Back PainPhase 3NCT05052541
Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
A Phase 3 study testing THC/CBD and THC in people with Back Pain and Neck Pain, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 84 years
- What is being tested?
- THC/CBD and THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported chronic (≥3 months' duration), non-radicular spine pain
Who cannot join
- 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
Show all 38Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Emily Lindley, PhD, 303-724-0239, emily.lindley@cuanschutz.edu
Rachael Rzasa Lynn, MD
About this study
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.
Read the detailed description
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.
- Being tested
- THC/CBD, THC, Placebo
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC/CBDDrug
Oral solution containing 5mg THC and 50 mg CBD per 1 ml
THCDrug
Oral solution containing 5mg THC per 1 ml
PlaceboDrug
Oral solution containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo | Experimental | Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD; Drug: THC; Drug: Placebo |
| Analgesia Arm: THC, then Placebo, then THC/CBD | Experimental | Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD; Drug: THC; Drug: Placebo |
| Analgesia Arm: THC/CBD, then THC, then Placebo | Experimental | Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD; Drug: THC; Drug: Placebo |
| Analgesia Arm: THC/CBD, then Placebo, then THC | Experimental | Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD; Drug: THC; Drug: Placebo |
| Analgesia Arm: Placebo, then THC, then THC/CBD | Experimental | Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD; Drug: THC; Drug: Placebo |
| Analgesia Arm: Placebo, then THC/CBD, then THC | Experimental | Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD; Drug: THC; Drug: Placebo |
| Reduction Arm: THC/CBD | Experimental | Subjects in this parallel arm will be assigned to 13 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: THC/CBD |
| Reduction Arm: Placebo | Placebo comparator | Subjects in this parallel arm will be assigned to 13 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain
The Visual Analog Scale (VAS) for pain is a 0-100mm visual scale anchored by "no pain" and "worst possible pain".
Measured: Weekly, up to week 22
Change in opioid dose as measured in morphine milligram equivalents (MME)
Measured: Weekly, up to week 22
Secondary outcomes (21)
Study Drug Tolerability as measured by study drug use
study drug dose, frequency
Measured: Daily, up to week 22
Study Drug Tolerability as measured by side effects
Measured: 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
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.
Measured: 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
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.
Measured: Weekly, up to week 22
Change in use of opioid and non-opioid analgesic medications
Measured: Daily, up to week 22
Change in abuse liability of cannabis as measured on the Drug Effects Questionnaire (DEQ) for study drug (cannabis)
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.
Measured: Weekly, up to week 22
Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving
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
Measured: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on a VAS for opioid craving
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.
Measured: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on the Subjective Opiate Withdrawal Scale (SOWS)
The Subjective Opiate Withdrawal Scale (SOWS) is a self-report questionnaire containing 16 symptoms related to opioid withdrawal.
Measured: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on the Drug Effect Questionnaire (DEQ)
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.
Measured: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on the Current Opioid Misuse Measure (COMM).
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.
Measured: Weekly, up to week 22
Change in pain sensitivity as measured by pain threshold (kPa) to a pressure stimulus
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
Measured: Weekly, up to week 22
Change in cognition as assessed by the List Sorting Working Memory Test
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).
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in cognition as assessed by the Pattern Comparison Processing Speed Test
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.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in cognition as assessed by the Oral Symbol Digit Test
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.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in cognition as assessed by the Flanker Inhibitory Control and Attention Test
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).
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in cognition as assessed by the Picture Vocabulary Test
The Picture Vocabulary Test measures receptive vocabulary. Respondents select pictures (from arrays) that most closely match the meanings of presented words.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in cognition and motor skills as assessed by the Hopkins Verbal Learning Test Revised (HVLT-R)
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.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in motor skills as assessed by the Grooved Pegboard Test
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.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in motor skills as assessed by the Standardized Field Sobriety Test
The Standardized Field Sobriety Test is intended to detect driving impairments due to recent alcohol or drug use.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Change in participant's perceived improvement in spine pain as measured on the Patient Global Impression of Change Scale (PGIC)
The Patient Global Impression of Change Scale (PGIC) is a 7-point scale depicting a patient's rating of overall improvement.
