Opioid Compromise in Hypertension--Modulating Factors

Completed

• Conditions: Hypertension; Cardiovascular Diseases; Heart Diseases

• Registration Number: NCT00005434
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

To confirm the preliminary findings of age, race, and hypertension chronicity effects on opioid and cardiovascular responses to stress and to determine the opioid mechanisms mediating these effects using an opioid receptor blockade strategy.

Detailed Description

BACKGROUND:

Opioids exert depressor effects on cardiovascular responses through sympathetic nervous system inhibition. Research suggests that opioid inhibition of sympathetic activity may be compromised in hypertension. Preliminary studies by the Principal Investigator suggest that the nature of this compromise may be influenced by age and race. Additionally, literature suggests that hypertension chronicity may modulate opioid sympathoinhibitory actions. The receptor mechanisms mediating the observed modulating effects of age, race, and hypertension chronicity on opioidergic inhibition and regulation of blood pressure remained to be determined.

DESIGN NARRATIVE:

Two double-blind, placebo-controlled cross-over studies were conducted to evaluate the effects of naltrexone hydrochloride, an oral opiate antagonist, on adrenergically-mediated cardiovascular responses in older and younger, Black and White normotensives and hypertensives with varying lengths of hypertension duration. Cardiovascular and opioid responses were measured in response to a stressor combined with either placebo or naltrexone pretreatment. Results from these studies assisted in (a) elucidating opioidergic mechanisms underlying the increased rates of hypertension morbidity and mortality among Blacks and the elderly, and (b) ultimately optimized the design of pharmacological interventions for the prevention and treatment of hypertension.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Timeline

• Study Start: 1992-04
• Study Completion: 1997-03
• Status Verified: 2000-05
• Study First Submitted: 2000-05-25
• Study First Submitted QC: 2000-05-25
• Study First Posted: 2000-05-26
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified