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Conditioned Pharmacotherapeutic Effects in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056626
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : June 13, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
John Bisognano, University of Rochester

Brief Summary:
The proposed research is designed to determine if the application of classical conditioning operations could influence the clinical effects of a regimen of antihypertensive drug therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects, patients can be effectively treated with smaller cumulative amounts of drug.

Condition or disease Intervention/treatment Phase
Hypertension Drug: carvedilol Phase 4

Detailed Description:

The proposed research is designed to determine if the application of classical conditioning operations could influence the clinical effects of a regimen of antihypertensive drug therapy. In a double-blind, randomized, parallel-controlled clinical trial, It will be determined if, capitalizing on conditioned pharmacotherapeutic effects, patients can be effectively treated with smaller cumulative amounts of drug. To this end, some hypertensive patients will be treated on a partial rather than a continuous schedule of pharmacologic reinforcement. These patients will be compared to: (a) patients who continue to be treated under a standard regimen of pharmacotherapy at an effective dose of drug, and (b) patients who receive the same (reduced) cumulative amount of medication on a continuous schedule of reinforcement as that received by experimental patients treated under a partial schedule of reinforcement, and (c) patients who receive the same dose and frequency of carvedilol as the Partial Reinforcement Group but receive no intervening conditioned stimuli.

It is possible that a non-continuous schedule of pharmacologic reinforcement (and the concomitant reduced amount of active drug) will exert effects that are indistinguishable from a continuous (standard) regimen of pharmacotherapy (a higher cumulative amount of drug). That outcome or comparison, however, is not critical for evaluating the role of conditioning in the pharmacotherapy of hypertension. Specifically, we will test the hypotheses that:

  1. patients treated under a partial schedule of antihypertensive medication will show a greater amelioration of symptoms than that achieved by patients treated with that same (reduced) amount of drug administered under a continuous schedule of reinforcement;

    Conditions permitting, we will also test the predictions that:

  2. irrespective of initial treatment regimen, relapse will occur more quickly following withdrawal of active medication in patients who do not continue to receive conditioned stimuli (placebo) than in patients who continue to receive conditioned stimuli; and
  3. when active drug is withdrawn and replaced by conditioned stimuli alone, resistance to extinction will be greater (i.e., rate of relapse will be less) among patients treated under a partial schedule of reinforcement than patients treated with the same amount of drug administered under a continuous schedule of reinforcement (the partial reinforcement effect).

Positive results would transform the study and practice of pharmacotherapy with respect to placebo effects by providing a new model within which to design treatment protocols for patients with chronic diseases that capitalizes on conditioned pharmacotherapeutic responses. The model, from which testable hypotheses can be derived, also provides a new framework for research on placebo effects and the mechanisms underlying such phenomena.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Conditioned Pharmacotherapeutic Effects in Hypertension
Study Start Date : March 2011
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Carvedilol

Arm Intervention/treatment
Active Comparator: arm 2
partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)
Drug: carvedilol
Active Comparator: arm 3
controlled dosing schedule 6.25 mg twice daily (15 days)
Drug: carvedilol
Active Comparator: arm 4
controlled dosing schedule 6.25 mg twice daily, every other day (15 days)
Drug: carvedilol
Active Comparator: arm 1
standard therapy, 25 mg twice daily (15 days)
Drug: carvedilol



Primary Outcome Measures :
  1. Mean Systolic Blood Pressure [ Time Frame: day 0 ]
  2. Mean Systolic Blood Pressure [ Time Frame: day 14 ]
  3. Mean Systolic Blood Pressure [ Time Frame: day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systolic blood pressure between 140-160 mmHG
  • between 18-80 years old

Exclusion Criteria:

  • abnormal renal function
  • currently pregnant, or trying to become pregnant
  • being treated with a beta-blocker
  • use of illicit drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056626


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: John D. Bisognano, M.D., Ph.D. University of Rochester
  Study Documents (Full-Text)

Documents provided by John Bisognano, University of Rochester:
Informed Consent Form  [PDF] March 26, 2015

Publications:
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Responsible Party: John Bisognano, M.D., Ph.D, University of Rochester
ClinicalTrials.gov Identifier: NCT02056626    
Other Study ID Numbers: 5R01HL105520 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2014    Key Record Dates
Results First Posted: June 13, 2019
Last Update Posted: July 9, 2019
Last Verified: June 2019
Keywords provided by John Bisognano, University of Rochester:
hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists