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Conditioned Pharmacotherapeutic Effects in Hypertension

This study is currently recruiting participants.
Verified May 2017 by John Bisognano, University of Rochester
Sponsor:
ClinicalTrials.gov Identifier:
NCT02056626
First Posted: February 6, 2014
Last Update Posted: May 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
John Bisognano, University of Rochester
February 4, 2014
February 6, 2014
May 9, 2017
March 2011
April 2018   (Final data collection date for primary outcome measure)
systolic blood pressure [ Time Frame: up to 8 weeks ]
Same as current
Complete list of historical versions of study NCT02056626 on ClinicalTrials.gov Archive Site
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Conditioned Pharmacotherapeutic Effects in Hypertension
Conditioned Pharmacotherapeutic Effects in Hypertension
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hypertension
Drug: carvedilol
  • Active Comparator: arm 2
    partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)
    Intervention: Drug: carvedilol
  • Active Comparator: arm 3
    controlled dosing schedule 6.25 mg twice daily (15 days)
    Intervention: Drug: carvedilol
  • Active Comparator: arm 4
    controlled dosing schedule 6.25 mg twice daily, every other day (15 days)
    Intervention: Drug: carvedilol
  • Active Comparator: arm 1
    standard therapy, 25 mg twice daily (15 days)
    Intervention: Drug: carvedilol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
121
October 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: John D Bisognano, M.D., Ph.D 585-341-7700
United States
 
 
NCT02056626
5R01HL105520( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
John Bisognano, University of Rochester
University of Rochester
Not Provided
Principal Investigator: John D. Bisognano, M.D., Ph.D. University of Rochester
University of Rochester
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP