Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cannabinoid-Based Therapy and Approaches to Quantify Pain in Sickle Cell Disease
Brief Summary: Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic pain in patients with sickle cell disease (SCD). As these patients will all be on chronic opioid analgesics, the investigators will also assess the possible synergistic affect between inhaled cannabis and opioids. The investigators will also assess the clinical safety of the concomitant use of cannabinoids and these opioids in patients with SCD by monitoring the short-term side effects associated with combined therapy. Finally, the investigators will evaluate the short-term effects of inhaled cannabis on markers of inflammation and disease progression in patients with SCD.

Hypotheses are as follows:

1. Inhaled cannabis will significantly reduce chronic pain in patients with SCD.
2. Inhaled cannabis will significantly alter the short-term side effects experienced by patients who take opioids for SCD.
3. Inhaled cannabis will significantly alter markers of inflammation and disease progression in patients with SCD compared to placebo.


Options:
A: Inclusion Criteria:

* Diagnosis of Hemoglobin (Hb) SS or Hb Sβ0 thalassemia by electrophoresis
* Age ≥18 years
* Hematocrit (Hct) ≥ 20% and Hb \> 6.0 g/dL
* Capacity to understand and sign informed consent and can adhere to the daily regimen of BSH

Exclusion Criteria:

* RBC transfusion or change in hydroxyurea dose during the 3 months prior to study entry
* Ongoing pregnancy
* Diabetes
* Renal insufficiency (BUN \>21 mg/dL and/or Creatinine \>1.4 mg/dL)
* History of allergy to sulfonamides
B: Inclusion Criteria:

* Majority fetal and sickle (FS or SF) hemoglobin pattern confirmed centrally by electrophoresis (screening may begin at 7 months of age)

Exclusion Criteria:

* Chronic transfusion therapy
* Cancer
* Less than 5th percentile (10th percentile for the pilot study) height, weight, or head circumference for age
* Severe developmental delay (e.g., cerebral palsy or other mental retardation, Grade III/IV intraventricular hemorrhage)
* Stroke with neurological deficit
* Surgical splenectomy
* Participating in other clinical intervention trials
* Probable or known diagnosis of Hemoglobin S-Hereditary Persistence of Fetal Hemoglobin
* Known hemoglobin S-beta plus thalassemia (hemoglobin A present)
* Any condition or chronic illness, which in the opinion of the principal investigator, makes participation unadvised or unsafe
* Inability or unwillingness to complete baseline (pre-enrollment) studies, including blood or urine specimen collection, liver-spleen scan, abdominal sonogram, neurological examination, neuropsychological testing, or transcranial Doppler ultrasound (interpretable study not required, but confirmed velocity greater than 200 cm/sec results in ineligibility)
* Previous or current treatment with hydroxyurea (HU) or another anti-sickling drug
* The following exclusion criteria are transient; patients can be re-evaluated for eligibility:

  1. Hemoglobin less than 6.0 gm/dL
  2. Reticulocyte count less than 80,000/cu mm if hemoglobin is less than 9 gm/dL
  3. Neutrophil count less than 2,000/cu mm
  4. Platelet count less than 130,000/cu mm
  5. Blood transfusion in the 2 months prior to study entry unless HbA is less than 10%
  6. ALT greater than twice the upper limit of normal
  7. Ferritin less than 10 ng/ml
  8. Serum creatinine greater than twice the upper limit of normal for age
  9. Bayley standardized mental score below 70
C: Inclusion Criteria:

* Sickle cell disease, including sickle cell anemia (SS), sickle-hemoglobin C disease (SC), and sickle beta thalassemia disease (Sb).
* Ongoing opioid analgesic therapy for chronic sickle cell disease-associated pain.
* Subjects must be on a stable dose of analgesic medication (opioid or other) for at least 2 weeks before enrollment.
* All men and women in this study must agree to use adequate birth control during this study. Acceptable barrier birth control methods are a male condom, female condom, diaphragm, or intra-uterine (IUD).
* All women of reproductive potential (who have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) must have a negative urine b-HCG pregnancy test performed before initiating the protocol-specified medication.
* Prior history of use of cannabis. Subjects must have smoked cannabis on at least 6 occasions in their lifetime prior to enrollment.
* Subjects will self-report abstaining from smoking or ingesting cannabis for one week prior to their enrollment into the study.
* Able to understand and follow the instructions of the investigator, including completing the pain intensity rating scales.
* Karnofsky Performance Scale \>60.
* Able and willing to provide informed consent.
* Able and willing to spend two separate periods of 5 days and 4 nights in the Clinical Research Center at SFGH.

Exclusion Criteria:

* Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, orthostatic mean blood pressure drop greater than 24 mmHg, severe chronic obstructive pulmonary disease.
* Evidence of clinically significant hepatic or renal dysfunction based on judgment of physician.
* Positive serum THC level on Day 1 of study.
* Active substance abuse (e.g., alcohol or injection drugs) as determined by urine toxicity screening.
* Neurologic dysfunction or psychiatric disorder severe enough to interfere with assessment of pain or sensory systems.
* Current use of smoked tobacco products.
* Women who are pregnant or breast-feeding may not take part in this study.
* Unable to read or speak English.
D: Inclusion Criteria:

1. over 5 year old
2. less t5han 50
3. diagnosed with homozygous sickle cell anemia by Hb electrophoresis

Exclusion Criteria:

1. patients received blood transfusion within the last three months or admitted to the hospital within 2 weeks because of Sickle cell anemia -related events or crisis.

Answer: C