Health TrialsbyHealthPanel

Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches

ConditionNicotine Addiction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-35
SponsorEmory University

About this trial

The goal of this study is to assess the effects of nicotine concentration and its interplay with pH on sensory experience, product appeal, and abuse liability of NPs among young adults NP users.

Primary objective is to assess the effect of variation in nicotine concentration in nicotine pouches (NPs) and its interaction effect with pH level on three proximal outcomes of relevance to regulation: (1) sensory experience, (2) product appeal, and (3) abuse liability of NPs.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Current established users of nicotine pouches (have used nicotine pouches in the past 30 days & currently use nicotine pouches every day or someday)

Positive cotinine test via saliva test strip

Those who are unmotivated to quit nicotine use

Read and speak English.

Disqualifiers

Planning to cut down or quit using nicotine in the next 30 days

Currently pregnant or breastfeeding

History of stroke, seizures, high blood pressure, heart disease/problems, or cardiovascular disease contraindications for nicotine.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nicotine pouch: Low dose

    Other intervention

    Nicotine pouch: 3-4 mg

  • Nicotine pouch: High dose

    Other intervention

    Nicotine pouch: 6-8 mg

  • Low pH

    Other intervention

    Nicotine pouch with low pH level \[\<8.5\]

  • High pH

    Other intervention

    Nicotine pouch with high pH level \[\>8.5\]

Treatment groups

84 Participants
are divided into 1 treatment group
Group A: Nicotine Pouches groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Abuse liability: Amount of time with Nicotine product

Total amount of time with Nicotine Pouches in mouth (excluding periods in between NPs after disposal)

Time frame
Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
2

Abuse liability: Number of Nicotine Pouches used

Total number of Nicotine Pouches used (i.e., larger number and longer time with Nicotine Pouches, higher abuse ability.

Time frame
Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
3

Subjective effects measures: Drug Effects Questionnaire

During the session, participants will also repeatedly (every 30 min) complete the subjective effects measures of abuse liability of NP (using VAS), which will be developed based on the Drug Effects Questionnaire (DEQ). A modified version of the DEQ will be used to rate acute responses to the NP on the Visual Analogue Scale (range, 0-100). Items assess liking/wanting (e.g., "I enjoy nicotine buzz," "I feel good effects from the NP," "I want more," "I feel the NP strength," and "I like the NP effect").

Time frame
Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
4

Subjective effects measures: Modified Cigarette Evaluation Questionnaire

Modified Cigarette Evaluation Questionnaire will also be used to measure domains of subjective reinforcing effects (product satisfaction, psychological reward; e.g., "NP is satisfying" on a 7-point scale (0-7).

Time frame
Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)

Secondary outcomes

1

Nicotine product use history: Number of days

Information will be collected on past 30-day number of days used nicotine pouches (NPs)

Time frame
past 30-day
2

Nicotine product use history: Number of Nicotine product

Number of Nicotine product used per day

Time frame
past 30-day
3

Nicotine product use history: Amount of time with Nicotine product

Amount of time with Nicotine product in mouth per episode

Time frame
past 30-day
4

Nicotine Pouches brand

Data on brand names of NPs will be collected

Time frame
past 30-day

Other outcomes

1

Salivary cotinine

Test strips that provide a semiquantitative index of salivary cotinine will be collected to provide descriptive data on nicotine exposure.

Time frame
Baseline

Sponsors and contacts

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

Emory University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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