Health TrialsbyHealthPanel

Impact of Sweeteners on the Addictive Threshold of Nicotine

ConditionSmoking ( Cigarette)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-59
SponsorYale University

About this trial

To determine if sucralose, an artificial sweetener, modulates nicotine threshold doses for discrimination, subjective-rewarding effects, and reinforcement in smokers with varying levels of dependence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test. Smokers will be stratified by level of dependence, assessed with the FTND 29 low or no dependence ≤3 and moderate or high dependence ≥ 4.

In good health as verified by medical history, screening examination, and screening laboratory tests.

For women, report using acceptable birth control methods.

Disqualifiers

History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study;

regular current use of certain psychotropic medications (such as mood stabilizers, antipsychotics, or anxiolytics being prescribed to treat bipolar disorder, psychosis or anxiety spectrum disorders, respectively);

current untreated alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine;

for women, pregnant as determined by pregnancy screening, or breastfeeding; and 5) seeking (or undergoing) treatment for tobacco dependence or smoking.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Nicotine 0.05 mg/pulse and 0.1 mg/pulse

    Drug

    Nicotine will be used and compared to saline given by IV push by study physician

  • Saline Placebo (0.5mL injection)

    Drug

    Saline will be used compared to the low dose of Nicotine given by IV push by study physician

  • sucralose

    Dietary supplement

    sweet flavor (sucralose) compared to unsweetened flavor

  • Sugar syrup (Placebo)

    Dietary supplement

    Unsweetened flavor compared to the sweetened flavor sucralose.

Treatment groups

36 Participants
are divided into 4 treatment groups
Group A: NicotineActive comparator 1 intervention
Group B: salinePlacebo comparator 1 intervention
Group C: sucraloseActive comparator 1 intervention
Group D: unsweetened flavorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Drug Discrimination Scale (DDS) score.

This scale asks the participants to select if they received Drug A or B and how confident they are in their selection on a scale of 0 to 10. Higher scores indicate more confidence.

Time frame
OnTest Days 1, 2, 3 and 4
2

Drug Effects Questionnaire (DEQ) pleasurable effects score

The DEQ pleasurable effects consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects.

Time frame
OnTest Days 1, 2, 3 and 4

Secondary outcomes

1

Minnesota Nicotine Withdrawal Scale score

This 8-item scale will be used to assess DSM-IV symptoms of nicotine withdrawal. Total score range 0-32. Higher scores indicate more severe withdrawal symptoms.

Time frame
OnTest Days 1, 2, 3 and 4

Other outcomes

Sponsors and contacts

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

Yale University

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: