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Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease (Cannabis-SCD)

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabis

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2013
Last Updated
August 5, 2020
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01771731
Brief Title
Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease
Acronym
Cannabis-SCD
Official Title
Cannabinoid-Based Therapy and Approaches to Quantify Pain in Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
May 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota

4. Oversight

5. Study Description

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: Inhaled cannabis will significantly reduce chronic pain in patients with SCD. Inhaled cannabis will significantly alter the short-term side effects experienced by patients who take opioids for SCD. Inhaled cannabis will significantly alter markers of inflammation and disease progression in patients with SCD compared to placebo.
Detailed Description
This is a proof-of-principle investigation of the safety and potential effectiveness of inhaled vaporized cannabis when added to a stable analgesic regimen in sickle cell disease (SCD) patients with chronic pain. The study will be comprised of two 5-day intervention periods in the inpatient setting (the Clinical Research Center at SFGH), with completion of a 5-day daily pain diary prior to admission to establish an outpatient baseline. Participants will be randomly assigned, in double-blind fashion, to treatment with (A) vaporized cannabis with an approximately 1:1 ration of delta-9-tetrahydrocannabinol:cannabidiol or (B) vaporized placebo. Those who receive treatment A during the first admission will receive treatment B in the second, and those who receive treatment B during the first admission will receive treatment A in the second. The two admissions will be spaced at least 14 days apart. On Day 1 of each admission, subjects will provide blood samples for baseline markers of inflammation and SCD disease progression. They will undergo assessments of pain, mood, and quality of life. At 12 pm on Day 1, they will inhale vaporized study agent (equivalent to 1 cannabis/placebo cigarette) using the Volcano® vaporizer; on Days 2-4 they will inhale study agent at 8 am, 2 pm, and 8 pm, and they will inhale their final dose on Day 5 at 8 am. Subjects will continue their pre-study analgesic regimen while in the study. If additional analgesia is required, supplemental therapy will be administered and the dose recorded. Pain measurements by visual analogue scale will be obtained every 2 hours while subjects are awake. On Day 5 a second set of blood samples for inflammation markers and disease progression will be obtained, and subjects will again complete pain, mood, and quality of life assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
marijuana
Primary Outcome Measure Information:
Title
Pain Rating Using Visual Analog Scale at Day 1 and Day 5
Description
Visual analog scale (VAS) used to assess pain. The scale range is 0-100, lower score means lower pain, higher score means higher pain.
Time Frame
Day 1 and Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald I Abrams, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32678452
Citation
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.
Results Reference
result
PubMed Identifier
32977351
Citation
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.
Results Reference
derived

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Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease

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