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Primary Outcome Measures:

  • Change in pain ratings using The McGill Pain Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Changes in symptoms of pain using 9 item Brief Pain Inventory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:

  • Assessment of subjective effects using VAS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in opioid use using the Opioid use Questionnaire [ Time Frame: Daily for 6 weeks ] [ Designated as safety issue: No ]

    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.

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.