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

NCT01589055 | Withdrawn

• 1 other identifier: 2005-p-001057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effects of nicotine on hormones and mood states

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

  From baseline to study completion (approximately 4 months for males and 8 months for females)

Study Arms (3)

Male Smokers

ACTIVE COMPARATOR

Drug: Intravenous Nicotine

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

ACTIVE COMPARATOR

Drug: Intravenous Nicotine

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

ACTIVE COMPARATOR

Drug: Intravenous Nicotine

Interventions

Intravenous Nicotine DRUG

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.

Also known as: IV Nicotine

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

Eligibility Criteria

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

You may qualify if:

• Men and 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 (305.10) will be eligible for participation.
• No evidence of clinically significant disease based upon complete medical history and physical examination by Dr. Arthur Siegel (Chief of Internal Medicine, McLean Hospital).
• 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 test, 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 ≥ 39% for males and ≥ 35% for females.
• Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study day.
• Normal ECG.
• Subjects must be able to read and understand instructions, as well as provide a valid informed consent.

You may not qualify if:

• Women and men with any lifetime DSM-IV Axis I disorder other than nicotine abuse or dependence will be excluded.
• Women who are pregnant will be excluded.
• Women who use hormonal contraceptive medications will not be accepted for participation because this would confound the hormonal measures.
• Men and women with clinically significant medical disorders will be excluded.
• Obese and underweight subjects will be excluded. A mean Body Mass Index (ratio of weight (W) to height (H) squared; W/H2=kg/m2) will be calculated. Women with a mean Body Mass Index (BMI) of between 18.0-27.0 and men with a BMI between 21.4-29.0 will be accepted.
• Treatment seeking subjects 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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nancy K M, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• 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: April 1, 2005
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 17, 2024

Record last verified: 2013-03

Locations

US (1)