Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
Condition: Cannabis; Low Back Pain; Neuropathic Pain
MeSH terms: Neuralgia; Back Pain; Low Back Pain; Marijuana Abuse
Intervention: Placebos; dronabinol; Vaporized Cannabis 3.7% THC/5.6% CBD
Intervention description: Administration of vaporized cannabis plus either dronabinol or placebo pill; Administration of vaporized cannabis plus either dronabinol or placebo pill; Administration of vaporized cannabis plus either dronabinol or placebo pill
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will involve treating low back pain associated with nerve injury with oral
      delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research
      subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or
      placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol
      and vaporized 3.7% Δ9-THC/5.6% CBD .
    

Eligibility criteria:

        Inclusion Criteria:

        Age greater than 18. Presence of chronic low back pain (CLBP) defined as the response to
        two questions 1) How long has back pain been an ongoing problem for you? 2) How often has
        low back pain been an ongoing problem for you over the past 6 months? A response of greater
        than 3 months to question 1 and a response of "at least half the days in the past 6 months"
        to question 2 will define CLBP according to the NIH Task Force on Research Standards for
        Chronic Low Back Pain.

        The numerical pain intensity must be greater than 3/10 each day during the one-week
        observation period.

        To avoid confounding by concurrent medications, participants will have had a stable
        analgesic regimen that they will continue throughout the study To obviate residual
        neuropsychological effects from cannabis exposure, participants will be abstinent from this
        herbal medicine for 7 days prior to study entry.

        Exclusion Criteria:

        Presence of another painful condition of greater severity than the neuropathic pain
        condition which is being studied.

        History of traumatic brain injury. Clinically significant or unstable medical condition.
        Individuals with significant cardiovascular, hepatic or renal disease, uncontrolled
        hypertension, and chronic pulmonary disease (eg, asthma, COPD), will be excluded. If
        warranted clinically, subjects will undergo laboratory evaluation (blood chemistry,
        electrocardiogram, urinalysis, toxicology screening for confirmation. Females of
        childbearing potential will undergo pregnancy testing.

        A positive result on toxicity screening will exclude individuals from participation. A
        urine drug test that screens for 5 categories of drugs: marijuana (Δ9-THC), cocaine,
        amphetamines/methamphetamines, opiates, benzodiazepines and phencyclidine (PCP) will be
        employed. A positive result for opioids and/or THC will not be exclusionary if the patient
        is receiving a prescription for an opioid and/or THC.

        Allergy to sesame oil, lactose, or gelatin Vascular disease, especially Raynauld's
        syndrome, systolic blood pressure > 170 mm, diastolic blood pressure > 100 mm Recent
        injuries to the upper extremity Cognitive impairment, such as Dementia or Alzheimer's
        Disease Substance Abuse History: The Substance Abuse Module of the Diagnostic Interview
        Schedule for the Diagnostic and Statistical Manual (DSM)-IV will be administered to exclude
        individuals with current substance use disorders.

        Pregnancy as ascertained by a mandatory commercial pregnancy test Past history of suicide
        attempt. Cannabis can exacerbate pre-existing schizophrenia, and has been linked to an
        increase in the risk of suicide in such patients. In patients with bipolar disorder,
        cannabis use has been associated with worsening of manic and psychotic symptoms. Such
        findings suggest that cannabis is contraindicated in individuals with serious mental health
        issues, a line of reasoning that will be observed in the present study by excluding
        patients in the bipolar/schizoaffective/schizophrenic spectrum.

        Suicidality. Exposure to cannabis does not lead to depression but it may be associated with
        suicidal thoughts and attempts. Therefore, the Beck Depression Inventory (BDI)-II will be
        used to measure suicidal ideation.