Back Pain, Neck Pain
Conditions
Brief 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.
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.
Interventions
DRUGTHC/CBD
Oral solution containing 5mg THC and 50 mg CBD per 1 ml
DRUGTHC
Oral solution containing 5mg THC per 1 ml
DRUGPlacebo
Oral solution containing no active drug
Sponsors
University of Colorado, Denver
Institute of Cannabis Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
One Main Arm is Crossover (Analgesia Arm) One Main Arm is Parallel (Reduction Arm)
Eligibility
Sex/Gender
ALL
Age
21 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain | 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) | Weekly, up to week 22 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Drug Tolerability as measured by study drug use | Daily, up to week 22 | study drug dose, frequency |
| Study Drug Tolerability as measured by side effects | 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 | 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. |
| 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 | 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. |
| Change in use of opioid and non-opioid analgesic medications | Daily, up to week 22 | — |
| Change in abuse liability of cannabis as measured on the Drug Effects Questionnaire (DEQ) for study drug (cannabis) | 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. |
| Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving | 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 |
| Change in opioid craving and withdrawal as measured on a VAS for opioid craving | 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. |
| Change in opioid craving and withdrawal as measured on the Subjective Opiate Withdrawal Scale (SOWS) | Weekly, up to week 22 | The Subjective Opiate Withdrawal Scale (SOWS) is a self-report questionnaire containing 16 symptoms related to opioid withdrawal. |
| Change in opioid craving and withdrawal as measured on the Drug Effect Questionnaire (DEQ) | 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. |
| Change in opioid craving and withdrawal as measured on the Current Opioid Misuse Measure (COMM). | 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. |
| Change in pain sensitivity as measured by pain threshold (kPa) to a pressure stimulus | 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 |
| Change in cognition as assessed by the List Sorting Working Memory Test | 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). |
| Change in cognition as assessed by the Pattern Comparison Processing Speed Test | 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. |
| Change in cognition as assessed by the Oral Symbol Digit Test | 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. |
| Change in cognition as assessed by the Flanker Inhibitory Control and Attention Test | 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). |
| Change in cognition as assessed by the Picture Vocabulary Test | 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. |
| Change in cognition and motor skills as assessed by the Hopkins Verbal Learning Test Revised (HVLT-R) | 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. |
| Change in motor skills as assessed by the Grooved Pegboard Test | 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. |
| Change in motor skills as assessed by the Standardized Field Sobriety Test | 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. |
| Change in participant's perceived improvement in spine pain as measured on the Patient Global Impression of Change Scale (PGIC) | 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. |
Countries
United States
Contacts
CONTACTMustafa Al-Mafrachi, MPH
PRINCIPAL_INVESTIGATOREmily Lindley, PhD
University of Colorado, Denver
Outcome results
None listed