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Sweeteners for Smoking

MS
SA
Overseen ByStacy A Minnix, B.S.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Yale University
Must not be taking: Mood stabilizers, Antipsychotics, Anxiolytics
Disqualifiers: Major medical, Psychiatric disorders, Untreated substance use, Pregnant, others

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

MS

Mehmet Sofuoglu, M.D., Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults who smoke cigarettes. Participants should not have major health issues that could interfere with the study, and must be able to safely receive nicotine and sweetener products.

Inclusion Criteria

Smokers stratified by level of dependence assessed with FTND: low or no dependence ≤3 and moderate or high dependence ≥4
Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test
For women, report using acceptable birth control methods
See 1 more

Exclusion Criteria

I am currently pregnant or breastfeeding.
History of major medical or psychiatric disorders contraindicated for study participation as deemed by physician investigator
Seeking or undergoing treatment for tobacco dependence or smoking
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Adaptation Session

Participants familiarize themselves with all study procedures

1 day
1 visit (in-person)

Test Days

Participants undergo four test days where they receive specific nicotine doses paired with sucralose or control flavor

4 days
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the test days

2 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests whether sucralose (an artificial sweetener) changes how smokers respond to small doses of nicotine compared to sugar syrup or saline placebo. Different nicotine doses are given in a controlled setting.

How Is the Trial Designed?

4

Treatment groups

Active Control

Placebo Group

Group I: NicotineActive Control1 Intervention
Group II: sucraloseActive Control1 Intervention
Group III: salinePlacebo Group1 Intervention
Group IV: unsweetened flavorPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

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