Impact of Sweeteners on the Addictive Threshold of Nicotine

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07771725
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Smoking ( Cigarette)

Eligibility Criteria

Sex
ALL
Age
21 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Nicotine
    These test days will evaluate two nicotine doses (0.05 mg/pulse and 0.1 mg/pulse)
  • Placebo Comparator: saline
    Saline (sugar water)
  • Active Comparator: sucrolose
    participants practice using the e-cigarette and sample the sweet (sucralose) and control (unsweetened) flavors
  • Placebo Comparator: unsweetened flavor
    participants practice using the e-cigarette and sample the sweet (sucralose) and control (unsweetened) flavors

Primary Outcome Measure

Drug Discrimination Scale (DDS) score. [ Time Frame: OnTest Days 1, 2, 3 and 4 ]

Central Contacts

  • Mehmet Sofuoglu, M.D., Ph.D.
    203-932-5711
    [email protected]
  • Stacy A Minnix, B.S.
    203--932-5711

Locations (1)

FacilityCityStateZIPSite coordinators
VA HospitalWest HavenConnecticut06516-

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By research site
VA Hospital· West Haven, CT

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