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

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

Treatments tested in this trial

Nicotine 0.05 mg/pulse and 0.1 mg/pulse
Saline Placebo (0.5mL injection)
sucralose
Sugar syrup (Placebo)

Treatment groups

36 Participants

are divided into 4 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov