Investigation of Cannabis for Pain and Inflammation in Lung Cancer

NCT02675842 | Withdrawn Phase 1 DMC

• 1 other identifier: 7221
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (7)

• Change in pain ratings using The McGill Pain Questionnaire

  Participants will be asked to rate their pain over the 6 weeks of receiving active cannabis vs placebo.

  6 weeks

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

  Participants will be asked to rate physical symptoms for the 6 weeks of the study.

  6 weeks

• changes in physical and emotional well being using RAND 36 item medical outcomes survey

  6 weeks

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

  6 weeks

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

  6 weeks

• changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom

  6 weeks

• Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire

  6 weeks

Secondary Outcomes (10)

• Assessment of subjective effects using VAS

  6 weeks

• change in eating measured using food diary

  weekly for 6 weeks

• Change in mood using the Hamilton Depression Rating Scale

  6 weeks

• Change in mood Hamilton Anxiety Rating Scale

  6 weeks

• Change in mood using the Montgomery-Asberg Depression Rating Scale

  6 weeks

Study Arms (2)

Smoked Cannabis High CBD/low THC

ACTIVE COMPARATOR

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 Cannabis High CBD/low THC

Smoked Placebo Cannabis Low CBD/low THC

PLACEBO COMPARATOR

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.

Drug: Smoked Placebo Cannabis Low CBD/low THC

Interventions

Smoked Cannabis High CBD/low THC DRUG

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.

Smoked Cannabis High CBD/low THC

Smoked Placebo Cannabis Low CBD/low THC DRUG

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.

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:

• Diagnosis of Lung Cancer receiving RT.
• Age 21- 60
• Able to give informed consent, and comply with study procedures.
• 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.

You may not qualify if:

• 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.
• 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 history of substance use disorder other than nicotine, such as opiate disorder

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Diana Martinez, MD

  Columbia University/NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry at CUMC

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 5, 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