A study to assess if nicotine delivered via an e-cigarette can have an effect on cognitive function in healthy adult smokers

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: The order of the Investigational Product use will be randomised (using a Williams Latin square design) for this 5‐period cross over study. The Investigational Products in this study are as follows: 1. No Treatment (Control 1) 2. Combustible Cigarette (Control 2) 3. EPEN3.0_VGT00 (Placebo 1) 4. EPEN3.0_VGT12 (Intervention 1) 5. EPEN3.0_VGT18 (Intervention 2) Each participant will use the e‐Cigarette or cigarette for a 5 min session of ad‐libitum puffing regimen (puffing as participants feel necessary for 5 min). Participants will use one Investigational Product per study session. There will be 5 study sessions for each participant. Participants will abstain from nicotine, caffeine, and alcohol 12 h prior to the start of each study session. There will be at least 7 days between the administrations of each study session. CONDITION: Cigarette smoking ; Not Applicable PRIMARY OUTCOME: ; 1. Sustained Attention as assessed via completion of the Rapid Visual Information Processing (RVP) task on the CANTAB software at 85 mins prior to and 0 mins after product usage; 2. Working Memory as assessed via completion of the Spatial Working Memory (SWM) task on the CANTAB software at 85 mins prior to and 0 mins after product usage; 3. Executive Function as assessed via completion of the One Touch Stockings of Cambridge (OTS) task on the CANTAB software at 85 mins prior to and 0 mins after product usage; 4. Episodic Memory as assessed via completion of the Paired Associates Learning (PAL) task on the CANTAB software at 85 mins prior to and 0 mins after product usage; SECONDARY OUTCOME: ; 1. Subjective Emotion – assessed via the Subjective Emotion Questionnaire (VAS) ‐ at 45 mins prior to and 40 mins after product usage; 2. Subjective Craving – assessed via Questionnaire on Subjective Urges (QSU) Brief – at 45 mins prior to and 40 mins after product usage; INCLUSION CRITERIA: 1. Healthy male or female subject, between 25 and 45 years of age, inclusive. 2. Female subject of childbearing potential willing to use a highly effective method of contraception or 2 effective methods of contraception if applicable (unless of non‐childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from screening until the post study follow up phone call. 3. Female subject of non‐childbearing potential. For the purposes of this study, this is defined as the subject being amenorrhoeic for at least 12 consecutive months or at least 4 months post‐surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy; documentation of the procedure is required). 4. Female subject with a negative pregnancy test at Screening who is not breastfeeding or lactating.<
Epistemonikos ID: cccc23aae8ed0102de4ed5d928f1c9ca192fa3b9
First added on: Oct 16, 2021