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Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect

NCT01589081 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-17

No results posted yet for this study

Summary

The proposed clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. It is hypothesized that the administration of progesterone at a dose that mimics luteal phase levels in normal cycling women will diminish the positive subjective effects of nicotine, as has been consistently observed for cocaine. This novel approach could have direct implications for facilitating smoking cessation treatment in women of reproductive age

Conditions

  • Nicotine Dependence

Interventions

DRUG

Intravenous Nicotine

Subjects will be given an IV challenge dose of nicotine or placebo in a constant volume of 2 mL on any study session day. The nicotine solutions (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 (2 mL over one minute) has been safe in our IRB-approved studies of nicotine. Most investigators have administered nicotine over 10 seconds without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg; and 1.5 mg/70kg) will be administered first and the higher dose (2.0 mg/70kg) will be administered last.

DRUG

Progesterone

To stimulate the luteal phase of the menstrual cycle, Prometrium capsules containing 200 mg of micronized progesterone or placebo (lactose containing) capsules will be administered orally at 120 minutes before the injection of IV nicotine.

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Nancy K Mello, PhD · Mclean Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
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 NCT01589081 on ClinicalTrials.gov