Clinical trial NCT03978156: Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease
Official title: Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Sickle Cell Disease
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double blind, cross-over study of dronabinol compared to placebo
Primary purpose: TREATMENT

Brief summary: This study is designed to address the feasibility of a randomized, double masked, cross-over study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

Detailed description: The Primary Hypothesis is that such a study will be feasible as defined by subject adherence to study medication and study procedures and avoidance of other cannabinoid containing substances during the trial period as well as by ability to mask subjects and investigators to treatment assignment

Secondary hypotheses are:

Dronabinol will:

Reduce patient-reported pain interference Reduce patient-reported pain scores and change patient-reported pain quality. Reduce use of opioid pain medications. Improve patient-reported stiffness, nausea and vomiting, sleep, mood, anxiety, and social functioning.

Reduce markers of inflammation.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥18 years, able to understand and sign the informed consent form
* Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
* Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
* Willing to abstain from marijuana, medical and illicit, during study weeks 1 through 6.
* For patients currently receiving hydroxyurea and/or L-glutamine, on a stable dose(s) for at least 3 months
* For patients currently on a chronic red blood cell transfusion program, on such a program for at least 3 months

Exclusion Criteria:

* Known intolerance to dronabinol, sesame oil, or marijuana
* Patients with a diagnosis or medical history of any psychiatric disorder with psychosis
* Presence of any concomitant medical condition, or use of concomitant medication, that, in the Investigator's opinion, may place the subject at increased risk of side effects of dronabinol.
* Pregnant or nursing women
* If a woman capable of becoming pregnant, unwilling to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception or vaginal ring, medroxyprogesterone, contraceptive implants, intrauterine device, or patch, surgical sterilization, total abstinence. We have not included a similar restriction for men as the current FDA approval includes no such restriction.

Primary outcomes:
measure: Feasibility will be defined by ability to mask patients and investigators to treatment assignment and adherence
timeFrame: 1 year
measure: Adherence
timeFrame: 1 year
measure: Avoidance
timeFrame: 7 weeks
measure: Adherence to other study proceedures
timeFrame: 7 weeks
Secondary outcomes:
measure: Patient reported 7-day pain interference
timeFrame: 7 days
measure: Patient Pain Severity
timeFrame: end of 2nd week
measure: Patient Pain Unpleasantness
timeFrame: end of 2nd week
measure: PROMIS (Patient Reported Outcomes Measurement Information System) Nociceptive Pain Severity
timeFrame: end of 2nd week
measure: PROMIS Neuropathic Pain Severity
timeFrame: end of 2nd week
measure: PROMIS Gastrointestinal Nausea short form measure
timeFrame: end of 2nd week
measure: PROMIS short form for emotional distress anxiety 8a.
timeFrame: end of 2nd week
measure: Adult Sickle Cell Quality (ASCQ)-Me short form measures of emotional impact
timeFrame: end of 2nd week
measure: Adult Sickle Cell Quality (ASCQ)-Me short form measure of sleep impact
timeFrame: end of 2nd week
measure: Adult Sickle Cell Quality (ASCQ)-Me short form measure of stiffness impact
timeFrame: end of 2nd week
measure: Adult Sickle Cell Quality (ASCQ)-Me short form measure of social functioning impact
timeFrame: end of 2nd week
measure: Opioid Utilization
timeFrame: end of 2nd week
measure: Markers of Inflammation Concentration of white blood cell count differential
timeFrame: end of 2nd week
measure: Markers of Inflammation C reactive protein
timeFrame: end of 2nd week
measure: Markers of Inflammation serum tryptase
timeFrame: end of 2nd week
measure: Serum pro-inflammatory cytokines
timeFrame: end of 2nd week
measure: Serum measure of Substance P
timeFrame: end of 2nd week
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital Smilow Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine Oncology Section
name: Susanna Curtis, MD
role: PRINCIPAL_INVESTIGATOR
References: