Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain

NCT02460692 | Completed Phase 2 Results DMC

• 2 other identifiers: 1R01DA038634-01A1R01DA038634
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Cannabis; Low Back Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Intensity

  The primary outcome is self-reported daily average numerical pain intensity during the past 24 hours. The numerical pain intensity is an 11-point pain intensity numerical rating scale (PI-NRS), where 0 equals no pain and 10 equals worst possible pain. The time frame includes baseline and weeks 1, 3, 5, 7, 8. Baseline is the pain tensity reported at the first day in the daily diary, before the first dose. The follow-up pain intensities (weeks 1, 3, 5, 7, 8) are the daily diary average pain intensities since the previously reported timepoint.

  8 weeks

Secondary Outcomes (16)

• Repeated Measures Recommended Minimal Dataset (NIH Task Force on Chronic Low Back Pain)

  8 weeks

• Neuropathic Pain Scale

  8 weeks

• Hopkins Verbal Learning Test

  8 weeks

• Grooved Pegboard Test - Dominant Hand

  8 weeks

• Wechsler Adult Intelligence Scale-III Digit Symbol Test

  8 weeks

Study Arms (3)

Placebos

PLACEBO COMPARATOR

The present study is designed to evaluate whether or not a medium dose of cannabis (3.7% delta-9-THC/5.6% CBD) can maintain an analgesic response over an eight week period compared to placebo.

Drug: Placebos

Dronabinol

ACTIVE COMPARATOR

A direct comparison of cannabis and dronabinol has not been performed in a clinical population. The present study will fill this void by performing a randomized, controlled 8 week trial comparing the effectiveness of oral versus vaporized cannabis in patients with neuropathic low back pain.

Drug: dronabinol

Vaporized Cannabis 3.7% THC/5.6% CBD

EXPERIMENTAL

The eight week outpatient study will compare the efficacy and side effect profile of cannabis (3.7%THC/5.6%CBD) and dronabinol. We will also perform a human laboratory experiment evaluating driving using the same study medications that subjects received during their 8 week outpatient treatment.

Drug: Vaporized Cannabis 3.7% THC/5.6% CBD

Interventions

Placebos DRUG

Administration of vaporized cannabis plus either dronabinol or placebo pill

Also known as: sugar pill

Placebos

dronabinol DRUG

Administration of vaporized cannabis plus either dronabinol or placebo pill

Also known as: Marinol

Dronabinol

Vaporized Cannabis 3.7% THC/5.6% CBD DRUG

Administration of vaporized cannabis plus either dronabinol or placebo pill

Also known as: marijuana

Vaporized Cannabis 3.7% THC/5.6% CBD

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UC Center for Medicinal Cannabis Research, UC San Diego

San Diego, California, 92103, United States

Location

Related Publications (4)

• Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.

  PMID: 18403272 BACKGROUND

• Wilsey B, Marcotte T, Deutsch R, Gouaux B, Sakai S, Donaghe H. Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain. 2013 Feb;14(2):136-48. doi: 10.1016/j.jpain.2012.10.009. Epub 2012 Dec 11.

  PMID: 23237736 BACKGROUND

• Wilsey B, Atkinson JH, Marcotte TD, Grant I. The Medicinal Cannabis Treatment Agreement: Providing Information to Chronic Pain Patients Through a Written Document. Clin J Pain. 2015 Dec;31(12):1087-96. doi: 10.1097/AJP.0000000000000145.

  PMID: 25370134 BACKGROUND

• Grant I, Atkinson JH, Gouaux B, Wilsey B. Medical marijuana: clearing away the smoke. Open Neurol J. 2012;6:18-25. doi: 10.2174/1874205X01206010018. Epub 2012 May 4.

  PMID: 22629287 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse; Low Back Pain; Neuralgia

Interventions

Sugars; Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Thomas D. Marcotte, PhD
• Organization: University of California, San Diego

tmarcotte@health.ucsd.edu

619-543-5044

Study Officials

• Thomas D Marcotte, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: December 1, 2016
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Locations

US (1)