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NCT Number: NCT05052541

Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

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.

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Key information

Conditions

Back Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Emily Lindley, PhD

CONTACT

[email protected]

303-724-0239

Rachael Rzasa Lynn, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

THC/CBD

Drug

Oral solution containing 5mg THC and 50 mg CBD per 1 ml

THC

Drug

Oral solution containing 5mg THC per 1 ml

Placebo

Drug

Oral solution containing no active drug

Primary outcomes

  1. Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain

    Time frame: Weekly, up to week 22

    The Visual Analog Scale (VAS) for pain is a 0-100mm visual scale anchored by "no pain" and "worst possible pain".

  2. Change in opioid dose as measured in morphine milligram equivalents (MME)

    Time frame: Weekly, up to week 22

Secondary outcomes

  1. Study Drug Tolerability as measured by study drug use

    Time frame: Daily, up to week 22

    study drug dose, frequency

  2. Study Drug Tolerability as measured by side effects

    Time frame: Daily, up to week 22

  3. Change in spine-related disability and quality of life as measured on the NIH Patient Reported Outcomes Measurement System (PROMIS)-29

    Time frame: Weekly, up to week 22

    The NIH Patient Reported Outcomes Measurement System (PROMIS)-29 is a collection of 4-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item.

  4. 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

    Time frame: Weekly, up to week 22

    The NIH Task Force on Research Standards for Chronic Low-Back Pain Minimal Dataset (and the modified Dataset for neck pain) assesses the influence of back/neck pain on physical function, emotional health, sleep, everyday activities.

  5. Change in use of opioid and non-opioid analgesic medications

    Time frame: Daily, up to week 22

  6. Change in abuse liability of cannabis as measured on the Drug Effects Questionnaire (DEQ) for study drug (cannabis)

    Time frame: Weekly, up to week 22

    The Drug Effects Questionnaire (DEQ) for study drug (cannabis) assesses the subjective effects after taking a drugs, including feeling a drug effect, liking/disliking the drug effect, feeling high, and wanting more drug.

  7. Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving

    Time frame: Weekly, up to week 22

    The VAS for study drug (cannabis) craving is a 100 mm visual scale anchored by "not at all" and "extremely" when asked about drug craving in the past week

  8. Change in opioid craving and withdrawal as measured on a VAS for opioid craving

    Time frame: Weekly, up to week 22

    The VAS for opioid craving is a 100 mm visual scale anchored by "not at all" and "extremely" when asked about opioid craving in the past week.

  9. Change in opioid craving and withdrawal as measured on the Subjective Opiate Withdrawal Scale (SOWS)

    Time frame: Weekly, up to week 22

    The Subjective Opiate Withdrawal Scale (SOWS) is a self-report questionnaire containing 16 symptoms related to opioid withdrawal.

  10. Change in opioid craving and withdrawal as measured on the Drug Effect Questionnaire (DEQ)

    Time frame: Weekly, up to week 22

    The Drug Effects Questionnaire (DEQ) for opioids assesses the subjective effects after taking opioids, including feeling a drug effect, liking/disliking the drug effect, feeling high, and wanting more opioids.

  11. Change in opioid craving and withdrawal as measured on the Current Opioid Misuse Measure (COMM).

    Time frame: Weekly, up to week 22

    Current Opioid Misuse Measure (COMM) is a brief patient self-assessment to help identify participants who exhibit aberrant behaviors associated with the misuse of opioid medications.

  12. Change in pain sensitivity as measured by pain threshold (kPa) to a pressure stimulus

    Time frame: Weekly, up to week 22

    Pressure output on a computer-controlled pressure algometer will be set to 10 kPa/s and participants will be instructed to indicate when the sensation changes from one of pressure alone to one of pressure and pain (pain threshold) by pressing a button on the remote-control indicator

  13. Change in cognition as assessed by the List Sorting Working Memory Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The List Sorting Working Memory Test measures attention/working memory. Participants recall and sequence different visually and orally presented stimuli (e.g., participants are asked to list a set of given animals in order by size, from smallest to largest).

  14. Change in cognition as assessed by the Pattern Comparison Processing Speed Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Pattern Comparison Processing Speed Test is a measure of processing speed. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible.

  15. Change in cognition as assessed by the Oral Symbol Digit Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Oral Symbol Digit Test is a measure of processing speed. Symbols on the screen are associated with a number in a key. Participants are then presented symbols without numbers. Participants say each number that goes with each presented symbol for 90 seconds.

  16. Change in cognition as assessed by the Flanker Inhibitory Control and Attention Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Flanker Inhibitory Control and Attention Test measures attention and inhibitory control. Participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it (i.e., the flankers, two on either side).

  17. Change in cognition as assessed by the Picture Vocabulary Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Picture Vocabulary Test measures receptive vocabulary. Respondents select pictures (from arrays) that most closely match the meanings of presented words.

  18. Change in cognition and motor skills as assessed by the Hopkins Verbal Learning Test Revised (HVLT-R)

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The HVLT-R is a measure of verbal learning and memory. Participants are asked to learn a 12-item word list over three trials (total immediate learning). A delayed free recall trial is administered after 20 minutes, followed by a yes/no recognition trial.

  19. Change in motor skills as assessed by the Grooved Pegboard Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Grooved Pegboard is a test of fine motor coordination and speed. In this test, participants place 25 small metal pegs into holes on a 3"x3" metal board as quickly as possible. All pegs are alike and have a ridge on 1 side that corresponds to a randomly oriented notch in each hole on the metal board.

  20. Change in motor skills as assessed by the Standardized Field Sobriety Test

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Standardized Field Sobriety Test is intended to detect driving impairments due to recent alcohol or drug use.

  21. Change in participant's perceived improvement in spine pain as measured on the Patient Global Impression of Change Scale (PGIC)

    Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    The Patient Global Impression of Change Scale (PGIC) is a 7-point scale depicting a patient's rating of overall improvement.

Other outcomes

  1. Change in 2-arachidonoylglycerol levels as measured in plasma

    Time frame: Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    2-arachidonoylglycerol will be measured in pmol/ml

  2. Change in N-arachidonoylethanolamine levels as measured in plasma

    Time frame: Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    N-arachidonoylethanolamine will be measured in pmol/ml

  3. Change in tumor necrosis factor alpha (TNF-α) levels as measured in plasma

    Time frame: Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    TNF-α will be measured in pg/ml

  4. Change in C-reactive protein (CRP) levels as measured in plasma

    Time frame: Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

    CRP will be measured in mg/L

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa Al-Mafrachi, MPH

CONTACT

[email protected]

303-724-0923

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Institute of Cannabis Research

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2021
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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