[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05052541":3,"trial-entities:NCT05052541":159,"trial-summary:NCT05052541":162},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":49,"secondary_outcomes":56,"sex":120,"minimum_age":121,"maximum_age":122,"healthy_volunteers":123,"eligibility_criteria":124,"std_ages":128,"locations":131,"central_contacts":150,"overall_officials":155,"references":157,"see_also_links":158},"NCT05052541","20-0701","Safety and Efficacy of Oral Cannabis in Chronic Spine Pain","RECRUITING","2027-06","2026-01","2026-01-23","University of Colorado, Denver","OTHER",true,"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.","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.",[17,18],"Back Pain","Neck Pain",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE3",{"count":25,"type":26},157,"ESTIMATED",[28,40,44],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","THC\u002FCBD","Oral solution containing 5mg THC and 50 mg CBD per 1 ml",[33,34,35,36,37,38,39],"Analgesia Arm: Placebo, then THC, then THC\u002FCBD","Analgesia Arm: Placebo, then THC\u002FCBD, then THC","Analgesia Arm: THC (tetrahydrocannabinol), then THC\u002FCBD (cannabidiol), then Placebo","Analgesia Arm: THC, then Placebo, then THC\u002FCBD","Analgesia Arm: THC\u002FCBD, then Placebo, then THC","Analgesia Arm: THC\u002FCBD, then THC, then Placebo","Reduction Arm: THC\u002FCBD",{"type":29,"name":41,"description":42,"armGroupLabels":43},"THC","Oral solution containing 5mg THC per 1 ml",[33,34,35,36,37,38],{"type":29,"name":45,"description":46,"armGroupLabels":47},"Placebo","Oral solution containing no active drug",[33,34,35,36,37,38,48],"Reduction Arm: Placebo",[50,54],{"measure":51,"description":52,"timeFrame":53},"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\".","Weekly, up to week 22",{"measure":55,"timeFrame":53},"Change in opioid dose as measured in morphine milligram equivalents (MME)",[57,61,63,66,69,71,74,77,80,83,86,89,92,96,99,102,105,108,111,114,117],{"measure":58,"description":59,"timeFrame":60},"Study Drug Tolerability as measured by study drug use","study drug dose, frequency","Daily, up to week 22",{"measure":62,"timeFrame":60},"Study Drug Tolerability as measured by side effects",{"measure":64,"description":65,"timeFrame":53},"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.",{"measure":67,"description":68,"timeFrame":53},"Change in spine-related disability and quality of life as measured on the NIH Task Force on Research Standards for Chronic Low-Back\u002FNeck 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\u002Fneck pain on physical function, emotional health, sleep, everyday activities.",{"measure":70,"timeFrame":60},"Change in use of opioid and non-opioid analgesic medications",{"measure":72,"description":73,"timeFrame":53},"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\u002Fdisliking the drug effect, feeling high, and wanting more drug.",{"measure":75,"description":76,"timeFrame":53},"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",{"measure":78,"description":79,"timeFrame":53},"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.",{"measure":81,"description":82,"timeFrame":53},"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.",{"measure":84,"description":85,"timeFrame":53},"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\u002Fdisliking the drug effect, feeling high, and wanting more opioids.",{"measure":87,"description":88,"timeFrame":53},"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.",{"measure":90,"description":91,"timeFrame":53},"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\u002Fs 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",{"measure":93,"description":94,"timeFrame":95},"Change in cognition as assessed by the List Sorting Working Memory Test","The List Sorting Working Memory Test measures attention\u002Fworking 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).","Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)",{"measure":97,"description":98,"timeFrame":95},"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.",{"measure":100,"description":101,"timeFrame":95},"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.",{"measure":103,"description":104,"timeFrame":95},"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).",{"measure":106,"description":107,"timeFrame":95},"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.",{"measure":109,"description":110,"timeFrame":95},"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\u002Fno recognition trial.",{"measure":112,"description":113,"timeFrame":95},"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.",{"measure":115,"description":116,"timeFrame":95},"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.",{"measure":118,"description":119,"timeFrame":95},"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.","ALL","21 Years","84 Years",false,{"inclusion":125,"exclusion":126,"raw_text":127},[],[],"Some inclusion\u002Fexclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.