National Center for Complementary and Alternative Medicine (NCCAM)

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NCCAM High Priority Topics for Preliminary Clinical Studies for Large Interventional Trials of CAM (R34) PAR-10-163

October 2011

Since its establishment as a Center at the National Institutes of Health, the National Center for Complementary and Alternative Medicine (NCCAM) has provided research support for a broad spectrum of complementary and alternative medicine (CAM) modalities, with the goal of developing foundational evidence that would form the basis of further research. This strategy has facilitated a stream of meritorious investigator-initiated projects in diverse topics relevant to NCCAM's mission. As NCCAM's clinical research portfolio matures, we are identifying targeted areas of investigation for the CAM clinical research program.

Before large clinical trials are undertaken for any intervention, it is important that the necessary clinical studies are conducted to justify the appropriate patient population, optimize the intervention strategy, and identify the appropriate outcome measures. These issues are as important for CAM as for any area of medical research. This funding opportunity (PAR-10-163) is appropriate when there is a need for additional clinical studies before a larger clinical study can be designed and conducted.

While there are many areas of research with scientific promise and potential, NCCAM is currently accepting applications with an emphasis on the following list of high priority topics for CAM clinical research (PAR-10-163). Investigators interested in pursuing other areas of research should consult the other funding opportunities available (nccam.nih.gov/grants/).

Requests for permission to apply for PAR-10-163 will only be considered if the topic of research is in one of the priority areas below:

  1. Probiotics (food, dietary supplement or biotherapeutic form). Validate biomarkers, determine safety, or determine appropriate dosing and timing of probiotics for the following indications (must be in the list below):
    1. Gut barrier function in infants and children; the research may lead to larger clinical studies of necrotizing enterocolitis, colic, and irritable bowel syndrome
    2. Anti-infective effects in humans to treat or prevent antibiotic-induced diarrhea and enhance influenza vaccine activity
    3. Metabolic activity in individuals with obesity or metabolic syndrome
    4. Non-oral anti-inflammatory effects in atopic dermatitis or bacterial vaginosis
  2. Botanicals as adjunctive or alternative to pharmacological management of conditions such as chronic pain or functional pain syndromes (must be in the list below):
    1. Comparing the bioavailability, pharmacokinetics, and/or pharmacodynamics of various formulations of turmeric/curcumin (Curcuma longa) for musculoskeletal pain
    2. Determining the effects of various formulations of turmeric/curcumin (Curcuma longa) on biological markers of inflammatory bowel disorders
    3. Dosing studies and/or validation of appropriate biological signature of devil's claw (Harpagophytum procumbens) for musculoskeletal pain
    4. Dosing studies and/or validation of appropriate biological signature of butterbur (Petasites hybridus) for migraines
  3. Natural products in areas of high scientific promise (must be in the list below):
    1. Determining the effects of various formulations and various doses of vitamin E and/or validation studies of appropriate biological signature(s) of vitamin E for the treatment of non-alcoholic steatohepatitis or non-alcoholic fatty liver disease
  4. Mind and body interventions
    1. Mindfulness/meditation/yoga/tai chi/hypnosis (must be in the list below):
      1. Development and validation of treatment protocols that utilize mind-body approaches for the following indications: management of post-traumatic stress disorder, weight loss and weight loss maintenance, or chronic pain syndromes; including methods to measure treatment fidelity, as well as short-term and long-term adherence
      2. Validation of long- and short-term markers of the beneficial effects of mindfulness interventions
      3. Optimization of yoga, hypnosis, Mindfulness Based Stress Reduction (MBSR) or mindfulness cognitive behavior therapy(CBT) protocols for the treatment of sleep disturbance
    2. Manual therapies (must be in the list below):
      1. Identification and validation of biomarkers associated with reduction in pain or functional improvement in response to spinal manipulation or massage; and/or assessment of their dose responsiveness in patients with well-defined back pain
      2. Validation of a sham control for spinal manipulation or massage for treatment of chronic low-back pain and/or neck pain
      3. Assessment of clinical prediction rules for the response to spinal manipulation
      4. Assessment of the acceptability, adherence, and/or feasibility of CAM approaches that have previously demonstrated benefit for adults with low-back pain in new populations (youth, elderly, or specific ethnic or racial groups that were not represented in previous studies)
    3. Acupuncture (must be in the list below):
      1. Creating standardized (or semi-standardized) acupuncture treatment protocols and determining suitable control conditions or sham procedures to be used in future clinical trials of acupuncture for osteoarthritis, back and neck pain, chronic headache, and shoulder pain
  5. Complex complementary or integrative medicine approaches that have a strong justification for the need for larger clinical trials to study their impact on health behaviors (i.e., healthy eating, physical activity, stress reduction, adequate sleep, smoking cessation, medication adherence, and weight loss and maintenance):
    1. Developing well-characterized standardized protocols or algorithms of complex complementary or integrative medicine (e.g., naturopathic medicine, Ayurvedic medicine, traditional Chinese medicine and integrative medicine) approaches to improve health behaviors