Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease

• Status: Completed
• Trial end date: 2017-05-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Minnesota; University of Minnesota - Clinical and Translational Science Institute

Criteria

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.