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Investigation of Cannabis for Pain and Inflammation in Lung Cancer

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ClinicalTrials.gov Identifier: NCT02675842
Recruitment Status : Withdrawn (funding)
First Posted : February 5, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Martinez, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE Not Provided
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • Change in pain ratings using The McGill Pain Questionnaire [ Time Frame: 6 weeks ]
    Participants will be asked to rate their pain over the 6 weeks of receiving active cannabis vs placebo.
  • Change in sickness-related impairment using the Sickness Impact Profile Questionnaire [ Time Frame: 6 weeks ]
    Participants will be asked to rate physical symptoms for the 6 weeks of the study.
  • changes in physical and emotional well being using RAND 36 item medical outcomes survey [ Time Frame: 6 weeks ]
  • Changes in symptoms of pain using 9 item Brief Pain Inventory [ Time Frame: 6 weeks ]
  • Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire [ Time Frame: 6 weeks ]
  • changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom [ Time Frame: 6 weeks ]
  • Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • Assessment of subjective effects using VAS [ Time Frame: 6 weeks ]
    The visual analog scales (VAS) will be used to investigate the subjective effects while participants are in the laboratory.
  • change in eating measured using food diary [ Time Frame: weekly for 6 weeks ]
    Participants will be asked to complete a food diary during the 6 weeks and will be weighed weekly during the study.
  • Change in mood using the Hamilton Depression Rating Scale [ Time Frame: 6 weeks ]
    Hamilton Depression Rating Scale will be used to assess mood during the 6 weeks of the study.
  • Change in mood Hamilton Anxiety Rating Scale [ Time Frame: 6 weeks ]
    Hamilton Anxiety Rating Scale will be used to assess mood during the 6 weeks of the study.
  • Change in mood using the Montgomery-Asberg Depression Rating Scale [ Time Frame: 6 weeks ]
    The Montgomery-Asberg Depression Rating Scale will be used to assess the participants' mood throughout the six weeks of the study.
  • Change in mood and quality of life using the Columbia Suicide Severity Rating Scale [ Time Frame: 6 weeks ]
  • change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ) [ Time Frame: 6 weeks ]
  • Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 6 weeks ]
  • Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire [ Time Frame: 6 weeks ]
  • Change in opioid use using the Opioid use Questionnaire [ Time Frame: Daily for 6 weeks ]
    Participants will be asked to provide to the number of opioid medications taken. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.
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 Pain and Inflammation in Lung Cancer
Official Title  ICMJE Investigation of Cannabis for Pain and Inflammation in Lung Cancer
Brief Summary

Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis has been shown to greatly inhibit inflammation. The compound (-)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain. Cannabidiol is a component of cannabis that does not produce subjective or intoxicating effects, but also has prominent anti-inflammatory properties.

The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used , which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.

Detailed Description

Study Outline

Patients will be referred to the study from their physician, who will have the patients medically cleared for participation.

The patients will then undergo additional screening for the study. A study physician will review all study procedures with potential participants, including the potential side effects. Patients will be shown the facilities and informed of being monitored at all times.

Patients will be randomized using a randomization and assigned to one of two groups: cannabis (15.76% CBD; 3.11% Δ-9 -THC) vs "placebo" cannabis (0.0% CBD/ 0.01% Δ-9-THC).

Participants will visit the Marijuana Research Laboratory, 3-5 days a week over 6 weeks to be administered 1-2 cannabis cigarettes over the course of a 2-3 hour session. Two cannabis conditions will be tested: Placebo (0.01% THC; 0.00% CBD) and CBD:THC (15.76% CBD; 3.11% THC) provided by the National Institute on Drug Abuse.

Participants will undergo baseline measurements of mood, and physical symptoms and will then be given 2 NIDA (National Institute on Drug Abuse) cannabis cigarettes, which can be consumed as smoking or with a vaporizer in a ventilated room. After the 90 minutes of cannabis availability end, participants will be asked to remain in the laboratory for an additional 45 minutes to allow the effects of the cannabis to wear off.

Participants will undergo baseline measurements of mood, and physical symptoms and will then be given the equivalent of 2 NIDA cannabis cigarettes. Cardiovascular and subjective effects measures of mood, abuse liability and drug tolerability will be collected at baseline, at the end of the 90 minutes of cannabis availability and at the end of the session. Detailed measures of food intake (caloric content, macronutrient intake) will be recorded beginning immediately after cannabis administration and for the duration of the session. In addition to visual analog scales, participants will be asked to complete measures of mood and cannabis effects at screening, before, during and after the session. Participants will be assessed at the end of the session by an experienced clinician.

Opioid use: Participants will be asked to provide the number of opioid medications taken as follows: 1) at baseline (in the week prior to starting sessions); and 2) at each session, participants will be asked about opioid use since the previous session. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.

Food intake: Participants will be asked to complete a daily food diary for the duration of the study. Detailed measures of food intake (caloric content, macronutrient intake) will also be recorded during the cannabis sessions. Participants will also be weighed weekly.

PET (Positron Emission Tomography) scans: As part of their clinical care, patients receive a PET/CT scan using the radiotracer [18F]FDG with a low dose CT for attenuation correction and anatomic localization. This data will be requested from the PET center, with the participants consent, in order to assess the extent of esophagitis in the two groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Smoked Cannabis High CBD/low THC
    Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
  • Drug: Smoked Placebo Cannabis Low CBD/low THC
    Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
Study Arms  ICMJE
  • Active Comparator: Smoked Cannabis High CBD/low THC
    Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
    Intervention: Drug: Smoked Cannabis High CBD/low THC
  • Placebo Comparator: Smoked Placebo Cannabis Low CBD/low THC
    Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
    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: October 16, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2016)
30
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of Lung Cancer receiving RT.
  2. Age 21- 60
  3. Able to give informed consent, and comply with study procedures.
  4. History of previous experience with smoking or marijuana. On PFTs (Pulmonary Function Tests), participants must have an FEV1 (Forced Expiratory Volume in 1 second) of ≥ 1.2 liters/second or ≥ 50% predicted using the CDC reference value calculator.

Exclusion Criteria:

  1. Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, 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 history of substance use disorder other than nicotine, such as opiate disorder
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 NCT02675842
Other Study ID Numbers  ICMJE 7221
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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 Columbia University/NYSPI
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