Measured: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study startJan 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One Main Arm is Crossover (Analgesia Arm) One Main Arm is Parallel (Reduction Arm)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cannabis Research
- Responsible party
- Sponsor
- Investigators
- Emily Lindley, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052541
- Sponsor's protocol ID
- 20-0701
- Status last verified
- Jan 2026
- First submitted
- 18 Aug 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
- ClinicalTrials.gov ID
- NCT05052541
- Acronym / sponsor ID
- 20-0701
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Institute of Cannabis Research
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- One Main Arm is Crossover (Analgesia Arm) One Main Arm is Parallel (Reduction Arm)
| Arm | Type | Receives |
|---|---|---|
| Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo | Experimental | Drug: THC/CBD, Drug: THC, Drug: PlaceboSubjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day. |
| Analgesia Arm: THC, then Placebo, then THC/CBD | Experimental | Drug: THC/CBD, Drug: THC, Drug: PlaceboSubjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day. |
| Analgesia Arm: THC/CBD, then THC, then Placebo | Experimental | Drug: THC/CBD, Drug: THC, Drug: PlaceboSubjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day. |
| Analgesia Arm: THC/CBD, then Placebo, then THC | Experimental | Drug: THC/CBD, Drug: THC, Drug: PlaceboSubjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day. |
| Analgesia Arm: Placebo, then THC, then THC/CBD | Experimental | Drug: THC/CBD, Drug: THC, Drug: PlaceboSubjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day. |
| Analgesia Arm: Placebo, then THC/CBD, then THC | Experimental | Drug: THC/CBD, Drug: THC, Drug: PlaceboSubjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day. |
| Reduction Arm: THC/CBD | Experimental | Drug: THC/CBDSubjects in this parallel arm will be assigned to 13 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day. |
| Reduction Arm: Placebo | Placebo comparator | Drug: PlaceboSubjects in this parallel arm will be assigned to 13 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day. |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported chronic (≥3 months' duration), non-radicular spine pain
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC/CBDOral solution containing 5mg THC and 50 mg CBD per 1 ml | Drug | Analgesia Arm: Placebo, then THC, then THC/CBD, Analgesia Arm: Placebo, then THC/CBD, then THC, Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo, Analgesia Arm: THC, then Placebo, then THC/CBD, Analgesia Arm: THC/CBD, then Placebo, then THC, Analgesia Arm: THC/CBD, then THC, then Placebo, Reduction Arm: THC/CBD |
| THCOral solution containing 5mg THC per 1 ml | Drug | Analgesia Arm: Placebo, then THC, then THC/CBD, Analgesia Arm: Placebo, then THC/CBD, then THC, Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo, Analgesia Arm: THC, then Placebo, then THC/CBD, Analgesia Arm: THC/CBD, then Placebo, then THC, Analgesia Arm: THC/CBD, then THC, then Placebo |
| PlaceboOral solution containing no active drug | Drug | Analgesia Arm: Placebo, then THC, then THC/CBD, Analgesia Arm: Placebo, then THC/CBD, then THC, Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo, Analgesia Arm: THC, then Placebo, then THC/CBD, Analgesia Arm: THC/CBD, then Placebo, then THC, Analgesia Arm: THC/CBD, then THC, then Placebo, Reduction Arm: Placebo |
Primary outcome
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".
Change in opioid dose as measured in morphine milligram equivalents (MME)
Time frame: Weekly, up to week 22
21 secondary outcomes
Study Drug Tolerability as measured by study drug use
Time frame: Daily, up to week 22
Study Drug Tolerability as measured by side effects
Time frame: 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
Time frame: 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
Time frame: Weekly, up to week 22
Change in use of opioid and non-opioid analgesic medications
Time frame: Daily, up to week 22
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
Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving
Time frame: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on a VAS for opioid craving
Time frame: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on the Subjective Opiate Withdrawal Scale (SOWS)
Time frame: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on the Drug Effect Questionnaire (DEQ)
Time frame: Weekly, up to week 22
Change in opioid craving and withdrawal as measured on the Current Opioid Misuse Measure (COMM).
Time frame: Weekly, up to week 22
Change in pain sensitivity as measured by pain threshold (kPa) to a pressure stimulus
Time frame: Weekly, up to week 22
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)
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)
Change in cognition as assessed by the Oral Symbol Digit Test
Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
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)
Change in cognition as assessed by the Picture Vocabulary Test
Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
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)
Change in motor skills as assessed by the Grooved Pegboard Test
Time frame: Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Lindley, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing THC/CBD and THC in people with Back Pain and Neck Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Al-Mafrachi, MPH (303-724-0923, spinepainstudy@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain (time frame: Weekly, up to week 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.