The Effect of Nicotine Delivery Rate on Reinforcement

NCT03134339 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 1609018390
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.

Conditions

Nicotine

Keywords

nicotine, smoking

Outcome Measures

Primary Outcomes (1)

• Peak Change on items of the Drug Effects Questionnaire (DEQ)

  The peak change in the intensity of subjective effects as measured by the DEQ

  up to 60 minutes post infusion

Study Arms (4)

saline 0.00mcg/kg/s

EXPERIMENTAL

0.00 mcg/kg/s The day order will be randomized per day

Drug: Nicotine saline 0.00mcg/kg/s

0.24mcg/kg/s

EXPERIMENTAL

0.24 mcg/kg/s The day order will be randomized per day

Drug: Nicotine 0.24 mcg/kg/s

0.048mcg/kg/s

EXPERIMENTAL

0.048 mcg/kg/s The day order will be randomized per day

Drug: Nicotine 0.048 mcg/kg/s

0.024 mcg/kg/s

EXPERIMENTAL

0.024 mcg/kg/s The day order will be randomized per day

Drug: Nicotine 0.024 mcg/kg/s

Interventions

Nicotine saline 0.00mcg/kg/s DRUG

saline 0.00mcg/kg/s

Also known as: nicotine infusion

saline 0.00mcg/kg/s

Nicotine 0.24 mcg/kg/s DRUG

nicotine 0.24 mcg/kg/s

Also known as: nicotine infusion

0.24mcg/kg/s

Nicotine 0.048 mcg/kg/s DRUG

nicotine 0.048 mcg/kg/s

Also known as: nicotine infusion

0.048mcg/kg/s

Nicotine 0.024 mcg/kg/s DRUG

nicotine 0.024 mcg/kg/s

Also known as: nicotine infusion

0.024 mcg/kg/s

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female and male smokers that smoke ≥ 5 cigarettes per day for the past year
• aged 18 to 30 years
• urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker (23)
• not seeking treatment at the time of the study for nicotine dependence
• in good health as verified by medical history, screening examination, and screening laboratory tests
• for women, not pregnant as determined by pregnancy screening, nor breast feeding, and 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 subject to be in the study
• regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
• current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
• urine drug screening indicating recent illicit drugs use (with the exception of marijuana).

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kevin Jensen, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Mehmet Sofuoglu, M.D.,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and Investigator will not know nicotine dose or rate of infusion.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The effect of nicotine delivery rate on reinforcement

Model Details: The effects of different IV nicotine delivery rates of (saline), 0.24, 0.048 and 0.024 mcg/kg/s), as a within-subject factor, on peak change in the intensity of subjective effects as measured by the DEQ, will be used as a measured of a reinforcing threshold.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: April 28, 2017
• Study Start: January 5, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)