Conditioned Pharmacotherapeutic Effects in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): carvedilol
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hypertension