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Understanding Oral Nicotine Pouch Use in Healthy Volunteers

ConditionHealthy Adult Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, San Francisco

About this trial

The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are:

1. With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping. 2. With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping. Participants will rate ONP use as a satisfactory substitute for cigarette smoking or vaping. 3. Examine the cardiovascular effects (blood pressure and heart rate) of placebo, 3mg and 6mg ONPs, and the participants' usual cigarette or e-cigarette (vape).

Participants will:

* use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape) * visit the hospital research ward on 4 separate days for 8 hours each day * use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy based on medical history and limited physical examination.

Heart rate < 105 BPM*

Systolic Blood Pressure < 160 and > 90*

Diastolic Blood Pressure < 100 and > 50*

Disqualifiers

Heart disease

Seizures

Cancer

Thyroid disease (okay if controlled with medication)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 0 mg oral nicotine pouches

    Drug

    placebo

  • 3 mg oral nicotine pouches

    Drug

    low strength oral nicotine pouches

  • 6 mg oral nicotine pouches

    Drug

    high strength oral nicotine pouches

  • cigarette or e-cigarette

    Drug

    Participants will use their own cigarette or e-cigarette (vape)

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: 3 mg ONPExperimental treatment 1 intervention
Group C: 6 mg ONPExperimental treatment 1 intervention
Group D: Inhaled nicotineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.

This will be assessed by comparing ratios of nicotine area under the plasma nicotine concentration time curve.

Time frame
7 hours post-dose

Secondary outcomes

1

With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping.

This will be assessed by administering the Modified Cigarette Evaluation Questionnaire (mCEQ) throughout the day. The mCEQ uses three multi-item subscales and two single items: "Smoking Satisfaction" (items 1, 2, and 12); "Psychological Reward" (items 4 through 8); "Aversion" (items 9 and 10); "Enjoyment of Sensations" (item 3); and "Craving Reduction" (item 11). The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. The minimum total score = 7 and maximum = 35 with higher scores indicating greater intensity on that scale.

Time frame
Pre-dose until 7 hours post-dose.
2

Cardiovascular effects among arms using heart rate as a measure

The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate after the first dose of nicotine over the following 7 hours among dosages.

Time frame
Pre-dose until 7 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: