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

NCT01589081 | Withdrawn

• 1 other identifier: 2008-p-000454
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effects of Progesterone on IV nicotine hormones and mood

  We are examining the effects of progesterone on IV nicotine induced changes in serum/plasma hormone levels and subjective states, as measured by a visual analog scale.

  From baseline to study completion (approximately 1 year)

Study Arms (2)

Female Smokers (Luteal Phase)

ACTIVE COMPARATOR

Drug: Intravenous Nicotine; Drug: Progesterone

Female Smokers (Follicular Phase)

ACTIVE COMPARATOR

Drug: Intravenous Nicotine; Drug: Progesterone

Interventions

Intravenous Nicotine DRUG

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.

Also known as: IV Nicotine

Female Smokers (Follicular Phase); Female Smokers (Luteal Phase)

Progesterone DRUG

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.

Female Smokers (Follicular Phase); Female Smokers (Luteal Phase)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 18 and 40 who currently smoke at least 15 cigarettes every day, and who fulfill DSM-IV diagnostic criteria for nicotine dependence will be eligible for participation.
• No evidence of clinically significant disease based upon complete medical history and physical examination supervised by Dr. Arthur Siegel (Chief of Internal Medicine).
• Absence of DSM-IV Axis I Disorders other than nicotine dependence (305.10) as measured by the Structured Clinical Interview (SCID).
• Routine laboratory blood tests including complete blood count, electrolytes, BUN and creatinine, liver function tests, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but subjects who have hepatitis serology consistent with previous exposure to Hepatitis A, Hepatitis B, or Hepatitis C, but who do not have clinical and biochemical evidence of acute infection, will be acceptable.
• Hematocrit levels ≥ 35% for females.
• Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study session day.
• Normal EKG.
• A Body Mass Index (BMI-ratio of weight (W) to height (H) squared; W/H2=kg/m2) of between 18.0 and 27.0 for women.
• Subjects must be able to read and understand instructions, as well as provide a valid informed consent.

You may not qualify if:

• Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.
• Participants with clinically significant medical disorders.
• Women who are pregnant as determined by laboratory testing for serum beta hCG.
• Women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures.
• Women with a mean BMI of outside the range 18.0-27.0.
• Subjects with peanut/peanut oil allergies will be excluded.
• Participants diagnosed with lactose intolerance will be excluded.
• Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

Alcohol and Drug Abuse Research Center at McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine; Progesterone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Nancy K Mello, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Alcohol and Drug Abuse Research Center & Professor of Psychology (Neuroscience), Harvard Medical School

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: September 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 17, 2024

Record last verified: 2013-01

Locations

US (1)