Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00269269 |
| Other study ID # |
348 |
| Secondary ID |
R01HL073495 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
December 21, 2005 |
| Last updated |
February 17, 2016 |
| Start date |
September 2002 |
| Est. completion date |
July 2007 |
Study information
| Verified date |
January 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
To compare the unconditioned and conditioned effects of placebo capsules in the treatment of
patients with borderline hypertension (BH).
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 140/90 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.
