NCT06096714

Brief Summary

To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

October 12, 2023

Last Update Submit

April 28, 2026

Conditions

Smoking Addiction

Outcome Measures

Primary Outcomes (1)

  • correctly identifying nicotine

    Reinforcement will be assessed with the percentage of nicotine doses chosen during the Choice trials (out of 16), 4 choices per day over four days.

    up to 8 weeks

Study Arms (2)

Nicotine

ACTIVE COMPARATOR

Adaptation Session followed by 4 Test Days. The Adaptation Session will familiarize the participants with study procedures. In each Test Day, a different nicotine dose (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) will be compared to saline for nicotine discrimination, subjective effects, and reinforcement. Participants will first sample the assigned nicotine dose and saline, followed by 4 trials to test their ability to discriminate it from saline. This will be followed by 4 Choice trials where participants will be able to choose between nicotine (at the session-assigned dose) or saline (A or B).

Drug: NicotineOther: Saline

saline

PLACEBO COMPARATOR

Subjects will have sample A and B, one being nicotine and one being saline. The doses will be blinded from PI, subject and staff. The subject must choose A or B for the next ten choices.

Drug: NicotineOther: Saline

Interventions

NicotineDRUG

Nicotine will be infused using a pump.

Nicotinesaline
SalineOTHER

Saline with be used to compare Nicotine, Saline will be infused using a pump

Nicotinesaline

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to contact their primary care provider when necessary.
  • Adults, aged 21 to 59 years. Individuals less than 21 will be excluded because the minimum age for purchasing tobacco products is 21 in our state. The upper age is set at 59 because there are no previous IV nicotine studies that enrolled smokers over the age of 59.
  • 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 based on the level of dependence, assessed with the FTND scores (Heatherton et al. 1991) (low or no dependence 4 and moderate or high level of dependence 5.
  • In good health as verified by medical history, screening examination, and screening laboratory tests.
  • For women, report using acceptable birth control methods.

You may not qualify if:

  • 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
  • seeking (or undergoing) treatment for tobacco dependence or smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Interventions

NicotineSodium Chloride

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 24, 2023

Study Start

February 27, 2024

Primary Completion

March 27, 2026

Study Completion

March 27, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)