) and during the 60-minute ad libitum bout where participants are instructed to puff as much or as little as they like on the ECIG.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496116


Contacts
Contact: Marzena M Hiler, M.S. 714-512-1647 hilermm@vcu.edu
Contact: Thomas E Eissenberg, PhD 804-827-4617 teissenb@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Barbara Kilgalen, R.N.    804-827-3562    bkigalen@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Thomas E Eissenberg, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03496116     History of Changes
Other Study ID Numbers: HM20012671
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action