Health TrialsbyHealthPanel

Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

ConditionsBack PainNeck Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-84
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

157 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then PlaceboExperimental treatment 3 interventions
Group B: Analgesia Arm: THC, then Placebo, then THC/CBDExperimental treatment 3 interventions
Group C: Analgesia Arm: THC/CBD, then THC, then PlaceboExperimental treatment 3 interventions
Group D: Analgesia Arm: THC/CBD, then Placebo, then THCExperimental treatment 3 interventions
Group E: Analgesia Arm: Placebo, then THC, then THC/CBDExperimental treatment 3 interventions
Group F: Analgesia Arm: Placebo, then THC/CBD, then THCExperimental treatment 3 interventions
Group G: Reduction Arm: THC/CBDExperimental treatment 1 intervention
Group H: Reduction Arm: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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".

Time frame
Weekly, up to week 22
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

study drug dose, frequency

Time frame
Daily, up to week 22
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

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.

Time frame
Weekly, up to week 22
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

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.

Time frame
Weekly, up to week 22

Other outcomes

1

Change in 2-arachidonoylglycerol levels as measured in plasma

2-arachidonoylglycerol will be measured in pmol/ml

Time frame
Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
2

Change in N-arachidonoylethanolamine levels as measured in plasma

N-arachidonoylethanolamine will be measured in pmol/ml

Time frame
Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
3

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

TNF-α will be measured in pg/ml

Time frame
Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)
4

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

CRP will be measured in mg/L

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Institute of Cannabis Research

Collaborator

Source ClinicalTrials.gov
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