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Investigation of Cannabis for Chronic Pain and Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02683018
Recruitment Status : Withdrawn (funding)
First Posted : February 17, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Martinez, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE February 11, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 28, 2019
Estimated Study Start Date  ICMJE December 2050
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Change in pain ratings using the McGill Pain Questionnaire [ Time Frame: 4 weeks ]
    Participants will be asked to rate their pain over the 4 weeks of receiving active cannabis vs placebo.
  • Change in sickness-related impairment using the Sickness Impact Profile [ Time Frame: 4 weeks ]
    Participants will be asked to rate physical symptoms for the 4 weeks of the study.
  • changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument [ Time Frame: 4 weeks ]
    RAND-36 item medical outcomes survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
  • Changes in symptoms of pain using the 9 item Brief Pain Inventory [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02683018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ) [ Time Frame: 4 weeks ]
  • Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 4 weeks ]
  • Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5) [ Time Frame: 4 weeks ]
  • Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire [ Time Frame: 4 weeks ]
  • Changes in quality of life using the McGill Quality of Life Questionnaire [ Time Frame: 4 weeks ]
  • Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS) [ Time Frame: 4 weeks ]
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 4 weeks ]
  • Change in mood using the Hamilton Depression Rating Scale [ Time Frame: 4 weeks ]
  • Change in mood Hamilton Anxiety Rating Scale [ Time Frame: 4 weeks ]
  • Change in mood using the Montgomery-Asberg Depression Rating Scale [ Time Frame: 4 weeks ]
  • Change in mood and quality of life using the Columbia Suicide Severity Rating Scale [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Cannabis for Chronic Pain and Palliative Care
Official Title  ICMJE Investigation of Cannabis for Chronic Pain and Palliative Care
Brief Summary

The use of cannabis for severe medical conditions is being legalized in different states, increasing the mandate to make cannabis legal for medically ill patients. However, there is a lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of THC, is approved for nausea/vomiting in chemotherapy patients. These medications have been found to be effective for these disorders, but there remains an interest in studying cannabis, partly due to the numerous cannabinoids contained within the cannabis plant. Among these is cannabidiol, which does not produce subjective effects, but has been shown to have potent anti-inflammatory effects. In addition, there is data indicating that cannabidiol may be effective for neuropathic pain and nausea/vomiting.

The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as pain, nausea/vomiting, and quality of life in seriously ill participants. While there is data beginning to emerge that cannabis may have a beneficial effect on these symptoms, there are few placebo controlled, double-blind studies. Additionally, the administration of cannabis to medically ill patients may be limited by its subjective effects, such as anxiety, intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC (about 15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized that some of these effects can be avoid, while maximizing the therapeutic effects, if any.

Detailed Description

The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in medically ill participants seeking relief symptoms such as pain, nausea, and vomiting. Participants who meet criteria for severe conditions will be referred from their clinicians . Cannabis that has a high concentration of cannabidiol, which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC will be used. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.

The overall goal of this study is to compare active high cannabidiol (CBD)/ low (−)-trans-Δ9- tetrahydrocannabinol (THC) cannabis vs placebo cannabis in patients with serious medical disorders. Participants will be referred from clinicians and will come to the laboratory daily (3-5 times weekly) for cannabis (15.76% CBD; 3.11% Δ-9-THC) vs placebo (0.0% CBD/ 0.01% Δ-9-THC). The cannabis will be vaporized or smoked as a cannabis cigarette. The participants can choose which option they prefer. The cross-over design will be used where participants receive 2 weeks of active cannabis vs two weeks of placebo in counterbalanced order, with participants blinded to the condition. The outcome measures primarily include measures of pain, with secondary measures of mood, nausea/appetite, quality of life, and the both the potentially positive and negative subjective effects of cannabis (e.g., high, mellow, anxious, paranoid).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Smoked Cannabis High CBD/low THC
    Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session.
    Other Name: cannabis cigarettes (15.76% CBD; 3.11% THC)
  • Drug: Smoked Placebo Cannabis Low CBD/low THC
    Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session.
    Other Name: cannabis cigarettes (0.01% THC; 0.00% CBD)
Study Arms  ICMJE
  • Active Comparator: Smoked Cannabis High CBD/low THC
    Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 Smoked Cannabis High CBD/low THC cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session.
    Intervention: Drug: Smoked Cannabis High CBD/low THC
  • Placebo Comparator: Smoked Placebo Cannabis Low CBD/low THC
    Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session.
    Intervention: Drug: Smoked Placebo Cannabis Low CBD/low THC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2016)
70
Estimated Study Completion Date  ICMJE December 2050
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. One of the medical diagnoses (cancer, amyotrophic lateral sclerosis, Parkinson's disease, spinal cord injury, neuropathy, and phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, and neuropathic facial pain), with reports of pain (at least 3 on item 3 on the 9 item Brief Pain Inventory)that remains despite their current medical treatment.
  2. Age 21-60
  3. Able to give informed consent, and comply with study procedures
  4. Experience inhaling substances.

Exclusion Criteria:

  1. Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidality, or psychosis, that could be exacerbated by the administration of cannabis
  2. Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis.
  3. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant
  4. Current (weekly) use of cannabis
  5. Participants on supplemental oxygen
  6. Participants with a substance use disorder involving marijuana or opioids.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02683018
Other Study ID Numbers  ICMJE 7220
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diana Martinez, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Diana Martinez, MD New York Sate Psychiatric Institute/ Columbia University
PRS Account New York State Psychiatric Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP