Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects

NCT01636336 | Suspended

• 1 other identifier: 2009-p-001665
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the HPA axis in the abuse-related effects of nicotine.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• Effects of Progesterone on Nicotine-Induced Changes on the hypothalamic-pituitary adrenal (HPA) axis

  The investigators are examining the effects of progesterone on smoked nicotine induced changes in serum/plasma hormone levels.

  From baseline to study completion (approximately 8 months for females)

• Effects of Nicotine on the hypothalamic-pituitary-gonadal (HPG) axis

  The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.

  From baseline to study completion (approximately 8 months for females)

Secondary Outcomes (2)

• Effects of Nicotine on a Visual Analog Scale of Mood States

  From baseline to study completion (approximately 8 months for females)

• Effects of Nicotine on Cardiovascular Measures

  From baseline to study completion (approximately 8 months for females)

Study Arms (2)

Female Smokers (Mid-Luteal Phase; cycle days 18-22)

ACTIVE COMPARATOR

Other: Nicotine; Other: Progesterone

Female Smokers (Early Follicular Phase; cycle days 4-8)

ACTIVE COMPARATOR

Other: Nicotine; Other: Progesterone

Interventions

Nicotine OTHER

Two doses of nicotine will be utilized in the study: a commercially available, high-yield nicotine cigarette (Marlboro Red; Phillip Morris brand) and a denicotinized cigarette (Murty Pharmaceuticals Inc., Lexington, KY). The high dose cigarettes contain 15.48 mg of nicotine and 16 mg of tar based on analysis by the Massachusetts Department of Public Health (MDPH, 1998). The low nicotine cigarettes contain 1.1 mg of nicotine and deliver 0.1 mg of nicotine and 2.8 mg of tar based on analyses provided by the manufacturer.

Female Smokers (Early Follicular Phase; cycle days 4-8); Female Smokers (Mid-Luteal Phase; cycle days 18-22)

Progesterone OTHER

Prometrium capsules containing 200 mg of micronized progesterone will be obtained from Solvay Pharmaceuticals, Inc. (210 Main Street West, Baudette, MN, 56623, phone (218) 634-3500, fax (218) 634-3540).

Female Smokers (Early Follicular Phase; cycle days 4-8); Female Smokers (Mid-Luteal Phase; cycle days 18-22)

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.
• Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.
• Subjects with peanut/peanut oil allergies will be excluded.
• Participants diagnosed with lactose intolerance will be excluded.

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: SINGLE
• Who Masked: PARTICIPANT
• 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: June 21, 2012
• First Posted: July 10, 2012
• Study Start: September 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)