\n\nInclusion Criteria:\n\nSelf-reported chronic (≥3 months' duration), non-radicular spine pain\n\nExclusion Criteria:\n\nUnwilling\u002Funable 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.\n\nCo-morbid cancer-related pain condition\n\nNeuropathic Pain\n\nA co-morbid pain condition that is of greater severity than the patient's spine pain\n\nSpine or other major surgery within the 3 months prior to enrollment\n\nPlanned surgery or procedural intervention during the study period\n\nAllergy or adverse reaction to cannabis\n\nCurrent or historical substance use disorder\n\nCurrent or historical alcohol use disorder\n\nCurrent or prior cannabis abuse\u002Fdependence\n\nPositive result for use of amphetamine\u002Fmethamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen\n\nCurrent use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines\n\nPrior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)\n\nHistory or diagnosis of schizophrenia, bipolar or a psychotic disorder\n\nHistory of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant\n\nCurrent or historical severe depression\n\nCurrent suicidal ideation\n\nDiagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury)\n\nUncontrolled hypertension (\\>139\u002F89)\n\nAbnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician\n\nKnown hepatic disease or dysfunction, or identification of such on screening laboratory studies\n\nKnown cardiovascular disease\n\nAbnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD\n\nCognitive disability that interferes with ability to provide consent or understand study procedure\n\nHistory of seizure disorder\n\nAny medical condition for which immunosuppressive therapy is required.\n\nInability to refrain from using tobacco for at least 4 hours\n\nPresence 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\n\nPending legal action or workers compensation\n\nPregnant females or females intending to become pregnant during the study period\n\nUnwilling 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)\n\nLactating females\n\nAnalgesia Arm Exclusion Criteria:\n\nUnwilling\u002Funable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study\n\nReduction Arm Exclusion Criteria:\n\nNot interested in reducing or discontinuing use of prescribed opioids for chronic pain\n\nUnwilling to allow the study team to communicate with the participant's opioid prescribing provider\n\n\\*Some inclusion\u002Fexclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.",[129,130],"ADULT","OLDER_ADULT",[132],{"facility":133,"status":7,"city":134,"state":135,"zip":136,"country":137,"contacts":138,"geoPoint":147},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States",[139,144],{"name":140,"role":141,"phone":142,"email":143},"Emily Lindley, PhD","CONTACT","303-724-0239","emily.lindley@cuanschutz.edu",{"name":145,"role":146},"Rachael Rzasa Lynn, MD","PRINCIPAL_INVESTIGATOR",{"lat":148,"lon":149},39.72943,-104.83192,[151],{"name":152,"role":141,"phone":153,"email":154},"Mustafa Al-Mafrachi, MPH","303-724-0923","spinepainstudy@cuanschutz.edu",[156],{"name":140,"affiliation":11,"role":146},[],[],{"nct_id":4,"conditions":160,"biomarkers":161},[17,18],[],{"nct_id":4,"found":13,"summary":163,"prompt_version":173},{"design":164,"status":165,"heading":166,"summary":167,"follow_up":168,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"This is a randomized, placebo-controlled study with two main parts, involving a total of 157 participants. One part uses a crossover design where participants receive different treatments at different times, and the other uses a parallel design where participants receive one treatment throughout.","completed","Oral Cannabis for Chronic Spine Pain","This study is looking at how well oral cannabis solutions can help people with long-lasting back or neck pain. Researchers want to see if solutions containing THC\u002FCBD or just THC can reduce pain and help people lower their use of opioid medications. You might be able to join if you are between 21 and 84 years old and have had chronic spine pain for at least three months. The study will measure changes in your pain levels using a Visual Analog Scale (VAS) and track any changes in your opioid dose over several weeks. The study is currently unclear on its recruitment status and plans to enroll 157 participants.","Your pain and opioid dose will be measured weekly for up to 22 weeks.",109,"You would need to stop using cannabis (medical or recreational) for 14 days before starting the study and throughout your participation. Your pain levels and opioid doses will be measured weekly for up to 22 weeks.","Not stated in the trial record.",[30,41],"v2"]