Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

Обзор

The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.

Подробное описание

This randomized, placebo-controlled clinical trial is designed to elucidate the role of extended oral cannabis treatment in the alleviation of chronic spine pain and reduction of high-dose opioid use. This trial includes two study arms: Analgesia Arm and Reduction Arm. The Analgesia Arm uses a within-subject crossover design to determine whether daily treatment with an oral cannabis solution for 6 weeks significantly reduces spine pain compared to placebo. The Reduction Arm uses a parallel design to determine whether daily treatment with an oral cannabis solution for 13 weeks results in a greater reduction of pain and opioid intake than placebo treatment. It will also assess the impact of extended cannabis treatment on opioid craving and symptoms of opioid withdrawal in participants tapering their high-dose opioids.

Вмешательства

• Препарат THC/CBD
  Oral solution containing 5mg THC and 50 mg CBD per 1 ml
• Препарат THC
  Oral solution containing 5mg THC per 1 ml
• Препарат Placebo
  Oral solution containing no active drug

Первичные конечные точки

• Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain [Срок оценки: Weekly, up to week 22]
• Change in opioid dose as measured in morphine milligram equivalents (MME) [Срок оценки: Weekly, up to week 22]

Вторичные конечные точки (12)

• Study Drug Tolerability as measured by study drug use [Срок оценки: Daily, up to week 22]
• Study Drug Tolerability as measured by side effects [Срок оценки: Daily, up to week 22]
• Change in spine-related disability and quality of life as measured on the NIH Patient Reported Outcomes Measurement System (PROMIS)-29 [Срок оценки: Weekly, up to week 22]
• Change in spine-related disability and quality of life as measured on the NIH Task Force on Research Standards for Chronic Low-Back/Neck Pain Minimal Dataset [Срок оценки: Weekly, up to week 22]
• Change in use of opioid and non-opioid analgesic medications [Срок оценки: Daily, up to week 22]
• Change in abuse liability of cannabis as measured on the Drug Effects Questionnaire (DEQ) for study drug (cannabis) [Срок оценки: Weekly, up to week 22]
• Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving [Срок оценки: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on a VAS for opioid craving [Срок оценки: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on the Subjective Opiate Withdrawal Scale (SOWS) [Срок оценки: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on the Drug Effect Questionnaire (DEQ) [Срок оценки: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on the Current Opioid Misuse Measure (COMM). [Срок оценки: Weekly, up to week 22]
• Change in pain sensitivity as measured by pain threshold (kPa) to a pressure stimulus [Срок оценки: Weekly, up to week 22]

Критерии участия

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Критерии включения

Self-reported chronic (≥3 months' duration), non-radicular spine pain

Критерии исключения

Unwilling/unable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than study drug). This includes whole plant inhalation, edibles, extracts, and topicals.

Co-morbid cancer-related pain condition

Neuropathic Pain

A co-morbid pain condition that is of greater severity than the patient's spine pain

Spine or other major surgery within the 3 months prior to enrollment

Planned surgery or procedural intervention during the study period

Allergy or adverse reaction to cannabis

Current or historical substance use disorder

Current or historical alcohol use disorder

Current or prior cannabis abuse/dependence

Positive result for use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen

Current use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines

Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)

History or diagnosis of schizophrenia, bipolar or a psychotic disorder

History of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant

Current or historical severe depression

Current suicidal ideation

Diagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury)

Uncontrolled hypertension (>139/89)

Abnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician

Known hepatic disease or dysfunction, or identification of such on screening laboratory studies

Known cardiovascular disease

Abnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD

Cognitive disability that interferes with ability to provide consent or understand study procedure

History of seizure disorder

Any medical condition for which immunosuppressive therapy is required.

Inability to refrain from using tobacco for at least 4 hours

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data

Pending legal action or workers compensation

Pregnant females or females intending to become pregnant during the study period

Unwilling to use one of the accepted forms of contraception during the study period and for at least 60 days after completion of the study (females of childbearing potential and males with sexual partners of childbearing potential)

Lactating females

Analgesia Arm Exclusion Criteria:

Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study

Reduction Arm Exclusion Criteria:

Not interested in reducing or discontinuing use of prescribed opioids for chronic pain

Unwilling to allow the study team to communicate with the participant's opioid prescribing provider

\*Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT05052541 · 20-0701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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