Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269269
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2005-12-21
Brief Title:
Conditioned Placebo Effects and Treatment of Hypertension
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension BH
Detailed Description:
DESIGN NARRATIVE
This study will compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension BH The use of placebos is routine in trials of antihypertensive medication but the placebo is nearly always given before the active drug and most studies have relied on traditional clinic measurement of blood pressure BP However ambulatory BP monitoring ABPM is the gold standard for evaluating the effectiveness of any antihypertensive treatment and placebo effects on ABP have mostly been negligible However there is also evidence that when a placebo is given after the active drug there may be a more profound effect A long series of both animal and human studies by the co-principal investigator Dr Ader have shown that such learned or classically conditioned placebo effects may have genuinely therapeutic effects One such study which will provide the basis for the current study found that placebo given after the active drug lowered home BP but ABP was not evaluated The current study will extend the previous one and will be performed in Community Health Centers in a culturally diverse economically disadvantaged population 120 patients with untreated BH will have their BPs monitored by clinic home and ABP recording After a 4-week run-in period of telephone-linked home monitoring continued throughout the study they will be randomized to 3 groups no drug active drug a beta blocker-diuretic combination or matching placebo This will enable evaluation of the unconditioned placebo effect For the next 4 weeks all 3 groups will receive active drug ABPM and clinic BP will be measured at the end of each period For the final period patients in each group will be randomized to no drug or placebo ABPM and clinic BP will be measured after 2 weeks but home BP will continue until BP returns to 14090 mmHg It is hypothesized that the conditioned placebo effect will result in a delayed return of BP to pretreatment levels and the inclusion of the No Drug group will distinguish this from the effects of drug washout To promote and assess compliance with the medications electronic containers MEMscaps will be used The demonstration of a conditioned placebo effect that produces a sustained reduction of BP could result in more economical treatment with fewer side effects
This study will compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension BH The use of placebos is routine in trials of antihypertensive medication but the placebo is nearly always given before the active drug and most studies have relied on traditional clinic measurement of blood pressure BP However ambulatory BP monitoring ABPM is the gold standard for evaluating the effectiveness of any antihypertensive treatment and placebo effects on ABP have mostly been negligible However there is also evidence that when a placebo is given after the active drug there may be a more profound effect A long series of both animal and human studies by the co-principal investigator Dr Ader have shown that such learned or classically conditioned placebo effects may have genuinely therapeutic effects One such study which will provide the basis for the current study found that placebo given after the active drug lowered home BP but ABP was not evaluated The current study will extend the previous one and will be performed in Community Health Centers in a culturally diverse economically disadvantaged population 120 patients with untreated BH will have their BPs monitored by clinic home and ABP recording After a 4-week run-in period of telephone-linked home monitoring continued throughout the study they will be randomized to 3 groups no drug active drug a beta blocker-diuretic combination or matching placebo This will enable evaluation of the unconditioned placebo effect For the next 4 weeks all 3 groups will receive active drug ABPM and clinic BP will be measured at the end of each period For the final period patients in each group will be randomized to no drug or placebo ABPM and clinic BP will be measured after 2 weeks but home BP will continue until BP returns to 14090 mmHg It is hypothesized that the conditioned placebo effect will result in a delayed return of BP to pretreatment levels and the inclusion of the No Drug group will distinguish this from the effects of drug washout To promote and assess compliance with the medications electronic containers MEMscaps will be used The demonstration of a conditioned placebo effect that produces a sustained reduction of BP could result in more economical treatment with fewer side effects
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL073495 | NIH | None | httpsreporternihgovquickSearchR01HL073495 |