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Conditioned Pharmacotherapeutic Effects in Hypertension

Conditioned Pharmacotherapeutic Effects in Hypertension

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02056626
Enrollment
44
Registered
2014-02-06
Start date
2011-03-31
Completion date
2018-12-31
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension

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.

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.

Interventions

DRUGcarvedilol

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean Systolic Blood Pressureday 0

Countries

United States

Participant flow

Participants by arm

ArmCount
Partial Reinforcement
partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol
13
Controlled Dosing, Daily
controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol
13
Controlled Dosing, Every Other Day
controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol
4
Standard Therapy
standard therapy, 25 mg twice daily (15 days) carvedilol
14
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall Studypatient did not follow directions3100

Baseline characteristics

CharacteristicControlled Dosing, DailyPartial ReinforcementControlled Dosing, Every Other DayStandard TherapyTotal
Age, Continuous52.62 years
STANDARD_DEVIATION 12.14
44.62 years
STANDARD_DEVIATION 10.23
58.00 years
STANDARD_DEVIATION 6.88
56.21 years
STANDARD_DEVIATION 5.7
51.89 years
STANDARD_DEVIATION 10.45
Mean systolic blood pressure152.64 mmHg
STANDARD_DEVIATION 8.95
151.59 mmHg
STANDARD_DEVIATION 7.22
155.42 mmHg
STANDARD_DEVIATION 9.62
151.88 mmHg
STANDARD_DEVIATION 8.19
152.34 mmHg
STANDARD_DEVIATION 8.05
Number of participants taking other antihypertensives2 Participants5 Participants1 Participants2 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants5 Participants1 Participants2 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants1 Participants0 Participants5 Participants
Race (NIH/OMB)
White
10 Participants5 Participants2 Participants12 Participants29 Participants
Region of Enrollment
United States
13 participants13 participants4 participants14 participants44 participants
Sex: Female, Male
Female
6 Participants8 Participants1 Participants6 Participants21 Participants
Sex: Female, Male
Male
7 Participants5 Participants3 Participants8 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 130 / 40 / 14
other
Total, other adverse events
0 / 130 / 130 / 40 / 14
serious
Total, serious adverse events
0 / 130 / 130 / 40 / 14

Outcome results

Primary

Mean Systolic Blood Pressure

Time frame: day 0

ArmMeasureValue (MEAN)Dispersion
Partial ReinforcementMean Systolic Blood Pressure151.59 mmHgStandard Deviation 1.92
Controlled Dosing, DailyMean Systolic Blood Pressure152.64 mmHgStandard Deviation 2.38
Controlled Dosing, Every Other DayMean Systolic Blood Pressure155.42 mmHgStandard Deviation 4.17
Standard TherapyMean Systolic Blood Pressure151.74 mmHgStandard Deviation 2.05
Primary

Mean Systolic Blood Pressure

Time frame: day 14

ArmMeasureValue (MEAN)Dispersion
Partial ReinforcementMean Systolic Blood Pressure133.64 mmHgStandard Deviation 2.58
Controlled Dosing, DailyMean Systolic Blood Pressure132.92 mmHgStandard Deviation 3.2
Controlled Dosing, Every Other DayMean Systolic Blood Pressure133.12 mmHgStandard Deviation 3.2
Standard TherapyMean Systolic Blood Pressure135.00 mmHgStandard Deviation 2.21
Primary

Mean Systolic Blood Pressure

Time frame: day 30

ArmMeasureValue (MEAN)Dispersion
Partial ReinforcementMean Systolic Blood Pressure138.90 mmHgStandard Deviation 2.11
Controlled Dosing, DailyMean Systolic Blood Pressure136.38 mmHgStandard Deviation 3.34
Controlled Dosing, Every Other DayMean Systolic Blood Pressure139.27 mmHgStandard Deviation 0.64
Standard TherapyMean Systolic Blood Pressure134.94 mmHgStandard Deviation 2.71

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026