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IV Nicotine Induced Changes in Hormone Function, Mood States and Behavior

NCT01589055 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-17

No results posted yet for this study

Summary

Clinical studies are proposed to analyze the interactions between nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies are designed to examine the contribution of gender and menstrual cycle phase. It is hypothesized that analysis of nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing understanding of the neurobiology of nicotine reinforcement.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Intravenous Nicotine

Subjects will be given an intravenous challenge dose of nicotine or placebo in a constant volume of 1 ml on any study day. The nicotine solution (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (1 ml over 1 min) has been safe in our IRB approved studies of nicotine. Most investigators have administered nicotine over 10 sec without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg and 1.5 mg/70kg;) should be administered first and the higher dose (2.0 mg/70kg) will be administered last.

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Nancy K M, PhD · Mclean Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2015-12-01
Completion
2015-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589055 on ClinicalTrials.gov