RECRUITING

Addictive Threshold of Nicotine

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Addictive Threshold of Nicotine

Quick Facts

Study Start:2024-02-27

Study Completion:2027-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06096714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Stacy Minnix, B.S

CONTACT

203-932-5711

stacy.minnix@yale.edu

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

CONTACT

203-932-5711

Mehmet.sofuoglu@yale.edu

Study Locations (Sites)

VA Healthcare System

West Haven, Connecticut, 06516

United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-27

Study Completion Date2027-01-30

Study Record Updates

Study Start Date2024-02-27

Study Completion Date2027-01-30

Terms related to this study

Additional Relevant MeSH Terms

Smoking Addiction