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.

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.

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.

Cannabis

Low Back Pain

Neuropathic Pain

Administration of vaporized cannabis plus either dronabinol or placebo pill

Placebos

dronabinol

Vaporized Cannabis 3.7% THC/5.6% CBD

UC Center for Medicinal Cannabis Research, UC San Diego

Trial of Dronabinol and Vaporized Cannabis in Neuropathic Low Back Pain

A Randomized, Cross-Over Controlled Trial of Dronabinol and Vaporized Cannabis in Neuropathic Low Back Pain

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

A Task Force was convened by the NIH Pain Consortium, with the goal of developing research standards for chronic low back pain. The results included recommendations for a repeated measures dataset in order to establish greater consistency in reporting in order to facilitate comparisons among studies. The repeated measure minimal dataset is based upon scores based upon the Patient-Reported Outcomes Measurement Information System ® (PROMIS). These items yield a classification of impacts on the lives of patients that range from 8 (least impact) to 50 (greatest impact).

The Neuropathic Pain Scale is an 11-point numerical scale consisting of 13 questions that ask ratings of various pain descriptors (e.g., pain intensity, sharpness, dullness)

The Hopkins Verbal Learning Test provides information on the ability to learn and immediately recall verbal information across trials, as well at the ability to retain, reproduce, and recognize this information after a delay. A list of 12 words is presented to the subject over three trials. After each trial, the subject is to recall as many items as possible from the list in any desired order. A 20-minute delay follows the administration of the three trials, after which the subject is asked to recall the list.

The Grooved Pegboard Test is a test of fine motor coordination and speed. Subjects are required to place 25 small metal pegs into holes on a 3" x 3" metal board. All pegs are alike and have a ridge on one side, which corresponds to a notch in each hole on the board. First the dominant hand is tested, and subjects are asked to place the pegs in the holes as fast as they can. This is then repeated with the non-dominant hand, and the total time for each hand is recorded.

The Digit Symbol test measures concentration, psychomotor speed, and graphomotor abilities. This pen and paper test involves having subjects substitute a series of symbols with numbers as quickly and accurately as possible during a 120 second period. The results are expressed as the number of correct substitutions.

This questionnaire contains 65 words/statements that describe feelings people have. The test requires the patient to indicate for each word or statement how he or she has been feeling in the past week. There are 6 subscales: tension-anxiety (9 items, score range: 0-36), depression (15 items, range 0-60), anger-hostility (12 items, range 0-48), vigor-activity (8 items, range 0-32), fatigue (7 items, range 0-28), confusion-bewilderment (7 items, range 0-28). The total mood disturbance equals adding subscales and subtracting vigor (range 0-200)

The Beck Depression Inventory is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex.

A total of 15 separate VAS ratings will be presented as a 100-mm horizontal line, anchored on the left with `not at all' and on the right with `extremely'. Participants will pencil in a vertical line along the horizontal line that represents their current feeling (questions usually phrased, `During the past week, did you feel ___after consuming the vaporized cannabis?'). Ratings will be: any drug effect, a good drug effect, a bad drug effect, high, drunk, impaired, stoned, as if you liked the drug effect, sedated, confused, nauseous, like you desired more of the drug, anxious, down, and very hungry.

The Marijuana subscale (M-scale) of the Addiction Research Center Inventory consists of 12 true or false questions corresponding to symptoms of cannabis intoxication; the maximum possible score is 12. The questions will be rephrased to evaluate the experience from the past week rather than an acute response to cannabis.

Each Cold Pressure Test will begin with an immersion of the left hand into a warm water bath for 3 min. During this time, blood pressure and heart rate will be measured. After removal of the hand from the warm water, skin temperature of the thumbpad will be recorded and participants will listen to a standardized script describing the procedures. Participants will then immerse the left hand into the cold water bath, and will be instructed to report the first painful sensation after immersion. They will then be asked to tolerate the stimulus as long as possible, but will be permitted to withdraw their hand from the cold water at any point. Maximum immersion time will be 2 min. Latency to first feel pain (pain sensitivity) and latency to withdraw the hand from the water (pain tolerance) will be recorded. Blood pressure and heart rate will be measured before and after each immersion using the arm that was not immersed in the water bath.

The Cannabis Withdrawal Scale is an assessment tool used to quantify the presence and intensity of various withdrawal symptoms (e.g., strange dreams, mood swings, depression, lack of appetite, and an inability to get to sleep).

Lane Tracking: This task requires subjects to drive down a straight 2-lane road, maintain a constant speed of 55 mph, maintain appropriate lane position, and respond to divided attention tasks in the upper corners of the screen. The primary outcomes are standard deviation of lateral deviation (swerving).
Car Following: This simulation examines the participant's ability to closely match the speed of an automobile in front of them. Participants are to follow a lead vehicle at a safe and constant distance. The primary outcomes is coherence between the participant and lead cars (a general correlation [0-1] of the participant's ability to accurately track the speed variations of the lead car.

dronabinol/back pain

Trial of Dronabinol and Vaporized Cannabis in Neuropathic Low Back Pain

Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

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