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. 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 when active drug is withdrawn and replaced by conditioned stimuli alone, resistance to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.

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