Investigation of Cannabis for Chronic Pain and Palliative Care

NCT02683018 | Withdrawn Phase 1 DMC

• 1 other identifier: 7220
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Change in pain ratings using the McGill Pain Questionnaire

  Participants will be asked to rate their pain over the 4 weeks of receiving active cannabis vs placebo.

  4 weeks

• Change in sickness-related impairment using the Sickness Impact Profile

  Participants will be asked to rate physical symptoms for the 4 weeks of the study.

  4 weeks

• changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument

  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.

  4 weeks

• Changes in symptoms of pain using the 9 item Brief Pain Inventory

  4 weeks

Secondary Outcomes (11)

• Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)

  4 weeks

• Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS)

  4 weeks

• Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5)

  4 weeks

• Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire

  4 weeks

• Changes in quality of life using the McGill Quality of Life Questionnaire

  4 weeks

Study Arms (2)

Smoked Cannabis High CBD/low THC

ACTIVE COMPARATOR

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.

Drug: Smoked Cannabis High CBD/low THC

Smoked Placebo Cannabis Low CBD/low THC

PLACEBO COMPARATOR

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.

Drug: Smoked Placebo Cannabis Low CBD/low THC

Interventions

Smoked Cannabis High CBD/low THC DRUG

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.

Also known as: cannabis cigarettes (15.76% CBD; 3.11% THC)

Smoked Cannabis High CBD/low THC

Smoked Placebo Cannabis Low CBD/low THC DRUG

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.

Also known as: cannabis cigarettes (0.01% THC; 0.00% CBD)

Smoked Placebo Cannabis Low CBD/low THC

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age 21-60
• Able to give informed consent, and comply with study procedures
• Experience inhaling substances.

You may not qualify if:

• 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
• 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.
• Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant
• Current (weekly) use of cannabis
• Participants on supplemental oxygen
• Participants with a substance use disorder involving marijuana or opioids.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Diana Martinez, MD

  New York Sate Psychiatric Institute/ Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share