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Addictive Threshold of Nicotine

Primary Purpose

Smoking Addiction

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking Addiction

Eligibility Criteria

21 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion 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. Exclusion Criteria: 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.

Sites / Locations

  • VA Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nicotine

saline

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2023
Last Updated
October 17, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT06096714
Brief Title
Addictive Threshold of Nicotine
Official Title
Addictive Threshold of Nicotine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.
Detailed Description
The purpose of this project is to determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, and reinforcement in smokers with different levels of dependence. Participants will have an 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 to be administered by the research staff. Reinforcement will be assessed with the percentage of nicotine choices during the Choice trials. The discrimination is the percentage of correctly identified nicotine and saline infusions. Rewarding effects will be assessed with the "Pleasurable Effects" composite score of the Drug Effects Questionnaire (DEQ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Addiction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nicotine
Arm Type
Active Comparator
Arm Description
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).
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
Nicotine and saline will be infused using a pump.
Primary Outcome Measure Information:
Title
correctly identifying nicotine
Description
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.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Minnix, B.S
Phone
203-932-5711
Email
stacy.minnix@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet S Sofuoglu, M.D.,Ph.D.
Phone
203-932-5711
Email
Mehmet.sofuoglu@yale.edu
Facility Information:
Facility Name
VA Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Sullivan
Phone
203-932-5711
Email
Brendan.sullivan@va.gov
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, M.D.,Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Addictive Threshold of Nicotine

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