Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease

NCT01771731 | Completed Phase 1 Results

• 2 other identifiers: U54HL117664-016610
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Pain Rating Using Visual Analog Scale at Day 1 and Day 5

  Visual analog scale (VAS) used to assess pain. The scale range is 0-100, lower score means lower pain, higher score means higher pain.

  Day 1 and Day 5

Study Arms (2)

Cannabis

EXPERIMENTAL

Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.

Drug: Cannabis

Placebo

PLACEBO COMPARATOR

Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.

Drug: Cannabis

Interventions

Cannabis DRUG

Also known as: marijuana

Cannabis; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Minnesota: collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (2)

• Abrams DI, Couey P, Dixit N, Sagi V, Hagar W, Vichinsky E, Kelly ME, Connett JE, Gupta K. Effect of Inhaled Cannabis for Pain in Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jul 1;3(7):e2010874. doi: 10.1001/jamanetworkopen.2020.10874.

  PMID: 32678452 RESULT

• Oniyangi O, Cohall DH. Phytomedicines (medicines derived from plants) for sickle cell disease. Cochrane Database Syst Rev. 2020 Sep 25;9(9):CD004448. doi: 10.1002/14651858.CD004448.pub7.

  PMID: 32977351 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Donald I. Abrams, MD
• Organization: University of California San Francisco

Donald.Abrams@ucsf.edu

415-476-4082

Study Officials

• Donald I Abrams, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 18, 2013
• Study Start: August 1, 2014
• Primary Completion: May 12, 2017
• Study Completion: May 19, 2017
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

US (1)