NCT00029627

Brief Summary

The purpose of this study is to investigate the role of brain receptors called alpha2-adrenoreceptors in regulating the sympathetic nervous system, which maintains the supply of blood and fuel to the body's organs in times of stress, fear, anger, or exercise. Alpha(2)-adrenergic receptors (alpha(2)-AR) play a role in a variety of physiological functions. There are three subtypes of alpha(2)-ARs, and their differences are unknown. This study will examine the functional roles of these three subtypes by comparing the behavioral, biochemical, psychophysiological, and autonomic function effects of the alpha(2)-AR drugs clonidine and yohimbine. Participants in this study will undergo a physical examination, electrocardiogram (ECG), and blood, urine, and saliva tests. Women will have hormone tests to determine the time of their last period and the time of their next ovulation. Participants will undergo neuropsychological testing and other procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2004

First QC Date

January 16, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

Alpha2-AdrenoreceptorsPolymorphismsChallenge StudyYohimbineClonidineSubtypesNormal ControlHVHealthy Volunteer

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects with a negative first-degree family history of psychiatric disorders as determined by the Family Interview of Genetic Studies are eligible.
  • Subjects must be willing to participate in a challenge study.
  • Subjects must be in good physical health.
  • Subjects must have the absence of any Axis I and Axis II DSM-IV diagnosis.
  • Subjects will be excluded if they have evidence for an axis I psychiatric disorder or the presence of an axis II personality disorder.
  • Smokers are ineligible to participate.
  • Subjects with recent life stressors (3 months) or chronic life stressors (1 year) will be ineligible.
  • Subjects must be between the ages of 18 and 50.
  • Subjects must meet criteria for one of 6 genotypically defined subgroups.
  • Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 6 months prior to the challenge studies.

You may not qualify if:

  • Subjects will be excluded if they have medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders.
  • Subjects must not have a history of drug (including BZDs) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence.
  • Subjects with current or previous regular use (greater than 4 weeks) of BZDs and excessive use of alcohol (greater than 8 ounces/week for men and greater than 6 ounces/week for women) in the past or present are ineligible to participate.
  • Women who are currently pregnant or breastfeeding are not eligible.
  • Subjects who cannot hear a 40 dB(HL) pure tone in the 1000- to 4000 Hz span (Welsh Allen audioscope) will be excluded from studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Eisenhofer G, Esler MD, Meredith IT, Dart A, Cannon RO 3rd, Quyyumi AA, Lambert G, Chin J, Jennings GL, Goldstein DS. Sympathetic nervous function in human heart as assessed by cardiac spillovers of dihydroxyphenylglycol and norepinephrine. Circulation. 1992 May;85(5):1775-85. doi: 10.1161/01.cir.85.5.1775.

    PMID: 1572033BACKGROUND
  • O'Dowd BF, Lefkowitz RJ, Caron MG. Structure of the adrenergic and related receptors. Annu Rev Neurosci. 1989;12:67-83. doi: 10.1146/annurev.ne.12.030189.000435.

    PMID: 2648960BACKGROUND
  • Venter JC, Fraser CM, Kerlavage AR, Buck MA. Molecular biology of adrenergic and muscarinic cholinergic receptors. A perspective. Biochem Pharmacol. 1989 Apr 15;38(8):1197-208. doi: 10.1016/0006-2952(89)90325-0. No abstract available.

    PMID: 2650684BACKGROUND

MeSH Terms

Interventions

Yohimbine

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 16, 2002

First Posted

January 17, 2002

Study Start

January 1, 2002

Study Completion

December 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-12

Locations